A Phase 2a Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of KAN-101 In Participants With Celiac Disease
Phase: PHASE2
Conditions: Celiac Disease, Coeliac Disease
Sponsor: Kanyos Bio, Inc., a wholly-owned subsidiary of Anokion SA

KAN-101
Protocol KAN-101-03
Final Protocol Amendment 01, 20 March 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
Page 1
Title Page
A PHASE 2A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO 
EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF KAN-101 IN 
PARTICIPANTS WITH CELIAC DISEASE
Study Intervention Number:
KAN-101
Study Intervention Name:
NA
US IND Number:
19492
EudraCT/EU CT Number:
2023-507240-37-00
ClinicalTrials.gov ID:
NCT 06001177
Pediatric Investigational Plan 
Number:
NA
Protocol Number:
KAN-101-03
Phase:
Phase 2a
Sponsor Legal Address: 
Anokion SA
50 Hampshire Street, Suite 402, Cambridge, 
MA 02149, USA
Brief Title:
A Study of the Efficacy, Safety, and Tolerability of KAN-101 in Participants With 
Celiac Disease
This document and accompanying materials contain confidential information belonging to Kanyos Bio, 
Inc., a wholly owned subsidiary of Anokion SA as Sponsor, and Pfizer. Except as otherwise agreed to in 
writing, by accepting or reviewing these documents, you agree to hold this information in confidence and 
not copy or disclose it to others (except where required by applicable law) or use it for unauthorized 
purposes. In the event of any actual or suspected breach of this obligation, Kanyos Bio, Inc. and Pfizer 
must be promptly notified.
090177e1a041c2d5\Approved\Approved On: 22-Mar-2024 13:52 (GMT)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 2  
D oc u me nt Hist or y  
D oc u me nt  
Versi o n D ate  
S u m m ar y of C h a n ges a n d 
R ati o n ale  
Ori gi nal pr ot oc ol  
0 6 Se pte m ber 2 0 2 3  
N/ A  
A me n d me nt 1  
2 0  Marc h 2 0 2 4  
Gl o bal A me n d me nt:  T he rati o nale f or 
t he a me n d me nt is relate d t o t he 
P A R T 1 q uesti o ns recei ve d fr o m t he 
E U C T A , s u b mitte d 2 7 N o v 2 0 2 3. 
 
C o ver Pa ge of t he pr ot oc ol  a n d 
s y n o psis: a d de d t he N C T n u m ber. 
J ustificati o n: re m o ve d T B D.  
 
Secti o n 1. 0, Sc he d ule of assess me nts, 
a d de d a b bre viati o ns u n der t he S O A , 
a n d Ta bles  1,  2, 3 , a n d 4  
J ustificati o n: T o pr o vi de pr ot oc ol 
clarit y base d o n t he res p o nses t o t he 
q uesti o ns recei ve d fr o m E U C T A 
re vie w.  
 
Secti o n 4. 3, J ustificati o n f or d ose ; 
u p date d wit h i nf or mati o n t o s u p p ort 
d ose fre q ue nc y. 
J ustificati o n: T o pr o vi de pr ot oc ol 
clarit y base d o n t he  res p o nses t o t he 
q uesti o ns recei ve d fr o m E U C T A 
re vie w.  
 
Secti o n 8. 2. 4. 1, Hi st ol o g y 
assess me nts ; u p date d secti o n t o 
pr o vi de a p pr o xi mate rate of scree n 
fail ures relate d t o hist ol o g y 
re q uire me nts. 
J ustificati o n: T o pr o vi de pr ot oc ol 
clarit y base d o n t he res p o nses t o t he 
q uesti o ns recei ve d fr o m E U C T A 
re vie w.  
 
 
Secti o n 8. 4. 4 , Re g ulat or y re p orti n g 
re q uire me nts f or seri o us a d verse 
e ve nts, S A Es; U p date d secti o n wit h 
re g ulat or y a ut h orities U S  F D A, a n d 
E U E u dra Vi gila nce . 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 3  
D oc u me nt  
Versi o n D ate  
S u m m ar y of C h a n ges a n d 
R ati o n ale  
J ustificati o n: T o pr o vi de pr ot oc ol 
clarit y base d o n t he res p o nses t o t he 
q uesti o ns recei ve d fr o m E U C T A 
re vie w.  
 
  
 Secti o n 9. 5, I nteri m A nal yses, (I A) 
a n d s y n o psis u p date d t o pr o vi de 
rati o nale f or ha vi n g t he I A.   
J ustificati o n: T o pr o vi de pr ot oc ol 
clarit y base d o n t he res p o nses t o t he 
q uesti o ns recei ve d fr o m E U C T A 
re vie w.  
 
 
Secti o n 9. 6  a n d s y n o psis  Sa m ple size 
deter mi nati o n; c orrecte d a t y p o fr o m 
9 9 % t o 9 4 %  ap pr o xi mate p o wer , a n d 
0. 4 t o 0. 5 f or sta n dar d de viati o n .  
A d de d dr o p o ut rate  of 3 0 % t o 
deter mi ne a differe nce of 0. 5  
e val ua ble s u bjects , i n t he f ull a nal ysis 
set. 
J ustificati o n: T o pr o vi de pr ot oc ol 
clarit y base d o n t he res p o nses t o t he 
q uesti o ns recei ve d fr o m E U C T A 
re vie w.  
 
Secti o n 1 0. 0, A p pe n di x 1, S u p p orti n g  
d oc u me ntati o n a n d o perati o nal 
c o nsi derati o ns ; U p date d secti o n wit h , 
“I n a d diti o n t o t he safet y re p orti n g 
res p o nsi bilities t o t he S p o ns or i n 
Secti o n 1 0. 3. 4, a n d i n acc or da nce 
wit h l ocal re g ulati o ns.” 
J ustificati o n: T o pr o vi de pr ot oc ol 
clarit y base d o n t he res p o nses t o t he 
q uesti o ns recei ve d fr o m E U C T A 
re vie w.  
 
A p pe n di x 9. 0, I nf usi o n - relate d 
reacti o ns; u p date d, If t he reacti o n has 
n ot res ol ve d wit hi n “ 6 h o urs of st u d y 
dr u g pre parati o n”, als o  a d de d I n 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 4  
D oc u me nt  
Versi o n D ate  
S u m m ar y of C h a n ges a n d 
R ati o n ale  
cases w here i nf usi o n has starte d b ut 
ca n n ot be c o m plete d wit h 6 h o urs of 
st u d y dr u g pre parati o n, t he re mai n der 
of t he i nf usi o n will n ot be 
a d mi nistere d a n d st u d y i nter ve nti o n 
will be per ma ne ntl y disc o nti n ue d.  
J ustificati o n: T o pr o vi de pr ot oc ol 
clarit y base d o n t he  res p o nses t o t he  
q uesti o ns recei ve d fr o m E U C T A 
re vie w.  
 
 
Secti o n 1 0. 1. 1 1 , P u blicati o n p olic y,  
u p date d to see  secti o n 1 0. 1. 6 
J ustificati o n: T o pr o vi de pr ot oc ol 
clarit y base d o n t he res p o nses t o t he 
q uesti o ns recei ve d fr o m E U C T A 
re vie w.  
 
 
Refere nces, Secti o n 1 1. 0,  a d de d 
refere nce A del ma n D C, M urra y J, 
W u T T, et al. Meas uri n g c ha n ge i n 
s mall i ntesti nal hist ol o g y i n patie nts 
wit h celiac disease. T he A merica n 
J o ur nal of Gastr oe nter ol o g y. 2 0 1 8. 
1 1 3: 3 3 9 -4 7.   
J ustificati o n: T o pr o vi de pr ot oc ol 
clarit y base d o n t he res p o nses t o t he 
q uesti o ns recei ve d fr o m E U C T A 
re vie w.  
Secti o n 1 0. 1. 1 2  S p o ns or’s Me dicall y 
Q ualifie d I n di vi d ual ; u p date d t o 
re place e mer ge nc y c o ntact car ds wit h 
a st u d y i nf or mati o n car d.   
J ustificati o n: T he pr ocess f or 
c o ntacti n g a me dicall y q ualifie d 
i n di vi d ual has c ha n ge d fr o m a 
me dical escalati o n pr ocess via a 
Pfizer Call Ce nter t o direct cli nical 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 5  
D oc u me nt  
Versi o n D ate  
S u m m ar y of C h a n ges a n d 
R ati o n ale  
tea m c o ntact usi n g a St u d y Tea m 
C o ntact List  
 
I ncl usi o n of P A C L 1; Date d 0 5 
Ja n uar y 2 0 2 4; Secti o n 5. 0, I ncl usi o n 
criteria # 4 u p date d t o matc h t he 
s y n o psis. Re m o ve d details a b o ut 
la b orat or y ra n ges as n ot nee de d, als o 
u p date d A p pe n di x 2, Ta ble 3; 
pr ot oc ol re q uire d la b assess me nts  
J ustificati o n: D ue t o differe nces i n 
la b ra n ges, it was deci de d t o g o wit h 
t he la b la bels, of ne gati ve a n d wea k 
p ositi ve.  
T y p os c orrecte d. 
 
 
 
 
 
Secti o n 5. 2 Clarifie d E xcl usi o n 
Criteria 1 2  
J ustificati o n: T o pr o vi de pr ot oc ol 
clarit y base d o n t he res p o nses t o t he 
q uesti o ns recei ve d fr o m E U C T A 
re vie w  
 
Secti o n 1 0. 1 1 A d de d A S A P h ysical 
Stat us Classificati o n S yste m as a 
refere nce. 
J ustificati o n: T o pr o vi de pr ot oc ol 
clarit y base d o n t he res p o nses t o t he 
q uesti o ns recei ve d fr o m E U C T A 
re vie w 
 
Refere nces: A d de d A merica n 
S ocie nt y of A nest hesi ol o gists. 
State me nt o n A S A P h ysical Stat us 
Classificati o n S yste m. 2 0 2 0 . 
J ustificati o n: To pr o vi de pr ot oc ol 
clarit y base d o n t he res p o nses t o t he 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 6  
D oc u me nt  
Versi o n D ate  
S u m m ar y of C h a n ges a n d 
R ati o n ale  
q uesti o ns recei ve d fr o m E U C T A 
re vie w 
List of a b bre viati o ns  u p date d.  
J ustificati o n: A d de d a p pe n di x 1 1 
 
 
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 7  
T A B L E  O F C O N T E N T S  
LI S T O F T A B L E S  ...................................................................................................................1 2  
1. P R O T O C O L S U M M A R Y  ...................................................................................................1 3  
1. 1. S y n o psis  ..................................................................................................................1 3  
1. 2. Sc he ma  ....................................................................................................................2 0  
1. 3. Sc he d ule of Acti vities  .............................................................................................2 1  
2. I N T R O D U C TI O N  ...............................................................................................................2 6  
2. 1. St u d y Rati o nale  .......................................................................................................2 6  
2. 2. Bac k gr o u n d  .............................................................................................................2 6  
2. 2. 1. Celiac Disease  .............................................................................................2 6  
2. 2. 2. K A N -1 0 1  ....................................................................................................2 7  
2. 2. 3. Cli nical O ver vie w  .......................................................................................2 7  
2. 3. Be nefit/ Ris k Assess me nt  .........................................................................................2 9  
2. 3. 1. Ris k Assess me nt  .........................................................................................3 0  
2. 3. 2. Be nefit Assess me nt  .....................................................................................3 2  
2. 3. 3. O verall Be nefit/ Ris k C o ncl usi o n  ................................................................3 2  
3. O BJ E C TI V E S, E N D P OI N T S, A N D E S TI M A N D S  ...........................................................3 2  
4. S T U D Y D E SI G N .................................................................................................................3 4  
4. 1. O verall Desi g n  .........................................................................................................3 4  
4. 2. Scie ntific Rati o nale f or St u d y Desi g n  .....................................................................3 5  
4. 2. 1. C h oice of C o ntrace pti o n/ Barrier Re q uire me nts  .........................................3 5  
4. 3. J ustificati o n f or D ose  ..............................................................................................3 6  
4. 4. E n d of St u d y Defi niti o n  ..........................................................................................3 6  
5. S T U D Y P O P U L A TI O N  ......................................................................................................3 6  
5. 1. I ncl usi o n Criteria  .....................................................................................................3 7  
5. 2. E xcl usi o n Criteria  ....................................................................................................3 8  
5. 3. Lifest yle C o nsi derati o ns  ..........................................................................................4 0  
5. 3. 1.  C o ntrace pti o n  ..............................................................................................4 0  
5. 3. 2. Meals a n d Dietar y Restricti o ns  ...................................................................4 1  
5. 3. 3. Caffei ne, Alc o h ol, a n d T o bacc o  .................................................................4 1  
5. 3. 4. Acti vit y  .......................................................................................................4 1  
5. 4. Scree n Fail ures  ........................................................................................................4 1  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 8  
6. S T U D Y I N T E R V E N TI O N( S) A N D C O N C O MI T A N T T H E R A P Y  .................................4 2  
6. 1. St u d y I nter ve nti o n(s) A d mi nistere d  ........................................................................4 2  
6. 1. 1. A d mi nistrati o n  ............................................................................................4 3  
6. 2. Pre parati o n, Ha n dli n g, St ora ge, a n d Acc o u nta bilit y  ...............................................4 4  
6. 2. 1. Pre parati o n a n d Dis pe nsi n g  ........................................................................4 5  
6. 3. Assi g n me nt t o St u d y I nter ve nti o n  ...........................................................................4 5  
6. 4. Bli n di n g  ...................................................................................................................4 5  
6. 4. 1. Bli n di n g of Partici pa nts  ..............................................................................4 5  
6. 4. 2. Bli n di n g of Site Pers o n nel  ..........................................................................4 5  
6. 4. 3. Bli n di n g of t he S p o ns or  ..............................................................................4 6  
6. 4. 4. Brea ki n g t he Bli n d  ......................................................................................4 6  
6. 5. St u d y I nter ve nti o n C o m plia nce  ...............................................................................4 6  
6. 6. D ose M o dificati o n  ...................................................................................................4 7  
6. 7. C o nti n ue d Access t o St u d y I nter ve nti o n After t he E n d of t he St u d y  ......................4 7  
6. 8. Treat me nt of O ver d ose  ............................................................................................4 7  
6. 9. Pri or a n d C o nc o mita nt T hera p y  ..............................................................................4 7  
6. 9. 1. Pr o hi bite d D uri n g t he St u d y  .......................................................................4 7  
6. 9. 2. Per mitte d D uri n g t he St u d y  ........................................................................4 8  
6. 9. 3. Resc ue Me dici ne  .........................................................................................4 9  
7. DI S C O N TI N U A TI O N O F S T U D Y I N T E R V E N TI O N A N D P A R TI CI P A N T 
DI S C O N TI N U A TI O N/ WI T H D R A W A L  ...........................................................................4 9  
7. 1. Disc o nti n uati o n of St u d y I nter ve nti o n  ....................................................................4 9  
7. 1. 1. Li ver I nj ur y  .................................................................................................5 0  
7. 1. 2. Pre g na nc y  ...................................................................................................5 0  
7. 1. 3. C O VI D -1 9  ..................................................................................................5 0  
7. 1. 4. Te m p orar y Disc o nti n uati o n  ........................................................................5 0  
7. 2. Partici pa nt Disc o nti n uati o n/ Wit h dra wal Fr o m t he St u d y  .......................................5 0  
7. 2. 1. Wit h dra wal of C o nse nt  ...............................................................................5 1  
7. 3. L ost t o F oll o w -U p  ...................................................................................................5 1  
8. S T U D Y A S S E S S M E N T S A N D P R O C E D U R E S  ...............................................................5 2  
8. 1. A d mi nistrati ve Pr oce d ures  ......................................................................................5 2  
8. 1. 1. Tele healt h Visits  .........................................................................................5 3  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 9  
8. 2. Efficac y Assess me nts  ..............................................................................................5 3  
8. 2. 1. Gl ute n C halle n ge  ........................................................................................5 3  
8. 2. 2. Plas ma I L -2 Bi o mar ker Assess me nt  ...........................................................5 4  
8. 2. 3. Patie nt Re p orte d O utc o mes  ........................................................................5 4  
8. 2. 3. 1. C D S D v 2. 1  ................................................................................5 4  
8. 2. 3. 2. P GI C  ..........................................................................................5 4  
8. 2. 3. 3. P GI S  ..........................................................................................5 4  
8. 2. 4. Es o p ha g o gastr o d u o de n osc o p y Wit h Bi o ps y  ..............................................5 4  
8. 2. 4. 1. Hist ol o gical Assess me nts  ..........................................................5 5  
8. 3. Safet y Assess me nts  .................................................................................................5 5  
8. 3. 1. I nci de ntal Gl ute n E x p os ure Assess me nt  ....................................................5 6  
8. 3. 2. Vital Si g ns  ..................................................................................................5 6  
8. 3. 3. Electr ocar di o gra ms  .....................................................................................5 6  
8. 3. 4. Cli nical Safet y La b orat or y Assess me nts  ....................................................5 7  
8. 3. 4. 1. Alter nati ve Facilities f or Cli nical Safet y La b orat or y 
Assess me nt  ........................................................................................5 7  
8. 3. 5. P h ysical E xa mi nati o ns  ................................................................................5 8  
8. 3. 6. Pre g na nc y Testi n g  ......................................................................................5 8  
8. 4. A d verse E ve nts, Seri o us A d verse E ve nts, a n d Ot her Safet y Re p orti n g  .................5 8  
8. 4. 1. Ti me Peri o d a n d Fre q ue nc y f or C ollecti n g A E a n d S A E I nf or mati o n  .......5 9  
8. 4. 1. 1. Re p orti n g S A Es t o t he Pfizer Safet y  .........................................5 9  
8. 4. 1. 2. Rec or di n g N o nseri o us A Es a n d S A Es o n t he C R F  ...................6 0  
8. 4. 2. Met h o d of Detecti n g A Es a n d S A Es  ..........................................................6 0  
8. 4. 3. F oll o w -U p of A Es a n d S A Es  ......................................................................6 0  
8. 4. 4. Re g ulat or y Re p orti n g Re q uire me nts f or S A Es  ...........................................6 0  
8. 4. 5. E n vir o n me ntal E x p os ure, E x p os ure D uri n g Pre g na nc y or 
Breastfee di n g, a n d Occ u pati o nal E x p os ure  .....................................................6 1  
8. 4. 5. 1. E x p os ure D uri n g pre g na nc y  ......................................................6 1  
8. 4. 5. 2. E x p os ure D uri n g Breastfee di n g  ................................................6 3  
8. 4. 5. 3. Occ u pati o nal E x p os ure  .............................................................6 3  
8. 4. 6. Car di o vasc ular a n d Deat h E ve nts  ...............................................................6 3  
8. 4. 7. Disease -Relate d E ve nts a n d/ or Disease -Relate d O utc o mes N ot 
Q ualif yi n g as A Es or S A Es  ..............................................................................6 3  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 0  
8. 4. 8. A d verse E ve nts of S pecial I nterest  .............................................................6 3  
8. 4. 8. 1. Lac k of Efficac y  ........................................................................6 3  
8. 4. 9. Me dical De vice Deficie ncies  ......................................................................6 3  
8. 4. 1 0. Me dicati o n Err ors  .....................................................................................6 4  
8. 5. P har mac o ki netics  ....................................................................................................6 4  
8. 6. Ge netics  ...................................................................................................................6 5  
8. 6. 1. S pecifie d Ge netics  ......................................................................................6 5  
8. 7. Bi o mar kers  ..............................................................................................................6 5  
8. 7. 1. Resi d ual Researc h Sa m ples f or Bi o mar kers  ...............................................6 6  
8. 8. I m m u n o ge nicit y Assess me nts  .................................................................................6 6  
8. 9. Healt h Ec o n o mics  ...................................................................................................6 7  
9. S T A TI S TI C A L C O N SI D E R A TI O N S .................................................................................6 7  
9. 1. Statistical H y p ot heses  .............................................................................................6 7  
9. 2. Esti ma n ds  ................................................................................................................6 7  
9. 2. 1. Pri mar y Esti ma n d  .......................................................................................6 7  
9. 2. 1. 1. Sec o n dar y Esti ma n ds  ................................................................6 8  
9. 2. 2. M ulti plicit y A dj ust me nt  ..............................................................................6 8  
9. 3. A nal ysis Sets  ...........................................................................................................6 9  
9. 4. Statistical A nal yses  .................................................................................................6 9  
9. 4. 1. Ge neral C o nsi derati o ns  ...............................................................................6 9  
9. 4. 1. 1. A nal yses f or C o nti n u o us E n d p oi nts  ..........................................6 9  
9. 4. 1. 2. Missi n g Data Ha n dli n g  ..............................................................7 0  
9. 4. 2. Pri mar y E n d p oi nts/ Esti ma n ds A nal ysis  .....................................................7 0  
9. 4. 2. 1. Defi niti o n of E n d p oi nts  .............................................................7 0  
9. 4. 2. 2. Mai n A nal ytical A p pr oac h  ........................................................7 0  
9. 4. 2. 3. Se nsiti vit y/ S u p p orti ve A nal ytical A p pr oac h  .............................7 0  
9. 4. 3. Sec o n dar y E n d p oi nts A nal ysis  ...................................................................7 0  
9. 4. 3. 1. C ha n ge i n I L -2 fr o m pre G C t o p ost G C at Da y 1 5 ( First 
Da y of G C)  ........................................................................................7 0  
9. 4. 3. 2. C ha n ges fr o m baseli ne i n I E L i n d u o de n u m bi o ps y at Da y 
2 9 Visit  ..............................................................................................7 0  
9. 4. 3. 3. I nci de nce a n d se verit y of T E A Es a n d I nci de nce a n d titer 
of K A N -1 0 1 A D A  .............................................................................7 0  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 1  
9. 4. 3. 4. Plas ma c o nce ntrati o n of K A N -1 0 1, a n d ass ociate d K A N -
1 0 1 para meters: A U Ci nf, A U Clast, C ma x, T ma x a n d t ½  .................7 0  
9. 4. 4.  Tertiar y/ E x pl orat or y E n d p oi nts  A nal ysis  ...................................................7 1  
9. 4. 5. P har mac o ki netic A nal ysis  ..........................................................................7 1  
9. 4. 6. Safet y A nal yses  ..........................................................................................7 2  
9. 4. 7.  Ot her  A nal yses  ............................................................................................7 2  
9. 5. I nteri m A nal yses  .....................................................................................................7 2  
9. 6. Sa m ple Size Deter mi nati o n  .....................................................................................7 2  
1 0. S U P P O R TI N G D O C U M E N T A TI O N A N D O P E R A TI O N A L 
C O N SI D E R A TI O N S  ..........................................................................................................7 3  
1 0. 1. A p pe n di x 1: Re g ulat or y, Et hical, a n d St u d y O versi g ht C o nsi derati o ns  ...............7 3  
1 0. 1. 1.  Re g ulat or y  a n d Et hical C o nsi derati o ns  ....................................................7 3  
1 0. 1. 1. 1. Re p orti n g of Safet y Iss ues a n d Seri o us Breac hes of t he 
Pr ot oc ol or I C H G C P  .........................................................................7 3  
1 0. 1. 2. Fi na ncial Discl os ure  .................................................................................7 4  
1 0. 1. 3. I nf or me d C o nse nt Pr ocess  ........................................................................7 4  
1 0. 1. 4. Data Pr otecti o n  .........................................................................................7 5  
1 0. 1. 5. C o m mittees Str uct ure  ...............................................................................7 6  
1 0. 1. 5. 1.  Data M o nit ori n g C o m mittee  ...................................................7 6  
1 0. 1. 6. Disse mi nati o n of Cli nical St u d y Data  ......................................................7 6  
1 0. 1. 7. Data Q ualit y Ass ura nce  ............................................................................7 7  
1 0. 1. 8. S o urce D oc u me nts  ....................................................................................7 8  
1 0. 1. 9. Use of Me dical Rec or ds  ............................................................................7 9  
1 0. 1. 1 0. St u d y a n d Site Start a n d Cl os ure  ............................................................7 9  
1 0. 1. 1 1. P u blicati o n P olic y  ...................................................................................8 0  
1 0. 1. 1 2. S p o ns or’s Me dicall y Q ualifie d I n di vi d ual  ..............................................8 0  
1 0. 2. A p pe n di x 2: Cli nical La b orat or y Tests  .................................................................8 1  
1 0. 3. A p pe n di x 3: A d verse E ve nts: Defi niti o ns a n d Pr oce d ures f or Rec or di n g, 
E val uati n g, F oll o w -U p, a n d Re p orti n g  .....................................................................8 3  
1 0. 3. 1. Defi niti o n of A E  .......................................................................................8 3  
1 0. 3. 2. Defi niti o n of a n S A E  ................................................................................8 4  
1 0. 3. 3. Rec or di n g/ Re p orti n g a n d F oll o w -U p of A Es a n d/ or S A Es D uri n g 
t he Acti ve C ollecti o n Peri o d ............................................................................8 5  
1 0. 3. 4. Re p orti n g of S A Es  ....................................................................................8 9  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 2  
1 0. 4. A p pe n di x 4: C o ntrace pti ve a n d Barrier G ui da nce  ................................................9 0  
1 0. 4. 1. Male Partici pa nt Re pr o d ucti ve I ncl usi o n Criteria  ....................................9 0  
1 0. 4. 2. Fe male Partici pa nt Re pr o d ucti ve I ncl usi o n Criteria  .................................9 0  
1 0. 4. 3. W o ma n of C hil d beari n g P ote ntial  ............................................................9 1  
1 0. 4. 4. C o ntrace pti o n Met h o ds  .............................................................................9 2  
1 0. 5. A p pe n di x 5: Ge netics  ............................................................................................9 4  
1 0. 6.  A p pe n di x 6: Li ver Safet y: S u g geste d Acti o ns a n d F oll o w -U p Assess me nts  .......9 5  
1 0. 7. A p pe n di x 7: Ki d ne y Safet y M o nit ori n g G ui deli nes  .............................................9 7  
1 0. 7. 1. La b orat or y Assess me nt of C ha n ge i n Ki d ne y F u ncti o n a n d 
Detecti o n of Ki d ne y I nj ur y  ..............................................................................9 7  
1 0. 7. 2. A ge -S pecific Ki d ne y F u ncti o n Calc ulati o n Rec o m me n dati o ns  ...............9 7  
1 0. 7. 2. 1. A d ults ( 1 8 Years a n d A b o ve) — 2 0 2 1 C K D -E PI 
E q uati o ns  ...........................................................................................9 7  
1 0. 7. 3. Ki d ne y F u ncti o n Calc ulati o n T o ols  ..........................................................9 8  
1 0. 7. 4. A d verse E ve nt Gra di n g f or Ki d ne y Safet y La b orat or y 
A b n or malities  ...................................................................................................9 8  
1 0. 8. A p pe n di x 8: E C G Fi n di n gs of P ote ntial Cli nical C o ncer n  ...................................9 9  
1 0. 9. A p pe n di x 9: I nf usi o n -Relate d Reacti o ns  ............................................................1 0 1  
1 0. 1 0. A p pe n di x 1 0: C o m m o n Ter mi n ol o g y Criteria F or A d verse E ve nts  .................1 0 3  
1 0. 1 1. A p pe n di x 1 1: A S A P h ysical Stat us Classificati o n S yste m  ...............................1 0 5  
1 0. 1 2. A p pe n di x 1 2: A b bre viati o ns  .............................................................................1 0 6  
1 1. R E F E R E N C E S  ................................................................................................................1 1 0  
 
 
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 3  
LI S T O F T A B L E S  
Ta ble 1.  
Sc he d ule of Assess me nts  ..........................................................................2 0  
Ta ble 2.  
P K Para meters A nal yze d  ..........................................................................7 0  
Ta ble 3.  
Pr ot oc ol -Re q uire d La b orat or y Assess me nts  .............................................8 1  
Ta ble  4.  
C T C A E v 6. 0 or Hi g her Gra des f or GI Dis or ders O bser ve d i n K A N -
1 0 1 -0 1 ( FI H St u d y)  .................................................................................1 0 3  
 
 
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 4  
1.  P R O T O C O L S U M M A R Y  
1. 1.  S y n o psis   
Pr ot oc ol Title:   
A P hase 2a D o u ble -Bli n d, Place b o -C o ntr olle d St u d y to E val uate the Efficac y, Safet y, an d 
T olera bilit y o f KA N -1 0 1 I n Partici pa nts Wit h Celiac Disease  
Brief  Title:   
A S t u d y of t he Efficac y, Safet y, a n d T olera bilit y  of  K A N -1 0 1  i n Partici pa nts W it h Celiac 
Disease  
Re g ul at or y A ge nc y I de ntific ati o n N u m ber(s):  
U S I N D N u m ber:  
1 9 4 9 2  
E u d r a C T/ E U C T N u m ber:  
2 0 2 3 -5 0 7 2 4 0 -3 7 -0 0  
Cli nic al Tri als. g o v I D:   
 N C T 0 6 0 0 1 1 7 7  
Pe di atric I n vesti g ati o n al Pl a n N u m ber : 
N A  
Pr ot oc ol N u m ber:  
K A N -1 0 1 -0 3  
P h ase:  
P hase 2a  
 
R ati o n ale : 
T he s p o ns or is i nitiati n g t his P hase 2a st u d y of K A N -1 0 1 i n a d ult partici pa nts wit h  celiac 
disease ( Ce D ) t o i n vesti gate t he a bilit y of K A N-1 0 1 t o pr otect i ntesti nal m uc osa fr o m gl ute n -
i n d uce d hist ol o gical  da ma ge .  
O bjecti ves , E n d p oi nts , a n d Esti m a n ds : 
O bjecti ves  
E n d p oi nts  
Esti m a n ds  
Pri m ar y:  
Pri m ar y:  
Pri m ar y:  
•  
Assess t he a bilit y 
of K A N -1 0 1 t o 
atte n uate gl ute n 
c halle n ge ( G C )-
i n d uce d c ha n ges 
i n d u o de nal 
hi st ol o g y as 
meas ure d b y 
c ha n ges i n vill us -
hei g ht:cr y pt de pt h 
(V h: C d ) rati o 
after a 2 -wee k 
G C . 
•  C ha n ges fr o m baseli ne i n 
V h: C d  rati o as assesse d b y 
es o p ha g o gastr o d u o de n osc o p y  
(E G D ) wit h bi o ps y  after 2 -
wee k G C  (at Da y 2 9) 
Esti m a n d 1:  T he pri mar y esti ma n d is t he h y p ot hetical 
esti ma n d, w hic h esti mates t he treat me nt effect of K A N -1 0 1 
vs p lace b o f or c ha n ge fr o m baseli ne i n t he rati o of V h: C d 
u n der t he sce nari o of n o i nterc urre nt e ve nts. It i ncl u des t he 
f oll o wi n g 5 attri b utes: 
•  
P o p ulati o n : Partici pa nts w h o recei ve all 3 d oses of 
st u d y i nter ve nti o n a n d c o m plete at least 7 da ys of 
G C.   
•  
Varia ble : t he rati o of V h: C d c ha n ge fr o m baseli ne 
at Da y 2 9 . 
•  
Treat me nt c o n diti o ns : K A N-1 0 1 or place b o . 
•  
I nterc urre nt E ve nts: Pr o hi bite d me dicati o n. All data 
c ollecte d after a n y i nterc urre nt e ve nts will be 
e xcl u de d.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 5  
O bjecti ves  
E n d p oi nts  
Esti m a n ds  
•  
P o p ulati o n le vel s u m mar y: T he L S M differe nce of 
t he c ha n ge fr o m baseli ne i n t he rati o of V h: C d 
bet wee n K A N -1 0 1 a n d place b o . 
Sec o n d ar y:  
Sec o n d ar y:  
Sec o n d ar y:  
•  
E xa mi ne t he 
i m pact of K A N-
1 0 1 o n bi o mar ker 
res p o nse 
(i nterle u ki n-2 [ I L-
2 ]) i n peri p heral 
bl o o d f oll o wi n g 
G C  
•  I L-2 c ha n ge fr o m Da y 1 5  
(first da y of G C) pre G C  t o 
Da y 1 5  p ost G C . 
Esti m a n d 2  is t he h y p ot hetical esti ma n d, w hic h esti mates t he 
treat me nt effect of K A N-1 0 1 vs Place b o f or I L -2 u n der t he 
sce nari o of n o i nterc urre nt e ve nts. It i ncl u des t he f oll o wi n g 5 
attri b utes: 
•  
P o p ulati o n : Partici pa nts w h o recei ve all 3 d oses of 
st u d y i nter ve nti o n a n d c o m plete at least 7 da ys of 
G C.   
•  
Varia ble : l o g tra nsf or me d I L-2 c ha n ge fr o m pre G C 
t o p ost G C at Da y 1 5. 
•  
Treat me nt c o n diti o ns : K A N-1 0 1 or place b o . 
•  
I nterc urre nt E ve nts: Pr o hi bite d me dicati o n, 
i nc o m plete G C o n Da y 1 5. All data c ollecte d after 
a n y i nterc urre nt e ve nts will be e xcl u de d.  
•  
P o p ulati o n le vel s u m mar y: T he least-s q uares mea n 
(L S M ) differe nce of t he c ha n ge fr o m pre G C t o 
p ost G C at Da y 1 5 (l o g tra nsf or me d) bet wee n 
K A N -1 0 1 a n d place b o . 
•  
Deter mi ne t he 
effects of K A N -
1 0 1 o n  hist ol o gic 
feat ures 
(i ntrae pit helial 
l y m p h oc ytes 
[I E Ls] de nsit y ) i n 
d u o de n u m bi o psies 
f oll o wi n g 2-wee k 
G C.  
•  C ha n ges fr o m baseli ne i n I E L  
de nsit y  i n d u o de n u m bi o ps y 
after 2 -wee k G C  (at Da y 2 9) 
Esti m a n d 3  is t he h y p ot hetical esti ma n d, w hic h esti mates t he 
treat me nt effect of K A N-1 0 1 vs place b o f or c ha n ge fr o m 
baseli ne i n d u o de nal I E L de nsit y  u n der t he sce nari o of n o 
i nterc urre nt e ve nts. It i ncl u des t he f oll o wi n g 5 attri b utes: 
•  
P o p ulati o n : Partici pa nts w h o recei ve all 3 d oses of 
st u d y i nter ve nti o n a n d c o m plete at least 7 da ys of 
G C.  
•  
Varia ble : I E L c ha n ge fr o m baseli ne at Da y 2 9 . 
•  
Treat me nt c o n diti o ns : K A N-1 0 1 or place b o.  
•  
I nterc urre nt E ve nts: Pr o hi bite d me dicati o n. All data 
c ollecte d after a n y i nterc urre nt e ve nts will be 
e xcl u de d.  
•  
P o p ulati o n le vel s u m mar y: T he L S M differe nce of 
t he c ha n ge fr o m baseli ne i n I E L bet wee n K A N-1 0 1 
a n d place b o.  
•  
Assess t he safet y 
a n d t olera bilit y of 
K A N -1 0 1 i n 
partici pa nts wit h 
Ce D.  
 
•  I nci de nce a n d se verit y of 
treat me nt e mer ge nt A Es as 
assesse d b y t he C o m m o n 
Ter mi n ol o g y Criteria f or 
A d verse E ve nts ( C T C A E ) 
v 6. 0 ( or hi g her)  
N ot a p plica ble.  
•  I nci de nce a n d titer of K A N-
1 0 1 a nti-dr u g a nti b o dies 
(A D A ) 
N ot a p plica ble.  
•  
Assess t he 
p har mac o ki netics 
(P K ) of m ulti ple 
d oses of K A N -1 0 1 
i n partici pa nts wit h 
Ce D.  
•  Plas ma c o nce ntrati o n of 
K A N -1 0 1, a n d ass ociate d 
K A N -1 0 1 para meters: 
A U C i nf, A U C last, C ma x , T ma x  
a n d t½   
N ot a p plica ble.  
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 6  
D ose Selecti o n: Base d o n K A N -1 0 1 -0 1 st u d y res ults, 0. 6 m g/ k g of K A N -1 0 1 a d mi nistere d 
i n 3 d oses 3 da ys a part, will be e val uate d. T he fre q ue nc y of d osi n g i n t he st u d y is s u p p orte d 
b y t he n o n cli nical, e x peri me ntal a ut oi m m u ne e nce p hal o m yelitis ( E A E ) m o use m o del t hat 
de m o nstrate d t hat d osi n g e ver y 3 da ys o ver o ne wee k  was m ore effecti ve t ha n o nce per wee k  
d osi n g. Cli nical bi o mar ker data fr o m t he K A N -1 0 1 -0 1 first-i n-h u ma n  (FI H ) st u d y als o 
s u g gest t hat t his d osi n g re gi me n is effecti ve a n d a p pr o priate i n a d ults wit h Ce D.  
O ver all Desi g n : 
St u d y K A N -1 0 1 -0 3 is a m ulti -ce nter, d o u ble -bli n d, place b o -c o ntr olle d P hase 2a st u d y t o 
e xa mi ne  w het her K A N -1 0 1 c o nfers  pr otecti o n fr o m G C -i n d uce d hist ol o gical c ha n ges i n t he 
d u o de n u m  a n d t o f urt her e val uate t he safet y/t olera bilit y of K A N -1 0 1 i n a d ult partici pa nts  
(≥1 8 years) wit h Ce D. Fift y -t w o partici pa nts  ( 2 6 partici pa nts  per ar m) will be ra n d o mize d 
1: 1 t o t he f oll o wi n g ar ms: 0 . 6 m g/ k g K A N -1 0 1 ( Ar m 1 ) a n d Pl ace b o ( Ar m 2 ). T his st u d y 
c o m prises 4 peri o ds : 
Scree ni n g  p eri o d: T he st u d y scree ni n g peri o d is ≤4 2 da ys. D uri n g t he scree ni n g peri o d, 
eli gi bilit y will be c o nfir me d b y E G D wit h d u o de nal bi o ps y. T he E G D wit h bi o ps y will o nl y 
be perf or me d o nce all ot her i ncl usi o n criteria are f ulfille d . Hist ol o g y res ults m ust be recei ve d 
pri or t o d osi n g  t o c o nfir m eli gi bilit y.  
Treat me nt p eri o d: T he st u d y treat me nt peri o d is 7 da ys ( Da y 1 t o Da y 7). St u d y i nter ve nti o n 
will be a d mi nistere d t o e nr olle d partici pa nts i n t he cli nic i ntra ve n o usl y (I V) o n Da y 1, Da y 4, 
a n d Da y 7. P ost i nf usi o n eac h treat me nt da y, partici pa nts  will be m o nit ore d i n t he cli nic f or  
at least  4 h o urs f or a d verse reacti o ns.  
G C : Partici pa nts will u n der g o a 2 -wee k G C i n w hic h t he y will i n gest 9  g/ da y of gl ute n 
pr otei n i n t he f or m of 1 2  g vital w heat gl ute n. All partici pa nts will ret ur n t o t he cli nic o n 
Da y  1 5 f or t he first da y of G C. T he D a y 1 5 G C will be perf or me d i n t he cli nic u n der 
s u per visi o n a n d bl o o d sa m ples will be c ollecte d at least 5 mi n utes pri or t o G C a n d 4 h o urs 
after t he c o m pleti o n of t he Da y 1 5 G C f or bi o mar ker assess me nt. Materials will be se nt h o me 
wit h t he partici pa nt t o c o m plete t he G C dail y f or t he ne xt 2 wee k s (t hr o u g h Da y 2 8). T he 
st u d y site will call t he partici pa nt o n Da y 1 6 a n d Da y 2 1 t o c ollect data o n a n y A Es or C M 
o ver t he tele p h o ne. S y m pt o m m o nit ori n g a n d c o m plia nce wit h t he G C will be c o n d ucte d  via 
e Diar y. 
O bser vati o n a n d F oll o w -u p  peri o d : Partici pa nts will be o bser ve d a n d f oll o we d f or safet y f or 
t he d urati o n of t he st u d y (4 2 da ys [Da y 1 t o Da y 4 2 ]). T he sec o n d E G D wit h d u o de nal 
bi o ps y will be c o n d ucte d o n Da y 2 9 . Partici pa nts  will ret ur n t o t he cli nic o n Da y 4 2 f or a 
fi nal f oll o w-u p visit i ncl u di n g safet y assess me nt a n d la bs, celiac ser ol o g y, a n d e x pl orat or y 
bi o mar ker sa m ple c ollecti o ns.  
If partici pa nts  are u na ble t o ret ur n t o t he cli nic f or pr ot oc ol -s pecifie d visits, alter nati ve 
met h o ds f or safet y assess me nts a n d data c ollecti o n ma y be e m pl o ye d t o e ns ure t he safet y of 
t he trial partici pa nts w he n a p pr o priate. 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 7  
D at a S afet y M o nit ori n g B o ar d  ( D S M B): T his st u d y will utilize a D S M B t hat will be 
c o m p ose d of at least 2 p h ysicia ns, o ne of w hic h will be a Ce D me dical e x pert, a n d 1 
bi ostatisticia n. D S M B me m bers will be i n de pe n de nt fr o m t he c o n d uct of t he st u d y. T he 
D S M B safet y m o nit ori n g pla n will be detail e d i n t he D S M B c harter.  T he pri mar y 
res p o nsi bilit y of t he D S M B is t o safe g uar d st u d y partici pa nts  b y re vie wi n g a n d assessi n g t he 
c u m ulati ve cli nical safet y data bei n g c ollecte d d uri n g t he perf or ma nce of t he st u d y. T he 
D S M B will meet peri o dicall y t hr o u g h o ut t he st u d y t o re vie w c u m ulati ve safet y data.  
N u m ber of P artici p a nts:  It is a ntici pate d t hat t he st u d y will e nr oll a p pr o xi matel y 5 2 treate d 
partici pa nts .  
S t u d y P o p ul ati o n: Ke y  i ncl usi o n a n d e xcl usi o n criteria are liste d bel o w. 
Ke y  I ncl usi o n Criteri a  
Partici pa nts m ust meet t he f oll o wi n g ke y i ncl usi o n criteria t o be eli gi ble f or e nr oll me nt i nt o 
t he st u d y: 
1.  
A d ults  a ge d 1 8 t o 7 0  years i ncl usi ve .  
2.  
Pre vi o usl y d oc u me nte d dia g n osis of Ce D base d o n p ositi ve ser ol o g y (e g, tiss ue 
tra ns gl uta mi nase I g A a nti b o d y a n d/ or D G P I g G) A N D i ntesti nal hist ol o g y c o nsiste nt 
wit h ≥ Mars h T y pe II or wit h e vi de nce of vill o us atr o p h y . 
3.  
H L A -D Q 2. 5  ge n ot y pe ( H L A -D Q A 1 * 0 5 a n d H L A -D Q B 1 * 0 2) ( h o m oz y g otes or 
heter oz y g otes) . 
4.  
Ne gati ve or wea k p ositi ve f or tra ns gl uta mi nase I g A a n d ne gati ve or wea k p ositi ve f or 
D G P -I g A/I g G d uri n g scree ni n g. 
5.  
Ha ve  f oll o we d a gl ute n-free diet f or ≥1 2  m o nt hs i m me diatel y pri or t o st u d y e ntr y 
(self-re p orte d). 
6.  
Scree ni n g i ntesti nal bi o ps y de m o nstrati n g V h: C d rati o of 2. 3  or hi g her . 
Ke y E xcl usi o n Criteri a  
Partici pa nts  wit h a n y of t he f oll o wi n g ke y c haracteristics/c o n diti o ns will be e xcl u de d:  
1.  
Refract or y Ce D , defi ne d as se vere persiste nt or rec urre nt mala bs or pti ve si g ns or 
s y m pt o ms wit h s u bsta ntial vill o us atr o p h y (e g, d oc u me nte d Mars h sc ore 3c i n s o urce 
data)  des pite strict a d here nce t o a G F D f or at least 1 2 m o nt hs i n a bse nce of ot her 
dis or ders.  
2.  
Selecti ve I g A deficie nc y .  
3.  
P ositi ve f or H L A -D Q 8 ge n ot y pe ( D Q A 1 * 0 3, D Q B 1 * 0 3 0 2)  e ve n if D Q 2. 5 is als o 
prese nt.   
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 8  
4.  
K n o w n w heat aller g y . 
5.  
Dia g n osis of t y pe -I dia betes. 
6.  
Hist or y of der matitis her petif or mis . 
7.  
Pre g na nt or breastfee di n g .  
8.  
K n o w n hist or y of se vere h y perse nsiti vit y reacti o ns or a na p h yla xis t o gl ute n . 
9.  
Acti ve gastr oi ntesti nal disease ot her t ha n Ce D (e g, i nfla m mat or y b o wel disease, a n y 
f or ms of c olitis e xce pt well-c o ntr olle d micr osc o pic c olitis, u nc o ntr olle d I B S, pe ptic 
ulcer disease, e osi n o p hilic es o p ha gitis, a n d acti ve GI i nfecti o ns) . 
1 0.  Pre vi o us treat me nt wit h t olera nce -i n d uci n g t hera pies f or Ce D. 
St u d y Ar ms  a n d D ur ati o n : 
St u d y I nter ve nti o n(s)  
I nter ve nti o n N a me 
K A N -1 0 1  
Place b o ( Sali ne S ol uti o n)  
Ar m N a me  
( gr o u p of partici pa nts recei vi n g a 
s pecific treat me nt or n o treat me nt) 
K A N -1 0 1  ( Ar m 1) 
Place b o  ( Ar m 2)  
 
T y pe  
Dr u g  
 
Dr u g  
D ose F or m ul ati o n  
S ol uti o n f or i nf usi o n  
S ol uti o n f or i nf usi o n  
U nit D ose Stre n gt h(s)  
 
 
  
N A  
D os a ge Le vel(s)  
 
Place b o  
R o ute of A d mi nistr ati o n  
I V 
I V 
Use  
E x peri me ntal  
Place b o  
I M P or NI M P/ A x M P 
I M P 
Place b o  
S o urci n g  
Pr o vi de d ce ntrall y b y t he s p o ns or.  
F urt her details are prese nte d i n t he 
I P M. 
Pr o vi de d l ocall y b y t he site.  
F urt her details are prese nte d i n t he 
I P M. 
P ac k a gi n g a n d L a beli n g  
St u d y i nter ve nti o n will be pr o vi de d i n 
glass vials, 1 vial per cart o n. Eac h vial 
a n d cart o n will be la bele d as re q uire d 
per c o u ntr y re q uire me nts.  
St u d y i nter ve nti o n will be pre pare d 
per I P M i nstr ucti o ns a n d la bele d i n a 
Place b o will be pre pare d per I P M 
i nstr ucti o ns a n d la bele d i n a bli n de d 
ma n ner per c o u ntr y a n d site 
re q uire me nts. 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)
C CI
C CI

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 9  
St u d y I nter ve nti o n(s)  
bli n de d ma n ner per c o u ntr y a n d site 
re q uire me nts. 
I M P or NI M P/ A x M P: I n vesti gati o nal me dici nal pr o d uct, N o n i n vesti gati o nal me dici nal pr o d uct, a u xiliar y 
me dici nal pr o d uct , I P M: In vesti gati o nal pr o d uct ma n ual  
 
St atistic al Met h o ds : 
Sa m ple Size Deter mi nati o n : T he t otal sa m ple size is e x pecte d t o be a p pr o xi matel y 5 2 treate d 
partici pa nts.   
A t otal sa m ple size of 2 6 partici pa nts i n eac h treat me nt gr o u p will ha ve a p pr o xi matel y 
9 4 % p o wer t o detect a differe nce i n L S M of 0. 5 0 i n c ha n ge i n rati o of V h: C d bet wee n 
treat me nt a n d place b o, ass u mi n g t hat t he c o m m o n sta n dar d de viati o n is 0. 45 . Details of t he 
a nal yses will be descri be d i n t he statistical a nal ysis pla n . 
A n al ysis P o p ul ati o n  
All partici pa nts w h o recei ve a n y p orti o n of st u d y i nter ve nti o n will be i ncl u de d i n t he Safet y 
A nal ysis Set . All safet y data will be s u m marize d f or partici pa nts  i n t he Safet y A nal ysis Set.  
T he F ull A nal ysis Set  will c o nsist of all ra n d o mize d partici pa nts w h o recei ve all 3 d oses  of 
st u d y i nter ve nti o n a n d c o m plete at least 7 da ys of G C . 
T he Per Pr ot oc ol Set  will i ncl u de all partici pa nts fr o m t he F A S w h o c o m plete all 1 4 da ys of 
G C  a n d bi o psies  ( Baseli ne [ Da y 1] a n d Da y 2 9)  a n d wit h o ut maj or pr ot oc ol vi olati o ns  t hat 
mi g ht affect st u d y i nter ve nti o n o n t he pri mar y e n d p oi nt. T he P P S will be use d i n se nsiti vit y 
a nal yses of t he pri mar y a n d sec o n dar y e n d p oi nts.  
T he  P har mac o ki netic A nal ysis S et will c o ntai n all partici pa nts w h o recei ve d a n y p orti o n  of 
st u d y i nter ve nti o n a n d ha ve at least o ne p ost -d ose dr u g c o nce ntrati o n val ue.  
I nteri m A n al ysis: 
A pla n ne d I A will be perf or me d w he n a p pr o xi matel y 1 3 partici pa nts  fr o m eac h gr o u p ha ve 
c o m plete d t he Da y 2 9  visit a n d hist ol o g y assess me nts.   
U nless a safet y c o ncer n arises, n o decisi o n t o st o p t he trial will be ma de base d o n t his i nteri m 
a nal ysis . T he res ults of t he I A will be use d f or f ut ure  strate gic pla n ni n g f or t he o verall K A N -
1 0 1  pr o gra m . 
Pri m ar y St atistic al A n al ysis  
T he pri mar y e n d p oi nt c ha n ge fr o m baseli ne i n t he rati o of V h: Cd  will be a nal yze d usi n g a n 
a nal ysis of c o varia nce A N C O V A m o de l wit h treat me nt as a fact or a n d baseli ne as a 
c o variate.  Descri pti ve statistics will be use d i n ge neral t o s u m marize st u d y res ults, i e, 
statistics f or c o nti n u o us varia bles will i ncl u de n u m ber of o bser vati o ns , mea n, sta n dar d 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 2 0  
de viati o n, me dia n, first, sec o n d, a n d t hir d  q uartiles , mi ni m u m,  a n d ma xi m u m ; statistics f or 
bi nar y a n d cate g orical varia bles will i ncl u de c o u nt a n d perce nta ge . T he C V, G M will als o be 
i ncl u de d f or c o nti n u o us e n d p oi nts, w here a p pr o priate. 
Et hic al C o nsi der ati o ns :  
T he o verall p ote ntial be nefit/ris k of K A N -1 0 1 is c o nsi dere d fa v ora ble.  C o nsi deri n g  t he 
meas ures a n d miti gati o ns t o mi ni mize ris k t o st u d y partici pa nts, t he p ote ntial ris ks i de ntifie d 
i n ass ociati o n wit h  partici pati o n i n t he st u d y a n d wit h K A N -1 0 1  are j ustifie d b y t he 
a ntici pate d be nefits t hat ma y be aff or de d t o partici pa nts wit h Ce D.  
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

KAN-101
Protocol KAN-101-03
Final Protocol Amendment 01, 20 March 2024
CONFIDENTIAL
CT02-GSOP Clinical Protocol Template Phase 1 2 3 4 (14 April 2023)
Page 21
1.2. Schema
090177e1a041c2d5\Approved\Approved On: 22-Mar-2024 13:52 (GMT)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 2 2  
1. 3.  S c he d ule of Acti v ities 
T he S o A  ta ble pr o vi des a n o ver vie w of t he pr ot oc ol visits a n d pr oce d ures. Refer t o t he S T U D Y A S S E S S M E N T S A N D 
P R O C E D U R E S  secti o n of t he pr ot oc ol f or detaile d i nf or mati o n o n eac h pr oce d ure a n d assess me nt re q uire d f or c o m plia nce wit h t he 
pr ot oc ol.  
T he i n vesti gat or ma y sc he d ule visits ( u n pla n ne d visits) i n a d diti o n t o t h ose liste d in t he S o A  ta ble, i n or der t o c o n d uct e val uati o ns or 
assess me nts re q uire d t o pr otect t he well -bei n g of t he partici pa nt .  
T a ble 1 . 
Sc he d ule of Assess me nts  
A b bre viati o ns use d i n t his 
ta ble ma y be f o u n d i n 
A p pe n di x 1 2 . 
Scr . 
Tre at me nt 
Peri o d  
Gl ute n C h alle n ge  
( D a y 1 5 t o 2 8) 
Bi o ps y  F U  E T  
N otes  
Visit I de ntifier  
V 1  
V 2  V 3  V 4  V 5  
V 6  
V 7  
V 8  
V 9  E T  •  Da y relati ve t o start of st u d y i nter ve nti o n ( Da y  1).  
•  See Secti o n 8. 4. 3  f or f oll o w-u p A E a n d S A E assess me nts.  
•  D 1 6 a n d D 2 1 are p h o ne call visits  ( See Secti o n 8. 1. 1 ) f or 
c ollecti o n of A Es a n d  c o nc o mita nt me dicati o ns.  
T y pe ( Site or P h o ne C all)  
Site  Site  Site  Site  Site  P h o ne  P h o ne  
Site  
Site  Site  
St u d y D a y ( D)  
U p t o 
-4 2 
d a ys  
D 1  D 4  D 7  D 1 5  D 1 6  
D 2 1  
D 2 9  
D 4 2  E T  
Visit Wi n d o w ( d a ys)  
 
 
 
 
 
+ 2  
± 2  
+ 3  
+ 3  
 
 
Scree ni n g Assess me nts  
 
 
 
 
 
 
 
 
 
 
 
I nf or me d c o nse nt 
X  
 
 
 
 
 
 
 
 
 
•  I nf or me d c o nse nt s h o ul d be o btai ne d pri or t o u n der g oi n g a n y 
st u d y-s pecific pr oce d ures. See Secti o n 1 0. 1. 3  f or a d diti o nal 
i nf or mati o n. 
Me dical hist or y & 
de m o gra p hics  
X  
 
 
 
 
 
 
 
 
 
•  I ncl u des disease hist or y (s y m pt o ms at dia g n osis a n d le n gt h of ti me 
o n G F D) a n d G C hist or y ( wit hi n pre vi o us 1 2 m o nt hs).  
I ncl usi o n/e xcl usi o n  
X  
X  
 
 
 
 
 
 
 
 
 
HI V, H B V, H C V testi n g  
X  
 
 
 
 
 
 
 
 
 
•  See E xcl usi o n Criteri o n # 1 9  ( See A p pe n di x 2  f or a d diti o nal 
i nf or mati o n). 
H L A ge n ot y pe  
X  
 
 
 
 
 
 
 
 
 
•  
H L A ge n ot y pe will be assesse d via ce ntral la b orat or y. F or 
rescree ni n g, H L A d oes n ot nee d t o be re peate d. 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 2 3  
T a ble 1 . 
Sc he d ule of Assess me nts  
A b bre viati o ns use d i n t his 
ta ble ma y be f o u n d i n 
A p pe n di x 1 2 . 
Scr . 
Tre at me nt 
Peri o d  
Gl ute n C h alle n ge  
( D a y 1 5 t o 2 8) 
Bi o ps y  F U  E T  
N otes  
Visit I de ntifier  
V 1  
V 2  V 3  V 4  V 5  
V 6  
V 7  
V 8  
V 9  E T  •  Da y relati ve t o start of st u d y i nter ve nti o n ( Da y  1).  
•  See Secti o n 8. 4. 3  f or f oll o w-u p A E a n d S A E assess me nts.  
•  D 1 6 a n d D 2 1 are p h o ne call visits  ( See Secti o n 8. 1. 1 ) f or 
c ollecti o n of A Es a n d  c o nc o mita nt me dicati o ns.  
T y pe ( Site or P h o ne C all)  
Site  Site  Site  Site  Site  P h o ne  P h o ne  
Site  
Site  Site  
St u d y D a y ( D)  
U p t o 
-4 2 
d a ys  
D 1  D 4  D 7  D 1 5  D 1 6  
D 2 1  
D 2 9  
D 4 2  E T  
Visit Wi n d o w ( d a ys)  
 
 
 
 
 
+ 2  
± 2  
+ 3  
+ 3  
 
 
Ce D ser ol o g y  
X  
 
 
 
 
 
 
 
X  
X  •  Ce D ser ol o g y (t T G -I g A a n d D G P I g G) will be assesse d via ce ntral 
la b orat or y (see A p pe n di x 2  f or a d diti o nal i nf or mati o n). F or 
rescree ni n g, Ce D ser ol o g y o nl y nee ds t o be re peate d if > 3 m o nt hs 
ha ve ela pse d fr o m last assess me nt.   
1 2 -lea d E C G  
X  
 
 
 
 
 
 
 
 
 
•  N ot re q uire d f or partici pa nts w h o ha ve ha d a n E C G wit hi n 3 
m o nt hs  pri or t o scree ni n g.  
Set u p  e Diar y 
X  
 
 
 
 
 
 
 
 
 
 
Cli nic al Pr oce d ures  
 
 
 
 
 
 
 
 
 
 
 
P h ysical e xa mi nati o n  
X  
 
 
 
 
 
 
X  
X  
X  •  See Secti o n 8. 3. 5 . 
Pre g na nc y test  
X  
X  
 
 
X  
 
 
X  
X  
X  •  Test at scree ni n g m ust be ser u m; ser u m or uri ne tests are 
acce pta ble at ot her visits. Scree ni n g a n d pre -d osi n g pre g na nc y 
tests m ust be ne gati ve bef ore st u d y i nter ve nti o n is a d mi nistere d. 
D 1 5 pre g na nc y test m ust be ne gati ve bef ore 2 -wee k G C is 
i nitiate d. See Secti o n 8. 3. 6 .  
C o ntrace pti o n c hec k  
X  
X  
X  
X  
X  
 
 
X  
X  
X  •  See Secti o n 5. 3. 1  
Vital si g ns  
X  
X  
X  
X  
X  
 
 
X  
X  
X  
•  At scree ni n g o nl y, i ncl u des hei g ht a n d wei g ht.   
•  Vital si g ns ( p ulse rate, te m perat ure, res pirat or y rate, diast olic a n d 
s yst olic bl o o d press ure) s h o ul d be assesse d bef ore, d uri n g, a n d 
after d osi n g a n d bef ore sa m ple c ollecti o n . See Secti o n 8. 3. 2  f or 
a d diti o nal i nf or mati o n.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 2 4  
T a ble 1 . 
Sc he d ule of Assess me nts  
A b bre viati o ns use d i n t his 
ta ble ma y be f o u n d i n 
A p pe n di x 1 2 . 
Scr . 
Tre at me nt 
Peri o d  
Gl ute n C h alle n ge  
( D a y 1 5 t o 2 8) 
Bi o ps y  F U  E T  
N otes  
Visit I de ntifier  
V 1  
V 2  V 3  V 4  V 5  
V 6  
V 7  
V 8  
V 9  E T  •  Da y relati ve t o start of st u d y i nter ve nti o n ( Da y  1).  
•  See Secti o n 8. 4. 3  f or f oll o w-u p A E a n d S A E assess me nts.  
•  D 1 6 a n d D 2 1 are p h o ne call visits  ( See Secti o n 8. 1. 1 ) f or 
c ollecti o n of A Es a n d  c o nc o mita nt me dicati o ns.  
T y pe ( Site or P h o ne C all)  
Site  Site  Site  Site  Site  P h o ne  P h o ne  
Site  
Site  Site  
St u d y D a y ( D)  
U p t o 
-4 2 
d a ys  
D 1  D 4  D 7  D 1 5  D 1 6  
D 2 1  
D 2 9  
D 4 2  E T  
Visit Wi n d o w ( d a ys)  
 
 
 
 
 
+ 2  
± 2  
+ 3  
+ 3  
 
 
Pri or/c o n c o mita nt  
me ds/ pr oce d ures, 
i nci de ntal gl ute n e x p os ure 
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
•  See Secti o n 6. 9  f or a d diti o nal i nf or mati o n. 
•  I nci de ntal gl ute n e x p os ure c hec ke d dail y; e ntere d i nt o e Diar y a n d 
re vie we d at st u d y visits. 
E G D  wit h bi o ps y  
(a p pr o x. 6 d u o de nal 
bi o psies)  
X  
 
 
 
 
 
 
X  
 
X  
•  E G D s h o ul d o nl y be perf or me d after t he partici pa nt has q ualifie d 
wit h all ot her i ncl usi o n/e xcl usi o n criteria.  
•  F or rescree ni n g, E G D d oes n ot nee d t o be re peate d if  1)  < 3 m o nt hs 
ha ve ela pse d fr o m last scree ni n g assess me nt , 2) t he partici pa nt has 
c o nti n ue d G F D a n d 3) t he partici pa nt has n ot u n der g o ne a G C.   
•  O nl y partici pa nts w h o ha ve c o m plete d all 3 d oses of st u d y 
i nter ve nti o n a n d at least 7 da ys of G C s h o ul d u n der g o E G D wit h 
bi o ps y  at D 2 9 or at E T  visit  (if partici pa nt disc o nti n ues pri or t o 
D 2 9 ).  
P GI S  
 
X  
 
 
X  
 
 
X  
X  
X  
•  Da y 1 P GI S s h o ul d be c o m plete d pre -d ose (at least 5 mi n utes pri or 
t o i nf usi o n). 
P GI C  
 
 
 
 
X  
 
 
X  
X  
X  
 
G C  
 
 
 
 
D 1 5 -2 8 dail y  
 
 
 
•  G C c o m plete d i n cli nic o n D 1 5 a n d at h o me f or t he ne xt 1 3 da ys 
( D 1 6 t o D 2 8).  
•  Partici pa nts w h o wit h dra w fr o m treat me nt a n d d o n ot recei ve 3 f ull 
d oses s h o ul d n ot recei ve G C.  
C D S D  v 2. 1  
T o be c o m plete d d ail y 
•  P R O ( C D S D © v 2. 1) will be c o m plete d via e Diar y f or at least 7 
c o nsec uti ve da ys d uri n g scree ni n g.  
•  F or re -scree ni n g: C D S D v 2. 1 o nl y nee ds t o be re peate d if > 3 
m o nt hs ha ve ela pse d fr o m e n d of last P R O a d mi nistrati o n.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 2 5  
T a ble 1 . 
Sc he d ule of Assess me nts  
A b bre viati o ns use d i n t his 
ta ble ma y be f o u n d i n 
A p pe n di x 1 2 . 
Scr . 
Tre at me nt 
Peri o d  
Gl ute n C h alle n ge  
( D a y 1 5 t o 2 8) 
Bi o ps y  F U  E T  
N otes  
Visit I de ntifier  
V 1  
V 2  V 3  V 4  V 5  
V 6  
V 7  
V 8  
V 9  E T  •  Da y relati ve t o start of st u d y i nter ve nti o n ( Da y  1).  
•  See Secti o n 8. 4. 3  f or f oll o w-u p A E a n d S A E assess me nts.  
•  D 1 6 a n d D 2 1 are p h o ne call visits  ( See Secti o n 8. 1. 1 ) f or 
c ollecti o n of A Es a n d  c o nc o mita nt me dicati o ns.  
T y pe ( Site or P h o ne C all)  
Site  Site  Site  Site  Site  P h o ne  P h o ne  
Site  
Site  Site  
St u d y D a y ( D)  
U p t o 
-4 2 
d a ys  
D 1  D 4  D 7  D 1 5  D 1 6  
D 2 1  
D 2 9  
D 4 2  E T  
Visit Wi n d o w ( d a ys)  
 
 
 
 
 
+ 2  
± 2  
+ 3  
+ 3  
 
 
S afet y Assess me nts  
 
 
 
 
 
 
 
 
 
 
 
Seri o us a n d n o n -seri o us 
A E m o nit ori n g  
X  
X  
X  
X  
X  
X  
X  
X  
X  
X  
•  See Secti o n 8. 4  f or a d diti o nal i nf or mati o n. 
La b orat or y tests (safet y)  
X  
X  
X  
X  
X  
 
 
X  
X  
X  
•  I ncl u des he mat ol o g y, c he mistr y, uri nal y sis, a n d c oa g ulati o n. See 
A p pe n di x 2  f or a list of Cli nical La b orat or y tests t o be d o ne. F or 
c ollecti o n v ol u mes, see t he st u d y la b orat or y ma n ual.  
•  Da y 1, 4, & 7 c ollecti o n s h o ul d be d o ne pre -d ose (at least 5 mi n utes 
pri or t o i nf usi o n). Da y 1 5 c ollecti o ns s h o ul d be d o ne pri or t o t he 
G C.  
St u d y I nter ve nti o n 
A d mi nistr ati o n  a n d 
R a n d o miz ati o n  
 
 
 
 
 
 
 
 
 
 
•  
See Secti o n 6  f or a d diti o nal i nf or mati o n. 
Ra n d o mizati o n  
 
X  
 
 
 
 
 
 
 
 
 
St u d y I nter ve nti o n 
A d mi nistrati o n  
 
X  
X  
X  
 
 
 
 
 
 
•  See Secti o n 6. 1. 1 . Partici pa nts will be o bser ve d f or at least 4 h o urs 
i n cli nic f oll o wi n g I V i nf usi o n. 
A d diti o n al Bl o o d 
S a m ples  
 
 
 
 
 
 
 
 
 
 
 
P K bl o o d sa m ple  
 
X  
 
X  
 
 
 
 
 
 
•  P K sa m pli n g will be d o ne pre -d ose (at least 5 mi n utes pri or t o 
i nf usi o n) a n d e n d of i nf usi o n ( + 2) mi n utes. A d diti o nal sa m pli n g 
will be d o ne at 2. 5 h o urs ( ± 5 mi n utes) a n d 4 h o urs ( ± 5 mi n utes) 
after i nf usi o n start . 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 2 6  
T a ble 1 . 
Sc he d ule of Assess me nts  
A b bre viati o ns use d i n t his 
ta ble ma y be f o u n d i n 
A p pe n di x 1 2 . 
Scr . 
Tre at me nt 
Peri o d  
Gl ute n C h alle n ge  
( D a y 1 5 t o 2 8) 
Bi o ps y  F U  E T  
N otes  
Visit I de ntifier  
V 1  
V 2  V 3  V 4  V 5  
V 6  
V 7  
V 8  
V 9  E T  •  Da y relati ve t o start of st u d y i nter ve nti o n ( Da y  1).  
•  See Secti o n 8. 4. 3  f or f oll o w-u p A E a n d S A E assess me nts.  
•  D 1 6 a n d D 2 1 are p h o ne call visits  ( See Secti o n 8. 1. 1 ) f or 
c ollecti o n of A Es a n d  c o nc o mita nt me dicati o ns.  
T y pe ( Site or P h o ne C all)  
Site  Site  Site  Site  Site  P h o ne  P h o ne  
Site  
Site  Site  
St u d y D a y ( D)  
U p t o 
-4 2 
d a ys  
D 1  D 4  D 7  D 1 5  D 1 6  
D 2 1  
D 2 9  
D 4 2  E T  
Visit Wi n d o w ( d a ys)  
 
 
 
 
 
+ 2  
± 2  
+ 3  
+ 3  
 
 
A D A sa m ple  
 
X  
 
X  
 
 
 
X  
X  
X  
•  D 1 & D 7 sa m ples s h o ul d be ta ke n pre -d ose (at least 5 mi n utes 
pri or t o i nf usi o n).  
Plas ma bi o mar ker  
(i ncl u des I L-2)  sa m ple 
 
X  
X  
X  
X  
 
 
X  
X  
X  
•  See Secti o n 8. 2. 2  f or a d diti o nal i nf or mati o n. 
•  D 1,  D 4, a n d D 7 sa m ples s h o ul d be ta ke n pre -d ose (at least 5 
mi n utes pri or t o i nf usi o n) a n d 4 h o urs p ost e n d of i nf usi o n ± 1 5 
mi n utes. Da y 1 5 sa m ple s h o ul d be c ollecte d pri or t o G C a n d at 4 
h o urs ( ± 1 5 mi n utes) after G C.  
•  A si n gle sa m ple is c ollecte d o n D 2 9, D 4 2, a n d E T.  
•  Partici pa nts w h o wit h dra w fr o m treat me nt a n d d o n ot recei ve 3 f ull 
d oses s h o ul d n ot ha ve plas ma sa m ples c ollecte d  at D 1 5, D 2 9, a n d 
D 4 2 . 
A D A –  A nti -Dr u g A nti b o d y; A E –  A d verse E ve nt; C D S D –  Celiac Disease S y m pt o m Diar y; Ce D –  Celiac Disease; D - Da y; D G P I g G –  Dea mi date d Glia di n Pe pti de, I m m u n o gl o b uli n G; E C G –  
Electr ocar di o gra m ;e Diar y –  Electr o nic Diar y; E G D –  Es o p ha g o gastr o d u o de n osc o p y; E T –  Earl y Ter mi nati o n; F U –  F oll o w U p; G C –  Gl ute n C hall e n ge; G F D –  Gl ute n Free Diet; H B V –  He patitis B 
Vir us; H C V –  He p atitis C Vir us; HI V –  H u ma n I m m u n o deficie nc y Vir us; H L A –  H u ma n Le u k oc yte A nti ge ns; I L -2 –  I nterle u ki n-2;I V –  I ntra ve n o us; P GI C –  Patie nt Gl o bal I m pressi o n of C ha n ge; 
P GI S –  Patie nt Gl o bal I m pressi o n of Se verit y; P K –  P h ar mac o ki netics; P R O –  Patie nt Re p orte d O utc o me; S A E –  Seri o us A d verse E ve nt; Scr –  Scree ni n g; t T G, I g A –  Tiss ue Tra ns gl uta mi nase 
I m m u n o gl o b uli n A; V - Visit  
 
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 2 7  
2.  I N T R O D U C TI O N 
2. 1.  St u d y R ati o n ale  
T he s p o ns or is i nitiati n g t his P hase 2a st u d y of K A N -1 0 1 i n a d ult partici pa nts wit h Ce D t o 
i n vesti gate t he a bilit y of K A N-1 0 1 t o pr otect i ntesti nal m uc osa fr o m gl ute n -i n d uce d 
hist ol o gical da ma ge .  
2. 2.  B ac k gr o u n d  
2. 2. 1.  Celi ac Dise ase  
Ce D is a n i n herite d a ut oi m m u ne dis or der t hat affects t he di gesti ve pr ocess of t he s mall 
i ntesti ne. W he n a patie nt  wit h Ce D c o ns u mes gl ute n, t hat i n di vi d ual’s i m m u ne s yste m 
res p o n ds b y attac ki n g t he s mall i ntesti ne, t here b y i n hi biti n g t he a bs or pti o n of n utrie nts. Ce D 
ca n prese nt wit h a variet y of GI s y m pt o ms, i ncl u di n g diarr hea, bl oati n g, flat ule nce a n d 
a b d o mi nal pai n, a n d n o n -GI s y m pt o ms s uc h as a ne mia a n d vita mi n deficie ncies 
(Half da nars o n et al, 2 0 0 7 ; R u bi o -Ta pia et al, 2 0 1 3 ). U n dia g n ose d a n d u ntreate d Ce D has 
bee n li n ke d t o t he de vel o p me nt of ot her a ut oi m m u ne dis or ders, n utriti o nal dis or ders s uc h as 
oste o p or osis a n d i nfertilit y, a n d ne ur ol o gical c o n diti o ns (Gree n et al, 2 0 0 1 ; Gree n & Ja bri, 
2 0 0 6 ). 
It has bee n rece ntl y esti mate d t hat 0. 7 % of t he w orl d-wi de p o p ulati o n has Ce D, wit h gl o bal 
pre vale nce rates o n t he rise (Si n g h et al, 2 0 1 8 ). Ce D is str o n gl y ass ociate d wit h t he H u ma n 
Le u k oc yte A nti ge n ( H L A)-D Q A 1  a n d H L A -D Q B 1  l oci (H L A -1 * 0 5 , H L A -D Q B 1 * 0 2 ; 
c o m m o nl y referre d t o as H L A -D Q 2. 5) w hic h is prese nt i n a p pr o xi matel y 9 0 % of Ce D 
patie nts (S olli d et al, 1 9 8 9 ; S olli d et al, 2 0 1 2 ). T he pat h ol o g y o bser ve d i n Ce D patie nts is 
dri ve n b y t he a da pti ve i m m u ne res p o nse s pecific t o pr otei ns ge nerate d i n t he di gesti ve 
s yste m after i n gesti o n of gl ute n, w hic h res ults i n a ut oi m m u ne-li ke pat h ol o g y i n t he s mall 
i ntesti ne (S olli d & Ja bri, 2 0 1 3 ). Dia g n osis is t y picall y ma de b y a c o m bi nati o n of p ositi ve 
I g A, tT G , a n d/ or  I g G, D G Ps , a n d s mall i ntesti nal bi o ps y de m o nstrati n g vill o us a b n or malities 
w hile o n a gl ute n -c o ntai ni n g diet or f oll o wi n g a G C (Half da nars o n et al, 2 0 0 7 ; R u bi o -Ta pia 
et al, 2 0 1 3).  
T here is c urre ntl y n o p har mace utical treat me nt a p pr o ve d f or t he ma na ge me nt of Ce D. 
Patie nts ma na ge t heir s y m pt o ms b y strict a d here nce t o a G F D, w hic h ofte n prese nts a 
s u bsta ntial l o gistical a n d fi na ncial b ur de n (See et al, 2 0 1 5 ). T he effecti ve ness of t he G F D is 
li mite d n ot o nl y b y m oti vati o n, access, a n d e x pe nse, b ut b y u ncertai nt y relate d t o p ote ntial 
gl ute n c o nte nt of certai n me dicati o ns a n d s u p ple me nts. A d here nce t o t he strict G F D is als o 
li mite d b y t he u bi q uit y of gl ute n c o ntami nati o n i n ma n y gl ute n -free f o o ds. Se veral st u dies 
ha ve s h o w n i nc o m plete hist ol o gical n or malizati o n of s mall b o wel m uc osa des pite a strict 
G F D, wit h persiste nt vill o us atr o p h y see n i n u p t o 7 9 % of treate d patie nts (See et al, 2 0 1 5 ). 
I n a d diti o n t o a d here nce c halle n ges, s o me patie nts re p ort persiste nt, life-affecti n g s y m pt o ms 
des pite atte m pti n g t o a d here t o t he G F D. Patie nts wit h Ce D w h o a d here t o a strict G F D 
c o nti n ue t o ha ve a hea v y b ur de n of care.  
T h us, t here re mai ns a str o n g u n met me dical nee d f or p har mac ol o gic i nter ve nti o ns t o hel p 
alle viate t he gr o wi n g disease b ur de n of Ce D.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 2 8  
2. 2. 2.  K A N -1 0 1  
K A N -1 0 1  is c o m p ose d of a s y nt hetic li ver-tar geti n g 
 t o a 
s y nt hetic 
 pe pti de d o mai n of w heat al p ha glia di n ( K A N 0 0 0 9) rec o g nize d 
b y t he H L A -D Q 2. 5 ha pl ot y pe. K A N 0 0 0 9 d oes n ot bi n d t o t he H L A -D Q 8 m olec ule. K A N -
1 0 1 is a li q ui d f or m ulati o n dr u g pr o d uct a d mi nistere d pare nterall y via a n I V i nf usi o n . 
K A N -1 0 1 har nesses nat ural t oler o ge nic pat h wa ys i n t he li ver (T h o ms o n & K n olle, 2 0 1 0 ) t o 
re pr o gra m pat h o ge nic i m m u ne cells t o bec o me t olera nt t o war d s pecific a nti ge ns. K A N -1 0 1 
s pecificall y tar gets t he i m m u ne cells t hat dri ve Ce D a n d lea ves t he ot her wise healt h y 
c o m p o ne nts of t he i m m u ne s yste m i ntact t o perf or m t heir nat ural, pr otecti ve f u ncti o ns. T he 
pr o p ose d mec ha nis m of acti o n of K A N -1 0 1 is rece pt or -me diate d i nter nalizati o n of t he 
m olec ule i nt o li ver cells, a n d t he i n d ucti o n of i m m u ne t olera nce t hr o u g h s u bse q ue nt 
K A N 0 0 0 9 glia di n pe pti de a nti ge n prese ntati o n o n t he maj or hist oc o m pati bilit y c o m ple x 
( M H C; class I a n d II). After K A N-1 0 1 i nter nalizati o n i nt o li ver cells, t he K A N 0 0 0 9 pe pti de 
is release d fr o m t he G P p orti o n a n d pr ocesse d i ntracell ularl y f or prese ntati o n b y M H C a n d 
si g nali n g t o glia di n-s pecific T cells f or t he i n d ucti o n of i m m u ne t olera nce a n d s u bse q ue nt 
a meli orati o n of g ut pat h ol o g y.  
T he mec ha nis m s b y w hic h K A N -1 0 1 i n d uces i m m u n ol o gic t olera nce are me diate d b y:  
•  Deleti o n of a nti ge n -s pecific T cells 
•  I n d ucti o n of a ner g y/cl o nal e x ha usti o n of a nti ge n-s pecific T cells 
•  I n d ucti o n of re g ulat or y T cells w hic h c o ntr ol t he a nti ge n-s pecific T cell res p o nse. 
F or m ore i nf or mati o n o n t he n o ncli nical fi n di n gs, please see t he K A N -1 0 1 I B.  
2. 2. 3.  Cli nic al O ver vie w  
K A N -1 0 1 was e val uate d i n  a FI H P hase 1 st u d y i n partici pa nts  wit h Ce D  o n a G F D  
(K A N -1 0 1 -0 1 ). K A N -1 0 1 -0 1  was a 2 -part, m ultice nter st u d y desi g ne d t o e xa mi ne t he safet y 
a n d t olera bilit y  of S A D ( Part A) a n d M A D ( Part B) of K A N -1 0 1 . A t otal of 4 1  partici pa nts 
recei ve d at least 1 d ose of  K A N -1 0 1 ( 0. 1 5 m g/ k g, 0. 3 m g/ k g, 0. 6 m g/ k g, 1. 2 m g/ k g , a n d 1. 5 
m g/ k g ) d uri n g t he st u d y.  K A N -1 0 1 is als o c urre ntl y bei n g e val uate d i n a t w o-part P hase 
1 b/ P hase 2 st u d y ( K A N -1 0 1 -0 2).  
St u d y K A N -1 0 1 -0 1  
I n St u d y K A N-1 0 1 -0 1 a d mi nistrati o n of  K A N -1 0 1 was effecti ve at i n d uci n g T -cell t olera nce  
(M urra y et al, 2 0 2 3 ): 
•  T hree d oses of K A N -1 0 1, a d mi nistere d 3 da ys a part,  at 0. 1 5, 0. 3 a n d 0. 6 m g/ k g 
d ose le vels was effecti ve i n i n d uci n g T cell t olera nce t o glia di n. K A N -1 0 1 treate d 
partici pa nts e x hi bite d mi ni mal c ha n ge or a decrease i n t he glia di n -s pecific T-cell 
res p o nse f oll o wi n g G C w hile place b o patie nts e x hi bite d a n i ncrease i n t he 
glia di n -s pecific T-cell res p o nse f oll o wi n g G C.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)
C CI
C CI

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 2 9  
•   K A N -1 0 1 als o m o difie d t he i m me diate i m m u ne reacti o n u p o n i n gesti o n of gl ute n 
b y Ce D partici pa nts  i n a d ose-de pe n de nt ma n ner. Partici pa nts  treate d wit h 3 d oses 
of 0. 6 m g/ k g K A N -1 0 1, a d mi nistere d 3 da ys a part, e x hi bite d l o wer me dia n 
plas ma I L -2 le vels wit hi n h o urs of G C c o m pare d t o place b o or 0. 1 5 a n d 0. 3 
m g/ k g K A N -1 0 1 d ose le vels.  
K A N -1 0 1 de m o nstrate d a n acce pta ble safet y a n d t olera bilit y pr ofile after si n gle a n d m ulti ple 
d oses at all d ose le vels teste d  i n K A N-1 0 1 -0 1 . T here were n o deat hs, S A Es, or  Gra de 3  
T E A Es o bser ve d. T E A Es were c o nsiste nt wit h Ce D partici pa nts  u p o n gl ute n i n gesti o n (ie, 
na usea, e mesis, a b d o mi nal pai n, hea dac he, a n d diarr hea). N o cli nicall y rele va nt tre n ds were 
o bser ve d f or c ha n ges i n vital si g ns, p h ysical e xa mi nati o n, la b orat or y tests, or E C G res ults. 
T here were n o mea ni n gf ul c orrelati o ns bet we e n t he fre q ue nc y of T E A Es a n d st u d y dr u g d ose 
le vel. T here was a n i ncrease d fre q ue nc y of partici pa nts  w h o e x perie nce d GI A Es i n t he t otal 
dr u g -treate d gr o u p t ha n i n t he place b o gr o u p i n K A N-1 0 1 -0 1 . N o M T D of K A N-1 0 1 was 
i de ntifie d a n d n o mea ni n gf ul safet y differe nces were o bser ve d a m o n g treat me nt gr o u ps 
d uri n g t he st u d y.  
Data  fr o m t he K A N -1 0 1 -0 1  st u d y s u g gests ra pi d eli mi nati o n  wit h mea n  half -life ra n gi n g 
fr o m 3. 7 4 t o 3 6. 8 mi n utes acr oss 0. 1 5 m g/ k g t o 1. 2 m g/ k g d oses, f oll o wi n g si n gle or re peat 
I V i nf usi o ns of K A N-1 0 1 . T he mea n K A N -1 0 1 ma xi m u m e x p os ure ( C ma x ) a n d s yste mic 
e x p os ure ( A U C) a p peare d t o e x hi bit a p pr o xi mate d ose pr o p orti o nalit y acr oss 0. 1 5 t o 1. 2 
m g/ k g d ose ra n ge.  Wit h re peat d osi n g, t here was n o acc u m ulati o n of K A N -1 0 1 w hic h was i n 
c o nc or da nce wit h t he ra pi d eli mi nati o n.   
St u d y K A N -1 0 1 -0 2  
St u d y K A N -1 0 1 -0 2 is a n o n g oi n g, 2 -part st u d y t o e val uate t he safet y, t olera bilit y, P K 
para meters, a n d plas ma bi o mar ker (I L -2) res p o nse of partici pa nts wit h Ce D treate d wit h 
K A N -1 0 1. K A N -1 0 1 -0 2 Part A is a P hase 1 b, o pe n -la bel M A D st u d y t o e val uate safet y, 
t olera bilit y, a n d P K of t w o d oses of K A N-1 0 1, a d mi nistere d t hree da ys a part, at 1. 2 a n d 3. 0 
m g/ k g d ose le vels. Part B is a P hase 2, d o u ble -bli n d, P B O -c o ntr olle d parallel desi g n st u d y t o 
c haracterize t he bi o mar ker res p o nse i n peri p heral bl o o d f oll o wi n g G C. I n Part B , partici pa nts 
will be ra n d o mize d 1: 1: 1: 1 t o 4 treat me nt gr o u ps: P B O, 0. 6 m g/ k g, 1. 2 m g/ k g, or 3. 0 m g/ k g 
K A N -1 0 1.  
I n t he ori gi nal pr ot oc ol f or K A N -1 0 1 -0 2 , 1. 2 m g/ k g 3. 0 m g/ k g a n d 6. 0 m g/ k g K A N-1 0 1 
were pla n ne d t o be e val uate d i n a M A D 3 + 3 desi g n ( Part A). Base d u p o n e mer gi n g data fr o m 
Part A  re vie we d b y t he K A N-1 0 1 -0 2  i n de pe n de nt D S M B , t he pr ot oc ol was a me n de d 
( A me n d me nt 1) t o pr ocee d t o Part B f oll o wi n g c o m pleti o n of t he Part A 3. 0 m g/ k g d ose 
c o h ort. T he decisi o n n ot t o test 6. 0 m g/ k g was n ot d ue t o a n y safet y c o ncer ns or e x p os ures 
w hic h e xcee de d t he N O A E L. Part B is o n g oi n g a n d will e val uate 0. 6 m g/ k g, a n d 1. 2 m g/ k g,  
a n d 3. 0 m g/ k g will be e val uate d i n a d ose -ra n gi n g desi g n ( Part B) i n Ce D partici pa nts o n 
G F D.  
F or m ore i nf or mati o n o n t he n o ncli nical a n d pre vi o us cli nical fi n di n gs, please see t he 
K A N -1 0 1 I B.   
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 3 0  
Base d o n n o ncli nical a n d cli nical fi n di n gs fr o m t he FI H st u d y ( K A N -1 0 1 -0 1), as well as  
i n de pe n de nt D S M B re vie we d preli mi nar y data fr o m t he o n g oi n g P h ase 1 b/ 2 st u d y i n a d ults 
wit h Ce D ( K A N -1 0 1 -0 2), t he s p o ns or is i nitiati n g t his P hase 2a st u d y of K A N -1 0 1 i n a d ult 
partici pa nts wit h Ce D t o i n vesti gate t he a bilit y of K A N -1 0 1 t o pr otect i ntesti nal m uc osa fr o m 
gl ute n -i n d uce d hist ol o gical da ma ge .  
2. 3.  Be nefit/ Ris k Assess me nt  
M ore detaile d i nf or mati o n a b o ut t he k n o w n a n d e x pecte d be nefits a n d ris ks a n d reas o na bl y 
e x pecte d A Es  of  K A N -1 0 1  is f o u n d i n t he I B, w hic h c o ntai ns t he R SI, w hic h is t he S R S D f or 
t his st u d y. Refer t o t he St u d y I nter ve nti o n(s) ta ble i n Secti o n 6. 1  f or a c o m plete descri pti o n 
of S R S Ds .
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 3 1  
2. 3. 1.  Ris k Assess me nt  
P ote nti al Ris k of Cli nic al Si g nific a nce  
S u m m ar y of D at a/ R ati o n ale f or 
Ris k  
Miti g ati o n Str ate g y  
St u d y I nter ve nti o n(s) [ K A N-1 0 1  a n d pl ace b o ]  
 
P ote ntial f or e xacer bati o n of gastr oi ntesti nal s y m pt o ms ass ociate d wit h 
Ce D, w hic h ma y i ncl u de a n d are n ot necessaril y li mite d t o A Es  of 
hea dac he, dizzi ness, fati g ue/let har g y, na usea, v o miti n g, a b d o mi nal pai n, 
diarr hea, c o nsti pati o n, s ki n ras h, a n d a b d o mi nal te n der ness.  
T he p ote ntial ris ks are base d o n t he 
mec ha nis m of acti o n of K A N -1 0 1 a n d 
ot her si milar t hera pe utic 
i n vesti gati o nal i m m u n o m o d ulat or y 
t hera pies i n Ce D (Da ves o n et al, 
2 0 1 7 ; Tr uitt et al, 2 0 1 9 ). 
A Es a n d cli nical la b orat or y res ults 
will be m o nit ore d o n a n o n g oi n g basis  
a n d ma na ge d acc or di n g t o esta blis he d 
sta n dar d of care. 
Use of a place b o ar m.  
T he use of a place b o re prese nts a 
p ote ntial ris k.  
Partici pa nts w h o e x perie nce 
w orse ni n g  of Ce D ma y disc o nti n ue 
fr o m t he st u d y a n d ma y recei ve 
sta n dar d of care treat me nt at t he 
i n vesti gat or’s discreti o n. 
I V i nf usi o ns will be a d mi nistere d o ver 3 0 mi n utes  e ver y 3 da ys d uri n g 
st u d y treat me nt peri o d. 
I R R are k n o w n ris ks ass ociate d wit h 
I V i nf usi o ns. 
IR R  will be m o nit ore d a n d s pecific 
g ui da nce o n ac ute a n d pr o p h ylactic 
treat me nt of I R Rs a n d 
rec o m me n dati o ns f or f ut ure i nf usi o ns 
of K A N -1 0 1 are pr o vi de d i n 
A p pe n di x  9 .  
P ote ntial h y perse nsiti vit y reacti o ns ma y occ ur a n d i ncl u de s ki n reacti o n, 
m uc osal tiss ue reacti o n, res pirat or y reacti o n, GI reacti o ns, a n d C V 
reacti o ns.  
Si milar t o ot her bi ol o gic m olec ules.  
Partici pa nts will be cl osel y m o nit ore d 
o n site f or 4 h o urs p ost i nf usi o n  f or 
si g ns of a n y reacti o n. 
K A N -1 0 1  is a li ver tar geti n g a ge nt. 
Alt h o u g h FI H St u d y K A N -1 0 1 -0 1 
a n d n o ncli nical data s h o w t hat K A N -
1 0 1 ha d n o si g nifica nt i m pact o n t he 
li ver (e g, li ver e nz y me le vels a n d 
hist o pat h ol o g y). K A N -1 0 1 ’s p ote ntial 
i m pact o n li ver e nz y mes a n d bilir u bi n  
will c o nti n ue t o be e val uate d  i n t he 
cli nical setti n g.  
Tra nsa mi nase , A L P a n d t otal bilir u bi n 
le vels will be cl osel y m o nit ore d a n d 
are i ncl u de d i n safet y la b orat or y 
assess me nts. Partici pa nts wit h A L T, 
A S T, or A L P > 1. 5 × U L N are n ot 
eli gi ble f or e nr oll me nt i n K A N -1 0 1 -
0 3 .  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 3 2  
P ote nti al Ris k of Cli nic al Si g nific a nce  
S u m m ar y of D at a/ R ati o n ale f or 
Ris k  
Miti g ati o n Str ate g y  
Partici pa nts c o nsi dere d t o ha ve a 
p ote ntial case of H y’s la w will lea d t o 
a cessati o n of cli nical d osi n g a n d 
partici pa nt will be f oll o we d t o 
res ol uti o n.  
St u d y Pr oce d ures  
K A N -1 0 1 -0 3  i ncl u des a m ulti ple -da y  ( Da y 1 5 -2 8 dail y) G C c o mprisi n g 
i n gesti o n of 9 g/ da y of gl ute n pr otei n.  
K n o w n A Es ass ociate d wit h G C are 
e x pecte d, w hic h ma y i ncl u de a n d are 
n ot necessaril y li mite d t o A Es of 
hea dac he, fati g ue/let har g y, na usea, 
v o miti n g, a b d o mi nal pai n, diarr hea, 
c o nsti pati o n, a n d s ki n ras h. 
Hist ol o gical da ma ge will occ ur as a 
res ult of t he pr ol o n ge d G C a n d c o ul d 
res ult i n altere d a bs or pti o n of 
n utrie nts or fl ui ds . S y m pt o ms of s uc h 
da ma ge c o ul d i ncl u de  diarr hea, 
wei g ht l oss, a n d ir o n deficie nc y 
a ne mia. 
Partici pa nts will c o ns u me t he G C i n 
cli nic o n Da y 1 5 a n d at h o me f or t he 
re mai n 1 3 da ys t hr o u g h Da y 2 8 a n d 
will be m o nit ore d f or A Es ass ociate d 
wit h G C  a n d ma na ge d acc or di n g t o 
esta blis he d sta n dar d of care .  
T he hist ol o gical da ma ge d oes n ot 
persist l o n g -ter m a n d is re verse d u p o n 
G F D . Partici pa nts will be m o nit ore d 
f or A Es, i ncl u di n g s y m pt o ms of Ce D 
a n d i ntesti nal m uc osal da ma ge , a n d 
safet y la bs will be assesse d 
t hr o u g h o ut t he st u d y t o i de ntif y a n y 
a b n or malities t hat ma y occ ur.  
K A N -1 0 1 -0 3 i ncl u des 2 E G D  wit h bi o ps y  ( Scree ni n g a n d Da y 29 ).  
E G D wit h bi o ps y carries a s mall ris k 
of b o wel perf orati o n.  D u o de nal 
bi o psies als o carr y t he ris k of 
d u o de nal he mat o ma.  
E G D  f or t he st u d y will be perf or me d 
b y q ualifie d a n d e x perie nce d 
gastr oe nter ol o gists . 
Ot her  
T he C O VI D -1 9 pa n de mic ma y p ose ris ks t o st u d y partici pati o n.  
Partici pa nts ma y ha ve i ncrease d ris k 
of S A R S -C o V -2 i nfecti o n b y 
u n der g oi n g a st u d y pr oce d ure at a 
st u d y facilit y. 
I ncl usi o n of C O VI D-1 9 s pecific 
scree ni n g pr oce d ures a n d assess me nts 
acc or di n g t o t he S o A . 
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 3 3  
2. 3. 2.  Be nefit Assess me nt  
T here is n o i n di vi d ual healt h be nefit f or partici pati n g i n t he st u d y. H o we ver, p artici pa nts 
c o ntri b ute t o t he pr ocess of de vel o pi n g ne w t hera pies f or Ce D f or w hic h t here re mai ns a 
str o n g u n met me dical nee d f or p har mac ol o gic i nter ve nti o ns to  hel p alle viate t he gr o wi n g 
disease b ur de n . 
2. 3. 3.  O ver all Be nefit /Ris k C o ncl usi o n  
T he o verall  p ote ntial be nefit/ris k of K A N -1 0 1 is c o nsi dere d fa v ora ble.   
C o nsi deri n g  t he meas ures a n d miti gati o ns t o mi ni mize ris k t o st u d y partici pa nts , t he p ote ntial 
ris ks, i ncl u di n g t he use of a place b o ar m, i de ntifie d i n ass ociati o n wit h  partici pati o n i n t he 
st u d y a n d wit h K A N -1 0 1  are j ustifie d b y t he a ntici pate d be nefits t hat ma y be aff or de d t o 
partici pa nts wit h Ce D .  
3.  O B J E C TI V E S, E N D P OI N T S, A N D E S TI M A N D S  
O bjecti ves  
E n d p oi nts  
Esti m a n ds  
Pri m ar y:  
Pri m ar y:  
Pri m ar y:  
•  
Assess t he a bilit y of K A N -1 0 1 t o 
atte n uate G C -i n d uce d c ha n ges i n 
d u o de nal hist ol o g y as meas ure d 
b y c ha n ges i n V h: C d rati o after a 
2 -wee k G C.  
•  
C ha n ges  fr o m baseli ne i n 
V h: C d  rati o as assesse d b y 
E G D wit h bi o ps y after 2 -
wee k G C (at Da y 2 9).  
Esti m a n d 1:  T he pri mar y esti ma n d is t he 
h y p ot hetical esti ma n d, w hic h esti mates t he 
treat me nt effect of K A N-1 0 1 vs Place b o f or 
c ha n ge fr o m baseli ne i n V h: C d u n der t he 
sce nari o of n o i nterc urre nt e ve nts. It 
i ncl u des t he f oll o wi n g 5 attri b utes: 
•  
P o p ulati o n : Partici pa nts w h o 
recei ve all 3 d oses of st u d y 
i nter ve nti o n a n d c o m plete at least 7 
da ys of G C.  
•  
Varia ble : t he rati o of V h: C d c ha n ge 
fr o m baseli ne at Da y 2 9. 
•  
Treat me nt c o n diti o ns : K A N-1 0 1 or 
place b o.  
•  
I nterc urre nt E ve nts: Pr o hi bite d 
me dicati o n. All data c ollecte d after 
a n y i nterc urre nt e ve nts will be 
e xcl u de d.  
•  
P o p ulati o n le vel s u m mar y: T he 
L S M differe nce of t he c ha n ge fr o m 
baseli ne i n V h: C d bet wee n K A N -
1 0 1 a n d place b o.  
Sec o n d ar y:  
Sec o n d ar y:  
Sec o n d ar y:  
•  
E xa mi ne t he i m pact of K A N -1 0 1 
o n bi o mar ker res p o nse (I L -2) i n 
peri p heral bl o o d f oll o wi n g G C  
•  
I L-2 c ha n ge fr o m Da y 1 5 
(first da y of G C) pre G C t o 
Da y 1 5 p ost G C  
Esti m a n d 2  is t he h y p ot hetical esti ma n d, 
w hic h esti mates t he treat me nt effect of 
K A N -1 0 1 vs Place b o f or I L -2 u n der t he 
sce nari o of n o i nterc urre nt e ve nts. It 
i ncl u des t he f oll o wi n g 5 attri b utes: 
•  
P o p ulati o n : Partici pa nts w h o 
c o m plete all 3 d oses of st u d y 
i nter ve nti o n a n d c o m plete at least 
7 da ys of G C.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 3 4  
O bjecti ves  
E n d p oi nts  
Esti m a n ds  
•  
Varia ble : l o g tra nsf or me d I L-2 
c ha n ge fr o m pre G C t o p ost G C at 
Da y 1 5.  
•  
Treat me nt c o n diti o ns : K A N-1 0 1 
or Place b o.  
•  
I nterc urre nt E ve nts: Pr o hi bite d 
me dicati o n, i nc o m plete G C o n 
Da y 1 5. All data c ollecte d after 
a n y i nterc urre nt e ve nts will be 
e xcl u de d.  
•  
P o p ulati o n le vel s u m mar y: T he 
L S M differe nce of t he c ha n ge 
fr o m pre G C t o p ost G C at Da y 1 5 
(l o g tra nsf or me d) bet wee n K A N-
1 0 1 a n d place b o.  
•  Deter mi ne t he effects of K A N -
1 0 1 o n hist ol o gic feat ures (I E Ls 
de nsit y) i n d u o de n u m bi o psies 
f oll o wi n g 2-wee k G C.  
•  
C ha n ges fr o m baseli ne i n 
I E L de nsit y i n d u o de n u m 
bi o ps y after 2 -wee k G C  (at 
Da y 2 9)  
Esti m a n d 3 is t he h y p ot hetical esti ma n d, 
w hic h esti mates t he treat me nt effect of 
K A N -1 0 1 vs place b o f or c ha n ge fr o m 
baseli ne i n d u o de nal I E L de nsit y u n der t he 
sce nari o of n o i nterc urre nt e ve nts. It 
i ncl u des t he f oll o wi n g 5 attri b utes: 
•  
P o p ulati o n : Partici pa nts w h o 
c o m plete all 3 d oses of st u d y 
i nter ve nti o n a n d c o m plete at least 
7 da ys of G C.  
•  
Varia ble : I E L c ha n ge fr o m 
baseli ne  at Da y 2 9. 
•  
Treat me nt c o n diti o ns : K A N-1 0 1 
or place b o.  
•  
I nterc urre nt E ve nts: Pr o hi bite d 
me dicati o n. All data c ollecte d 
after a n y i nterc urre nt e ve nts will 
be e xcl u de d.  
•  
P o p ulati o n le vel s u m mar y: T he 
L S M differe nce of t he c ha n ge 
fr o m baseli ne i n I E L bet wee n 
K A N -1 0 1 a n d place b o.  
 
•  
Assess t he safet y a n d t olera bilit y 
of K A N -1 0 1 i n partici pa nts wit h 
Ce D.  
•  
I nci de nce a n d se verit y of 
treat me nt e mer ge nt A Es as 
assesse d b y t he C T C A E v 6. 0 
( or hi g her) 
N ot a p plica ble.  
•  
I nci de nce a n d titer of K A N-
1 0 1 A D A.  
N ot a p plica ble. 
•  
Assess t he P K of m ulti ple d oses 
of K A N -1 0 1 i n partici pa nts wit h 
Ce D.  
•  
Plas ma c o nce ntrati o n of 
K A N -1 0 1, a n d ass ociate d 
K A N -1 0 1 para meters: 
A U Ci nf, A U Clast, C ma x, 
T ma x a n d t ½  
N ot a p plica ble.  
Terti ar y/ E x pl or at or y:  
Terti ar y/ E x pl or at or y:  
Terti ar y/ E x pl or at or y:  
•  
E val uate c ha n ges i n hist ol o gical 
feat ures ( Mars h-O ber h u ber 
sc ore) after a 2-wee k G C  
•  
C ha n ges fr o m baseli ne i n 
Mars h -O ber h u ber sc ore 
assesse d via E G D wit h 
bi o ps y after 2 -wee k G C  
N ot a p plica ble.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 3 5  
O bjecti ves  
E n d p oi nts  
Esti m a n ds  
•  
Assess t he i m pact of K A N-1 0 1 
a d mi nistrati o n o n t he i nci de nce 
of Ce D s y m pt o ms bef ore a n d 
d uri n g G C as meas ure d usi n g 
C D S D v 2. 1.  
•  
C ha n ges fr o m baseli ne i n 
s y m pt o ms P R Os i ncl u di n g: 
C D S D v 2. 1, P GI C a n d P GI S 
o ver ti me.  
N ot a p plica ble.  
•  
Assess w het her K A N -1 0 1 affects 
t he i nci de nce a n d/ or titer of p ost-
G C celiac ser ol o g y.  
•  
I nci de nce a n d titer of t T G 
I g A a n d D G P I g G at Da y 4 2. 
N ot a p plica ble.  
 
4.  S T U D Y D E SI G N  
4. 1.  O ver all Desi g n  
St u d y K A N -1 0 1 -0 3 is a m ulti -ce nter, d o u ble -bli n d, place b o -c o ntr olle d P hase 2a st u d y t o 
e xa mi ne w het her K A N -1 0 1 c o nfers pr otecti o n fr o m G C -i n d uce d hist ol o gical  c ha n ges i n t he 
d u o de n u m  a n d t o f urt her e val uate t he safet y/t olera bilit y of K A N -1 0 1 i n a d ult partici pa nts  
≥1 8 years  t o 7 0 years wit h Ce D. Fift y -t w o partici pa nts  ( 2 6 partici pa nts  per ar m) will be 
ra n d o mize d 1: 1 t o t he f oll o wi n g ar ms:  
1.  0 . 6 m g/ k g K A N -1 0 1 ( Ar m 1)  
2.  Place b o ( Ar m 2 ) 
Ka n y os Bi o , I nc. a w h olly o w ne d s u bsi diar y of A n o ki o n , as t he sp o ns or of t he st u d y, is 
dele gati n g t o Pfizer all o bli gati o ns f or c o n d uct of St u d y, i ncl u di n g res p o nsi bilit y f or 
pre pari n g t he pr ot oc ol, a n d o verall c o n d uct a n d o versi g ht of t he st u d y, i ncl u di n g c o ntracti n g 
wit h st u d y sites.  F or t his st u d y, a D S M B (see Secti o n 1 0. 1. 5 ) will re vie w c u m ulati ve safet y 
data . 
T his st u d y  c o m prises 4 peri o ds :  
•  Scree ni n g peri o d:  u p t o ≤4 2 da ys  bef ore treat me nt i nitiati o n 
•  D uri n g t he scree ni n g peri o d, eli gi bilit y will be c o nfir me d b y E G D wit h 
d u o de nal bi o ps y. T he E G D wit h bi o ps y will o nl y be perf or me d o nce all ot her 
i ncl usi o n criteria are f ulfille d. Hist ol o g y res ults m ust be recei ve d pri or t o 
d osi n g t o c o nfir m eli gi bilit y.  
•  Tre at me nt  peri o d:  T he st u d y treat me nt peri o d is 7 da ys ( Da y 1 t o Da y 7). St u d y 
i nter ve nti o n (eit her K A N-1 0 1 or place b o) will be a d mi nistere d t o e nr olle d 
partici pa nts i n t he cli nic I V o n  Da ys 1, 4, a n d 7.  P ost i nf usi o n eac h treat me nt da y, 
partici pa nts will be m o nit ore d i n t he cli nic f or at least 4 h o urs f or a d verse 
reacti o ns. 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 3 6  
•  Gl ute n  C h alle n g e ( G C): 1 4 da ys  
•  Partici pa nts will u n der g o a 2 -wee k G C i n w hic h t he y will i n gest 9  g /da y 
of gl ute n pr otei n i n t he f or m of 1 2 g vital w heat gl ute n. All partici pa nts 
will ret ur n t o t he cli nic  Da y 1 5 f or t he first da y of t he G C. T he Da y 1 5 G C 
will be perf or me d i n t he cli nic u n der s u per visi o n a n d bl o o d sa m ples will 
be c ollecte d at least 5 mi n utes pri or t o G C a n d 4 h o urs after t he 
c o m pleti o n of t he Da y 1 5 G C f or bi o mar ker assess me nt. Materials wi ll be 
se nt h o me wit h t he partici pa nt t o c o m plete t he dail y G C f or t he ne xt 2 
wee ks  (t hr o u g h Da y 2 8). T he st u d y site will call t he partici pa nt o n Da y 1 6 
a n d Da y 2 1 t o c ollect data o n a n y A Es a n d/or C M o ver t he tele p h o ne. 
S y m pt o m m o nit ori n g will be c o n d ucte d via t he e Diar y.   
•  O bser v ati o n /foll o w -u p peri o d:  Partici pa nts will be f oll o we d f or safet y f or 4 2 
da ys ( Da y 1 t o Da y 4 2). T he sec o n d E G D wit h d u o de nal bi o ps y will be c o n d ucte d 
o n Da y 2 9. Partici pa nts will ret ur n t o t he cli nic o n Da y 4 2 f or a fi nal f oll o w -u p 
visit i ncl u di n g safet y assess me nt a n d la bs, celiac ser ol o g y, a n d e x pl orat or y 
bi o mar ker sa m ple c ollecti o ns. See S o A  f or assess me nts t o be perf or me d at t his 
visit.  
Refer t o Ta ble 1  f or t he c o m plete sc he d ule of assess me nts. If partici pa nts are u na ble t o ret ur n 
t o t he cli nic f or pr ot oc ol-s pecifie d visits, alter nati ve met h o ds f or safet y assess me nts a n d data 
c ollecti o n ma y be e m pl o ye d t o e ns ure t he safet y of t he trial partici pa nts w he n a p pr o priate.  
A n i nteri m a nal ysis ma y be perf or me d  w he n a p pr o xi matel y 1 3 e val ua ble partici pa nts fr o m 
eac h gr o u p ha ve c o m plete d t he Da y 2 9 visit a n d hist ol o g y assess me nts. F urt her details a n d 
st u d y st o p pi n g criteria are prese nte d i n Secti o n 9. 5 . 
4. 2.  Scie ntific R ati o n ale f or  St u d y Desi g n  
Base d o n n o ncli nical a n d cli nical fi n di n gs fr o m t he FI H st u d y ( K A N -1 0 1 -0 1), t he s p o ns or is 
i nitiati n g t his P hase 2a st u d y of K A N-1 0 1 i n a d ult partici pa nts wit h Ce D t o i n vesti gate t he 
a bilit y of K A N-1 0 1 t o pr otect i ntesti nal m uc osa fr o m gl ute n -i n d uce d hist ol o gical da ma ge.   
4. 2. 1.  C h oice of C o ntr ace pti o n/ B arrier Re q uire me nts  
K A N -1 0 1 has n ot bee n e val uate d  i n E F D  st u d y. T he effects of K A N -1 0 1 o n c o nce pti o n, 
pre g na nc y,  a n d lactati o n are u n k n o w n. T heref ore, t he use of a hi g hl y effecti ve c o ntrace pti o n 
is re q uire d f or W O C B P , a n d all me n w h o are n ot sterile ( bi ol o gicall y or s ur gicall y) m ust 
c o m mit t o t he use of 1  relia ble met h o d of birt h c o ntr ol f or at least 21  da ys after t he last d ose 
of st u d y i nter ve nti o n  (see A p pe n di x 4  f or f urt her i nf or mati o n).  
T he o bser ve d t 1/ 2 of K A N -1 0 1 ra n ges bet wee n 3. 7 4 t o 3 6. 8 mi n utes acr oss 0. 1 5 m g/ k g t o 1 .5  
m g/ k g d oses wit h n o acc u m ulati o n o bser ve d f or re peat d osi n g.  Pre -cli nical t o xic ol o g y a n d 
cli nical  i nf or mati o n f or K A N-1 0 1  are s u m marize d i n  t he I B. 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 3 7  
4. 3.  J ustific ati o n f or D ose  
T he pr o p ose d d ose of K A N -1 0 1 is 0. 6 m g/ k g a d mi nistere d i n 3 d oses 3 da ys a part. T he 
n o ncli nical E x peri me ntal A ut oi m m u ne  E nce p hal o m yelitis ( E A E)  m o use m o del als o 
de m o nstrate d t hat d osi n g e ver y 3 da ys was si g nifica ntl y m ore effecti ve i n i n d uci n g t olera nce 
a n d i m pr o vi n g disease o utc o me t ha n 3 d oses a d mi nistere d wee kl y, or 3 d oses a d mi nis tere d 
dail y.  W hile K A N -1 0 1 is e x pecte d t o be ra pi dl y distri b ute d fr o m t he bl o o dstrea m i nt o t he 
li ver, w hic h is t he tar get or ga n, it a p pears t o ha ve fast cleara nce a n d lac k of 
acc u m ulati o n  after e x p os ure i n plas ma/ser u m i n precli nical a n d cli nical st u dies. T he 0. 6 
m g/ k g a d mi nistere d i n 3 d oses 3 da ys a part i n t he FI H K A N -1 0 1 -0 1 st u d y has bee n 
esta blis he d t o be safe a n d t olera ble. T he cli nical efficac y bi o mar ker data fr o m t he st u d y 
K A N -1 0 1 -0 1  st u d y f urt her s u p p orts t his d osi n g re gi me n si nce plas ma i nfla m mat or y I L -2 
bi o mar ker le vels after gl ute n c halle n ge were l o wer i n t he 0. 6 m g/ k g d ose gr o u p ( w he n 
c o m pare d wit h place b o) at all ti me p oi nts e xa mi ne d o n D 1 5.  
T he E A E m o del is a n i nfla m mat or y a n d de m yeli nati n g disease m o del t hat reca pit ulates 
h u ma n m ulti ple scler osis pat h ol o g y. E A E was c h ose n d ue t o a lac k of a vaila ble celiac 
disease m o dels. T he E A E m o del data de m o nstrate d t hat d osi n g e ver y 3 da ys was m ore 
effec ti ve t ha n wee kl y d osi n g, a n d it was als o deter mi ne d t hat 3 d oses a d mi nistere d e ver y 3 
da ys were si g nifica ntl y m ore effecti ve i n i n d uci n g t olera nce a n d i m pr o vi n g disease o utc o me 
t ha n 3 d oses a d mi nistere d wee kl y, or 3 d oses a d mi nistere d dail y. T his d osi n g fre q ue nc y is 
f urt her s u p p orte d b y t he cli nical efficac y bi o mar ker data fr o m t he FI H st u d y K A N-1 0 1 -0 1 
w here plas ma i nfla m mat or y I L -2 bi o mar ker le vels were m o nit ore d  bef ore a n d after gl ute n 
c halle n ge f or d ose a n d place b o gr o u ps. T he  data  s h o we d t hat plas ma I L -2 le vels o bser ve d 
after gl ute n c halle n ge were l o wer i n t he 0. 6 m g/ k g d ose gr o u p c o m pare d wit h  place b o at all 
ti me p oi nts e xa mi ne d o n D 1 5. Fi nall y, K A N-1 0 1 is ra pi dl y distri b ute d fr o m t he bl o o dstrea m 
i nt o t he li ver; ser u m a n d plas ma c o nce ntrati o ns are u n detecta ble wit hi n 1 t o 4 h o urs of d ose 
a d mi nistrati o n i n rats a n d c y n o m ol g us m o n ke ys. T he half -life o bser ve d i n t he FI H st u d y 
K A N -1 0 1 -0 1 was o n t he or der of 3 0 mi n utes. T here is n o e vi de nce of acc u m ulati o n wit h 
re peate d d osi n g i n eit her precli nical or cli nical st u dies. 
T he d oses teste d i n FI H K A N -1 0 1 -0 1 st u d y were 0. 3, 0. 6, a n d 1. 2 m g/ k g a n d n o safet y 
si g nals were o bser ve d. A d diti o nall y, t he hi g hest d ose teste d i n t he o n g oi n g K A N-1 0 1 -0 2 
st u d y is 3 m g/ k g a n d n o safet y si g nals ha ve bee n o bser ve d. T he d ose pr o p ose d f or t his st u d y 
is 0. 6 m g/k g  a d mi nistere d  i n 3 d oses 3 da ys a part. 
4. 4.  E n d of St u d y Defi niti o n  
T he e n d of t he st u d y is defi ne d as t he date of  the last visit of t he last partici pa nt i n t he st u d y 
or last sc he d ule d pr oce d ure s h o w n i n t he S o A  f or t he last partici pa nt i n t he trial gl o ball y. 
A partici pa nt is c o nsi dere d t o ha ve c o m plete d t he st u d y if t he y ha ve c o m plete d all peri o ds of 
t he st u d y, i ncl u di n g t he last visit or t he last sc he d ule d pr oce d ure s h o w n i n t he S o A . 
5.  S T U D Y P O P U L A TI O N  
T his st u d y ca n f ulfill its o bjecti ves o nl y if a p pr o priate partici pa nt s are e nr olle d, i ncl u di n g 
partici pa nts acr oss di verse a n d re prese ntati ve racial a n d et h nic bac k gr o u n ds. If a 
prescree n i n g t o ol is utilize d f or st u d y recr uit me nt p ur p oses, it will i ncl u de c ollecti o n of 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 3 8  
i nf or mati o n t hat reflects t he e nr oll me nt of a di verse partici pa nt p o p ulati o n i ncl u di n g, w here 
per mitte d u n der l ocal re g ulati o ns, a ge, se x, race, a n d et h nicit y . T he f oll o wi n g eli gi bilit y 
criteria are desi g ne d t o select partici pa nt s f or w h o m partici pati o n i n t he st u d y is c o nsi dere d 
a p pr o priate. All rele va nt me dical a n d n o n me dical c o n diti o ns s h o ul d be ta ke n i nt o 
c o nsi derati o n w he n deci di n g w het her a partic ular partici pa nt  is s uita ble f or t his pr ot oc ol.  
Pr os pecti ve a p pr o val of pr ot oc ol de viati o ns t o recr uit me nt a n d e nr oll me nt criteria , als o 
k n o w n as pr ot oc ol wai vers or e xe m pti o ns, is n ot per mitte d. 
5. 1.  I ncl usi o n Criteri a 
Partici pa nts are eli gi ble t o be i ncl u de d i n t he st u d y o nl y if all of t he f oll o wi n g criteria a p pl y:  
A ge  a n d Se x : 
1.  P artici pa nts  a ge d 1 8  years t o 7 0 i ncl usi ve ( or t he mi ni m u m a ge of c o nse nt i n 
acc or da nce wit h l ocal re g ulati o ns) at scree ni n g.   
•  Refer t o A p pe n di x 4  f or re pr o d ucti ve criteria f or male (Secti o n 1 0. 4. 1 ) a n d 
fe male (Secti o n 1 0. 4. 2 ) partici pa nts.  
Dise ase C h ar acteristics:  
2.  Pre vi o us d ia g n osis of Ce D, base d o n  d oc u me ntati o n i n t he s o urce data : 
•  P ositi ve celiac ser ol o g y (e g, tiss ue tra ns gl uta mi nase I g A a nti b o d y a n d/ or 
dea mi date d D G P I g G ) 
•  A N D  
•  I ntesti nal hist ol o g y c o nsiste nt wit h ≥ Mars h T y pe II or  wit h e vi de nce of 
vill o us atr o p h y.  
3.  Ha ve H L A -D Q 2. 5 ge n ot y pe ( H L A -D Q A 1 * 0 5 a n d H L A -D Q B 1 * 0 2 ) ( h o m oz y g otes or 
heter oz y g otes) . 
4.  Ne gati ve or wea k p ositi ve f or tra ns gl uta mi nase I g A A N D ne gati ve or wea k p ositi ve 
f or D G P-I g A/I g G d uri n g scree ni n g. 
5.  Scree ni n g i ntesti nal bi o ps y de m o nstrati n g V h: C d rati o of 2. 3 or hi g her .  
Ot her I ncl usi o n  Criteri a : 
6.  Ha ve f oll o we d a gl ute n -free diet f or ≥1 2 m o nt hs i m me diatel y pri or t o st u d y e ntr y  
(self-re p orte d). 
7.  Ca pa ble of u n dersta n di n g  t he I C D, c o m pl yi n g wit h pr ot oc ol re q uire me nts , a n d has 
si g ne d t he I C D. 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 3 9  
5. 2.  E xcl usi o n Criteri a  
Partici pa nts are e xcl u de d fr o m t he st u d y if a n y of t he f oll o wi n g criteria a p pl y: 
Me dic al C o n diti o ns:  
1.  Refract or y Ce D , defi ne d as se vere persiste nt or rec urre nt mala bs or pti ve si g ns or 
s y m pt o ms wit h s u bsta ntial vill o us atr o p h y (e g, d oc u me nte d  Ma rs h sc ore 3c  i n s o urce 
data ) des pite strict a d here nce t o a G F D f or at least 1 2 m o nt hs i n t he a bse nce of ot her 
dis or ders.  
2.  Selecti ve I g A deficie nc y . 
3.  P ositi ve f or H L A -D Q 8 ge n ot y pe  (D Q A 1 * 0 3, D Q B 1 * 0 3 0 2 ) e ve n if D Q 2. 5 is als o 
prese nt .  
4.  K n o w n w heat aller g y . 
5.  Dia g n osis of t y pe -I dia betes. 
6.  Hist or y of der matitis her petif or mis.  
7.  Pre g na nt or breastfee di n g.  
8.  K n o w n hist or y of se vere h y perse nsiti vit y reacti o ns or a na p h yla xis t o gl ute n . 
9.  Acti ve gastr oi ntesti nal disease ot her t ha n Ce D (eg, i nfla m mat or y b o wel disease, a n y 
f or ms of c olitis e xce pt well-c o ntr olle d micr osc o pic c olitis , u nc o ntr olle d I B S, pe ptic 
ulcer  disease, e o si n o p hilic es o p ha gitis, a n d acti ve GI i nfecti o ns ). 
1 0.  Cli nical si g ns a n d s y m pt o ms c o nsiste nt wit h C O VI D -1 9 or c o nfir me d i nfecti o n b y 
a p pr o priate la b orat or y test wit hi n t he 2 wee ks pri or t o scree ni n g or d osi n g.  
•  N ote : partici pa nts w h o e x perie nce d s y m pt o ms c o nsiste nt wit h C O VI D -1 9 or 
c o nfir me d i nfecti o n d uri n g t he scree ni n g peri o d ma y be rescree ne d after 4 
wee ks.  
1 1.  Pri or se vere c o urse of C O VI D -1 9 re q uiri n g e xtrac or p oreal me m bra ne o x y ge nati o n or 
mec ha nical ve ntilati o n  wit hi n t he last 1 2 m o nt hs . 
1 2.  A n y me dical or ps yc hiatric c o n diti o n i ncl u di n g rece nt ( wit hi n t he past year) or acti ve 
s uici dal i deati o n/ be ha vi or or la b orat or y a b n or malit y or si g nifica nt c o m plicati o ns wit h 
pre vi o us E G D or prese nce of si g nifica nt ris k fact ors f or c o m plicati o ns ass ociate d 
wit h E G D, s uc h as A S A P h ysical S tat us III or hi g her (see A p pe n di x 1 1 ), t hat ma y 
i ncrease t he ris k of st u d y partici pati o n or, i n t he i n vesti gat or’s j u d ge me nt, ma ke t he 
partici pa nt i na p pr o priate f or t he st u d y.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 4 0  
Pri or/ C o nc o mit a nt T her a p y:  
1 3.  Pre vi o us treat me nt wit h t olera nce -i n d uci n g t hera pies f or Ce D. 
1 4.  C urre nt use  or i nc o m plete was h o ut  of a n y pr o hi bite d c o nc o mita nt me dicati o n(s) or 
par tici pa nts u n willi n g/ u na ble t o use a per mitte d c o nc o mita nt me dicati o n(s). Refer t o 
Secti o n  6. 9  Pri or a n d C o nc o mita nt T hera p y.  
Pri or/ C o nc urre nt Cli nic al St u d y E x perie nce:  
1 5.  Pre vi o us a d mi nistrati o n wit h a n i n vesti gati o nal pr o d uct ( dr u g or vacci ne)  wit hi n 
3 0  da ys ( or as deter mi ne d b y t he l ocal re q uire me nt) or 5  half -li ves prece di n g t he first 
d ose of st u d y i nter ve nti o n use d i n t his st u d y ( w hic he ver is l o n ger).  
Di a g n ostic Assess me nts:  
1 6.  Re nal im pair me nt as defi ne d b y a n eG F R i n a d ults of <6 0  m L / mi n/ 1. 7 3 m2. Base d 
u p o n partici pa nt a ge at scree ni n g, e G F R is calc ulate d usi n g t he rec o m me n de d 
f or m ulas i n Secti o n 1 0. 7. 2  t o deter mi ne eli gi bilit y a n d t o pr o vi de a baseli ne t o 
q ua ntif y a n y s u bse q ue nt ki d ne y safet y e ve nts.  
1 7.  He patic d ysf u ncti o n defi ne d as:  
•  T otal bilir u bi n ≥1. 5  ×  U L N (e xce pt f or Gil bert’s sy n dr o me ) 
•  A S T ≥1 . 5 ×  U L N  
•  A L T  ≥1 . 5 ×  U L N  
•  Al kali ne p h os p hatase > 1. 5 × U L N  
1 8.  He mat ol o gic a b n or malities defi ne d as:  
•  A N C ≤1 0 0 0  m m 3 
•  Platelets ≤1 0 0 × 1 0 9/L  
•  He m o gl o bi n ≤1 0  g/ d L   
•  W B C o utsi de t he n or mal ra n ge a n d assesse d as cli nicall y si g nifica nt b y t he 
i n vesti gat or. 
1 9.   P ositi ve f or  HI V, he patitis B, a n d/ or he patitis C .  
•  F or He patitis B, all partici pa nts will u n der g o testi n g f or H Bs A g a n d H Bc A b 
d uri n g scree ni n g. Partici pa nts w h o are H Bs A g p osi ti ve are n ot eli gi ble f or t he 
st u d y. Partici pa nts w h o are H Bs A g ne gati ve a n d H Bc A b p ositi ve will be 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 4 1  
refle x teste d f or H Bs A b a n d H B V D N A . If H Bs A b is p ositi ve a n d H B V D N A 
ne gati ve, t he y ma y be e nr olle d i n t he st u d y; if H B s A b is ne gati ve a n d/ or H B V 
D N A is p ositi ve, t he partici pa nt is n ot eli gi ble f or t he st u d y.  
•  F or He patitis C, all partici pa nts will u n der g o H C V A b d uri n g scree ni n g. 
Partici pa n ts wit h p ositi ve H C V A b tests will be refle x teste d f or H C V R N A. 
O nl y partici pa nts wit h ne gati ve H C V A b  or H C V R N A will be all o we d t o 
e nr oll.  
•  F or HI V, k n o w n hist or y of HI V base d o n d oc u me nte d hist or y wit h p ositi ve 
ser ol o gical test, or p ositi ve HI V ser ol o gic test at scree ni n g, teste d at ce ntral  
la b. 
2 0.  Baseli ne sta n dar d 1 2 -lea d E C G t hat de m o nstrates cli nicall y rele va nt a b n or malities 
t hat ma y affect partici pa nt safet y or i nter pretati o n of st u d y res ults (e g, Q TcF  
> 4 5 0  ms, c o m plete L B B B, si g ns of a n ac ute or i n deter mi nate -a ge m y ocar dial 
i nfarcti o n, S T-T i nter val c ha n ges s u g gesti ve of m y ocar dial isc he mia, sec o n d - or 
t hir d-de gree A V bl oc k, or seri o us bra d yarr h yt h mias or tac h yarr h yt h mias).  
•  If t he baseli ne u nc orrecte d Q T i nter val is > 4 5 0 ms, t his i nter val s h o ul d be rate 
c orrecte d usi n g t he Fri dericia met h o d o nl y a n d t he res ulti n g Q Tc F s h o ul d be 
use d f or decisi o n ma ki n g a n d re p orti n g.  
•  If Q TcF  e xcee ds 4 5 0  ms, or Q R S e xcee ds 1 2 0  ms, t he E C G s h o ul d be 
re peate d t wice a n d t he a vera ge of t he 3  Q Tc F  or Q R S val ues use d t o 
deter mi ne t he partici pa nt’s eli gi bilit y.  
•  C o m p uter -i nter prete d E C Gs s h o ul d be o verrea d b y a p h ysicia n e x perie nce d i n 
rea di n g E C Gs bef ore e xcl u di n g a partici pa nt.  
Ot her E xcl usi o n  Criteri a : 
2 1.  I n vesti gat or site staff directl y i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir fa mil y 
me m bers, site staff ot her wise s u per vise d b y t he i n vesti gat or, a n d s p o ns or a n d 
s p o ns or dele gate e m pl o yees directl y i n v ol ve d i n t he c o n d uct of t he st u d y a n d t heir 
fa mil y me m bers. 
5. 3.  Lifest yle C o nsi der ati o ns  
T he f oll o wi n g g ui deli nes are pr o vi de d:  
5. 3. 1.  C o ntr ace pti o n  
T he i n vesti gat or or t heir desi g nee, i n c o ns ultati o n wit h t he partici pa nt, will c o nfir m t hat t he 
partici pa nt is utilizi n g a n a p pr o priate met h o d of c o ntrace pti o n f or t he i n di vi d ual partici pa nt 
a n d t heir part ner(s) fr o m t he per mitte d list of c o ntrace pti o n met h o ds (see A p pe n di x 4 , 
Secti o n 1 0. 4. 4 ) a n d will c o nfir m t hat t he partici pa nt has bee n i nstr ucte d i n its c o nsiste nt a n d 
c orrect use. T he i n vesti gat or or desi g nee will a d vise t he partici pa nt t o see k a d vice a b o ut t he 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 4 2  
d o nati o n a n d cr y o preser vati o n of ger m cells pri or t o t he start of st u d y i nter ve nti o n, if 
a p plica ble. 
At ti me p oi nts i n dicate d i n t he S o A , t he i n vesti gat or or desi g nee will i nf or m t he partici pa nt 
of t he nee d t o use  hi g hl y effecti ve  c o ntrace pti o n c o nsiste ntl y a n d c orrectl y a n d d oc u me nt t he 
c o n versati o n a n d t he partici pa nt’s affir mati o n i n t he partici pa nt’s c hart . P artici pa nts nee d t o 
affir m t heir c o nsiste nt a n d c orrect use of at least 1 of t he selecte d met h o ds of c o ntrace pti o n, 
c o nsi deri n g  t hat t heir ris k f or pre g na nc y ma y ha ve c ha n ge d si nce t he last visit.  
I n a d diti o n, t he i n vesti gat or or desi g nee will i nstr uct t he partici pa nt t o call i m me diatel y if t he 
selecte d c o ntrace pti o n met h o d is disc o nti n ue d a n d d oc u me nt t he re q uire me nt t o use a n 
alter nate pr ot oc ol -s pecifie d met h o d, i ncl u di n g if t he partici pa nt will n o l o n ger use a bsti ne nce 
as t he selecte d c o ntrace pti o n met h o d, or if pre g na nc y is k n o w n or s us pecte d i n t he partici pa nt 
or part ner.  
5. 3. 2.  Me als a n d Diet ar y Restricti o ns  
F oll o wi n g  a G F D  is re q uire d f or st u d y e ntr y (see Secti o n 5. 1 ). 
Partici pa nts are re q uire d t o  c o nti n ue t o f oll o w a G F D  d uri n g t h e st u d y; i nci de ntal gl ute n 
e x p os ure will be c ollecte d dail y as part of a n e Diar y a n d re vie we d at e ver y st u d y visit (see 
Secti o n 8. 3. 1 ). 
Partici pa nt’s use of her bal me dici nes a n d pr o bi otics s h o ul d be re p orte d o n t he C R F a n d 
s h o ul d re mai n sta ble d uri n g t he st u d y. 
5. 3. 3.  C affei ne, Alc o h ol, a n d T o b acc o  
Partici pa nts s h o ul d a v oi d e xcessi ve c o ns u m pti o n of alc o h ol  pri or t o visits wit h safet y la b 
assess me nts as s pecifie d i n t he S o A . 
5. 3. 4.  Acti vit y  
Partici pa nts s h o ul d a v oi d stre n u o us p h ysical acti vities pri or t o visits wit h safet y la b 
assess me nts as s pecifie d i n t he S o A . 
5. 4.  Scree n F ail ures  
Scree n fail ures are defi ne d as partici pa nts w h o c o nse nt t o partici pate i n t he cli nical st u d y b ut 
are n ot s u bse q ue ntl y  ra n d o mize d i n t he st u d y. C R F re p orte d da ta will i ncl u de , b ut is n ot 
li mite d t o, de m o gra p hics, me dical/ Ce D hist or y , a n d pri or Ce D treat me nts . N o n -C R F re p orte d 
data i ncl u de, b ut is n ot li mite d t o H L A a n d Ce D ser ol o g y,  bi o ps y res ults , a n d C D S D v 2. 1  
data c ollecte d u p t o date  of scree n fail ure . N o n -C R F re p orte d data will be tra nsferre d t o t he 
s p o ns or’s desi g nee ( Pfizer), f or all scree n fail ure partici pa nts. Rescree ni n g  
I n di vi d uals w h o d o n ot meet t he criteria f or partici pati o n i n t his st u d y (scree n fail ure) ma y be 
rescree ne d.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 4 3  
Partici pa nts  c a n n ot be rescree ne d  if t he y fail scree ni n g d ue t o:  
•  H L A ge n ot y pi n g assess me nt at scree ni n g . 
•  P ositi ve f or HI V, H B V , or H C V.  
•  Scree ni n g hist ol o g y assess me nt.  
F or rescree ni n g: t he f oll o wi n g assess me nts d o n ot nee d t o be re pe ate d : 
•  H L A  ge n ot y pe assess me nt  
•  C eD ser ol o g y, if < 3 m o nt hs ha ve ela pse d fr o m last  scree ni n g assess me nt  
•  1 2 -lea d E C G , if < 3 m o nt hs  ha ve ela pse d si nce last scree ni n g assess me nt  
•  E G D wit h bi o ps y , if < 3 m o nt hs ha ve ela pse d fr o m last scree ni n g assess me nt 
•  C D S D v 2. 1, if < 3 m o nt hs ha ve ela pse d fr o m last P R O a d mi nistrati o n  
6.  S T U D Y I N T E R V E N TI O N( S) A N D C O N C O MI T A N T T H E R A P Y  
St u d y i nter ve nti o ns are all pres pecifie d i n vesti gati o nal a n d n o ni n vesti gati o nal me dici nal 
pr o d ucts/a u xiliar y me dici nal pr o d ucts , me dical de vices, a n d ot her i nter ve nti o ns (e g, s ur gical 
a n d be ha vi oral) i nte n de d t o be a d mi nistere d t o t he st u d y partici pa nts d uri n g t he st u d y 
c o n d uct.   
F or t he p ur p oses of t his pr ot oc ol, st u d y i nter ve nti o n refers t o K A N -1 0 1 or place b o .  
6. 1.  St u d y I nter ve nti o n(s) A d mi nistere d  
St u d y I nter ve nti o n(s)  
Inter ve nti o n N a me  
K A N -1 0 1  
Place b o  ( Sali ne S ol uti o n) 
A r m N a me  
( gr o u p of partici pa nts  recei vi n g a 
s pecific treat me nt or n o treat me nt) 
K A N -1 0 1  ( Ar m 1) 
Place b o  ( Ar m 2) 
 
T y pe  
D r u g 
 
Dr u g  
D ose F or m ul ati o n  
S ol uti o n f or i nf usi o n  
S ol uti o n f or i nf usi o n  
U nit D ose Stre n gt h(s)  
 
 
  
N A  
D os a ge Le vel(s)  
 
P lace b o 
R o ute of A d mi nistr ati o n  
I V 
I V 
Use  
E x peri me ntal  
P lace b o 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)
C CI
C CI

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 4 4  
St u d y I nter ve nti o n(s)  
I M P or  NI M P / A x M P 
I M P 
P lace b o 
S o urci n g  
Pr o vi de d ce ntrall y b y t he sp o ns or . 
F urt her details are prese nte d i n t he 
I P M. 
Pr o vi de d l ocall y b y t he site.  
F urt her details are prese nte d i n 
t he I P M. 
P ac k a gi n g a n d L a beli n g  
St u d y inter ve nti o n will be 
pr o vi de d i n glass vials , 1 vial per 
cart o n . Eac h vial  a n d cart o n will be 
la bele d as re q uire d per c o u ntr y 
re q uire me nts. 
S t u d y i nter ve nti o n will be p re pare d 
per I P M i nstr ucti o ns  a n d la bele d i n 
a bli n de d ma n ner  per c o u ntr y a n d 
site re q uire me nts. 
Pl ace b o will be pre pare d per 
I P M i nstr ucti o ns a n d la bele d i n 
a bli n de d ma n ner per c o u ntr y 
a n d site re q uire me nts. 
S R S D  
I B 
N A  
 
St u d y Ar m(s)  
Ar m Title  
Ar m 1  
Ar m 2  
Ar m T y pe  
E x peri me ntal  
Place b o  
Ar m Descri pti o n  
Partici pa nts will recei ve 0. 6  m g/ k g 
I V K A N-1 0 1 e ver y 3 da ys starti n g 
o n Da y 1 a n d e n di n g o n Da y 7.  
Partici pa nts will recei ve I V 
place b o e ver y 3 da ys starti n g o n 
Da y 1 a n d e n di n g o n Da y  7.  
Ass oci ate d I nter ve nti o n L a bels  
K A N -1 0 1  
Place b o  
 
6. 1. 1.  A d mi nistr ati o n  
I ncl usi o n a n d e xcl usi o n criteria (Secti o n 5. 1  a n d Secti o n 5. 2 ) s h o ul d be re vie we d pri or t o 
st u d y i nter ve nti o n a d mi nistrati o n (see S o A ). 
K A N -1 0 1 (0. 6  m g/ k g ) is mi xe d wit h sali ne t o a fi nal v ol u me of  2 5 0 m L a n d a d mi nister e d b y 
I V i nf usi o n o ver a p pr o xi matel y 3 0 mi n utes. 
Place b o  will be 2 5 0 m L n or mal sali ne o nl y. Place b o will be a d mi nistere d b y  I V i nf usi o n o ver 
a p pr o xi matel y 3 0 mi n utes.  
A d mi nistrati o n of st u d y i nter ve nti o n(s) at t he site will be perf or me d b y a n a p pr o priatel y 
q ualifie d a n d trai ne d me m ber of t he st u d y staff as all o we d b y l ocal, state, a n d i nstit uti o nal 
g ui da nce.  
F oll o wi n g a d mi nistrati o n of st u d y i nter ve nti o n(s) at t he site, partici pa nts will be o bser ve d f or 
at least 4 h o urs  b y a n a p pr o priatel y q ualifie d a n d trai ne d me m ber of t he st u d y staff. 
A p pr o priate me dicati o n a n d ot her s u p p orti ve meas ures f or ma na ge me nt of a me dical 
e mer ge nc y will be a vaila ble i n acc or da nce wit h l ocal g ui deli nes a n d i nstit uti o nal g ui deli nes.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 4 5  
F or  partici pa nts w h o  ma y e x perie nce na usea a n d /or v o miti n g f oll o wi n g st u d y i nter ve nti o n 
a d mi nistrati o n  o n Da y 1,  a ntie metics (e g , met ocl o pra mi de or o n da nsetr o n) ma y be 
a d mi nistere d 3 0 mi n utes bef ore s u bse q ue nt st u d y i nter ve nti o n a d mi nistrati o n o n Da y 4 
a n d/ or Da y 7 at t he discreti o n of t he i n vesti gat or.  
6. 2.  Pre p ar ati o n , H a n dli n g , St or a ge , a n d Acc o u nt a bilit y  
T his is a d o u ble -bli n d st u d y. F urt her details re gar di n g bli n di n g of st u d y i nter ve nti o n are 
prese nte d i n Secti o n 6. 4 .  
1.  T he i n vesti gat or or desi g nee m ust c o nfir m t hat a p pr o priate c o n diti o ns (e g, 
te m perat ure) ha ve bee n mai ntai ne d d uri n g tra nsit f or all st u d y i nter ve nti o n s recei ve d 
a n d a n y discre pa ncies are re p orte d a n d res ol ve d bef ore use of t he st u d y i nter ve nti o n.  
2.  O nl y partici pa nts e nr olle d i n t he st u d y ma y recei ve st u d y i nter ve nti o n a n d o nl y 
a ut h orize d site staff ma y s u p pl y , pre pare, a n d/or a d mi nister st u d y i nter ve nti o n.  
3.  All st u d y i nter ve nti o n s m ust be st ore d i n a sec ure, e n vir o n me ntall y c o ntr olle d, a n d 
m o nit ore d ( ma n ual or a ut o mate d  rec or di n g) area i n acc or da nce wit h t he la bele d 
st ora ge c o n diti o ns wit h access li mite d t o t he i n vesti gat or a n d a ut h orize d site staff. At 
a mi ni m u m, dail y mi ni m u m a n d ma xi m u m te m perat ures f or all site st ora ge l ocati o ns 
m ust be d oc u me nte d a n d a vaila ble u p o n re q uest. D ata f or n o n w or ki n g da ys m ust 
i n dicate t he mi ni m u m a n d ma xi m u m te m perat ures si nce pre vi o usl y d oc u me nte d  u p o n 
ret ur n t o b usi ness. 
4.  A n y e xc ursi o ns fr o m t he st u d y i nter ve nti o n la bel st ora ge c o n diti o ns s h o ul d be 
re p orte d t o Pfizer  u p o n disc o ver y al o n g wit h acti o ns ta ke n. T he site s h o ul d acti vel y 
p urs ue o pti o ns f or ret ur ni n g t he st u d y i nter ve nti o n t o la bele d st ora ge c o n diti o ns, as 
s o o n as p ossi ble. O nce a n e xc ursi o n is i de ntifie d, t he st u d y i nter ve nti o n m ust be 
q uara nti ne d a n d n ot use d u ntil  Pfizer  pr o vi des per missi o n t o use t he st u d y 
i nter ve nti o n. S pecific details re gar di n g t he e xc ursi o n  defi niti o n a n d i nf or mati o n t o 
re p ort f or eac h e xc ursi o n will be pr o vi de d t o t he site i n t he I PM  or ot her s pecifie d 
l ocati o n. 
5.  A n y st ora ge c o n diti o ns state d i n t he S R S D will be s u perse de d b y t he st ora ge 
c o n diti o ns state d o n t he la bel.  See t he I P M f or st ora ge c o n diti o ns of t he st u d y 
i nter ve nti o n o nce dil ute d.  
6.  St u d y i nter ve nti o ns  s h o ul d be st ore d i n t heir ori gi nal c o ntai ners. 
7.  T he i n vesti gat or, i nstit uti o n, hea d of t he me dical i nstit uti o n ( w here a p plica ble) , or 
a ut h orize d site staff is res p o nsi ble f or st u d y i nter ve nti o n acc o u nta bilit y, 
rec o nciliati o n, a n d rec or d mai nte na nce (ie, recei pt, rec o nciliati o n, a n d fi nal 
dis p ositi o n rec or ds) , s uc h as t he I P A L or s p o ns or or s p o ns or dele gate -a p pr o ve d 
e q ui vale nt . All st u d y i nter ve nti o ns will be acc o u nte d f or usi n g a st u d y i nter ve nti o n 
acc o u nta bilit y f or m/rec or d.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 4 6  
8.  F urt her g ui da nce a n d i nf or mati o n f or t he fi nal dis p ositi o n of u n use d st u d y 
i nter ve nti o ns are pr o vi de d i n t he I PM . All destr ucti o n m ust be a de q uatel y 
d oc u me nte d. If destr ucti o n is a ut h orize d t o ta ke place at t he i n vesti gat or site, t he 
i n vesti gat or m ust e ns ure t hat t he materials are destr o ye d i n c o m plia nce wit h 
a p plica ble e n vir o n me ntal re g ulati o ns, i nstit uti o nal p olic y , a n d a n y s pecial i nstr ucti o ns 
pr o vi de d b y Pfizer . 
U p o n i de ntificati o n of a pr o d uct c o m plai nt, n otif y Pfizer w it hi n 1 b usi ness da y of disc o ver y  
as descri be d i n t he I P M . 
6. 2. 1.  Pre p ar ati o n a n d Dis pe nsi n g  
See t he I PM  f or i nstr ucti o ns o n h o w t o pre pare t he st u d y i nter ve nti o n f or a d mi nistrati o n. 
St u d y i nter ve nti o n  ma y  o nl y  be pre pare d a n d dis pe nse d b y a me m ber of t he site’s desi g nate d 
u n bli n de d pers o n nel a n d m ust be  a n a p pr o priatel y q ualifie d a n d e x perie nce d me m ber of t he 
st u d y staff (e g, p h ysicia n, n urse, p h ysicia n’s assista nt, n urse practiti o ner, p har mac y 
assista nt/tec h nicia n, or p har macist) as all o we d b y l ocal, state, a n d i nstit uti o nal g ui da nce.  A 
sec o n d staff me m ber will verif y calc ulati o ns a n d pa per w or k ass ociate d wit h pre parati o n . N o 
i nf or mati o n re gar di n g t he pre parati o n a n d dis pe nsati o n of st u d y i nter ve nti o n ma y be s hare d 
wit h site’s desi g nate d bli n de d pers o n nel. Bli n di n g of site pers o n nel is f urt her descri be d i n 
Secti o n 6. 4. 2 . T he st u d y i nter ve nti o n will be a d mi nistere d i n a bli n de d fas hi o n t o t he 
partici pa nts.  
6. 3.  Assi g n me nt t o St u d y I nter ve nti o n  
All ocati o n of partici pa nts t o treat me nt gr o u ps will pr ocee d t hr o u g h t he use of a n I R T s yste m. 
T he site pers o n nel ( e g, st u d y c o or di nat or or s pecifie d desi g nee) will be re q uire d t o e nter or 
select i nf or mati o n i ncl u di n g b ut n ot li mite d t o t he user’s I D a n d pass w or d, t he pr ot oc ol 
n u m ber, a n d t he partici pa nt  n u m ber. T he site pers o n nel will t he n be pr o vi de d wit h  a 
ra n d o mizati o n n u m ber c orres p o n di n g t o t he assi g ne d treat me nt gr o u p , a n d D U or c o ntai ner 
n u m ber (s) w he n st u d y i nter ve nti o n is bei n g s u p plie d via t he I R T s yste m. T he I R T s yste m 
will pr o vi de a c o nfir mati o n re p ort c o ntai ni n g t he partici pa nt  n u m ber, ra n d o mizati o n n u m ber, 
a n d D U or c o ntai ner n u m ber assi g ne d. T he c o nfir mati o n re p ort m ust be st ore d i n t he site’s 
files. Bli n di n g of site pers o n nel is descri be d i n Secti o n 6. 4. 2 . 
St u d y i nter ve nti o n  will be dis pe nse d at t he st u d y visits s u m marize d i n t he S o A .  
T he st u d y -s pecific I R T refere nce ma n ual a n d I PM  will pr o vi de t he c o ntact i nf or mati o n a n d 
f urt her details o n t he use of t he I R T s yste m. 
6. 4.  Bli n di n g  
T his is a d o u ble -bli n d st u d y.  
6. 4. 1.  Bli n di n g of P artici p a nts  
P artici pa nts a n d t heir care gi vers will be bli n de d  t o t heir assi g ne d st u d y i nter ve nti o n. 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 4 7  
6. 4. 2.  Bli n di n g of Site Pers o n nel  
In vesti gat ors a n d ot her site staff will be bli n de d  t o partici pa nts’ assi g ne d st u d y i nter ve nti o n. 
Partici pa nts will be assi g ne d t o recei ve st u d y i nter ve nti o n acc or di n g t o t he assi g ne d treat me nt 
gr o u p fr o m t he ra n d o mizati o n sc he me. I n vesti gat ors will re mai n bli n de d t o eac h partici pa nt’s 
assi g ne d st u d y i nter ve nt i o n t hr o u g h o ut t he c o urse of t he st u d y. 
U n bli n de d pers o n nel  i ncl u de site staff i n v ol ve d i n st u d y i nter ve nti o n pre parati o n a n d 
all ocati o n (e g, data s yste ms s u p p ort a n d p har macists).   
I n or der t o mai ntai n t his bli n d, a n ot her wise u ni n v ol ve d t hir d part y will be res p o nsi ble f or t he 
pre parati o n a n d dis pe nsi n g of all st u d y i nter ve nti o n a n d will e n dea v or t o e ns ure t hat t here are 
n o differe nces i n t he ti me ta ke n t o dis pe nse or vis ual prese nta ti o n, f oll o wi n g ra n d o mizati o n 
or dis pe nsi n g.  
I n t he e ve nt of a Q ualit y Ass ura nce a u dit, t he a u dit or(s) will be all o we d access t o u n bli n de d 
st u d y i nter ve nti o n rec or ds at t he site(s) t o verif y t hat ra n d o mizati o n/ dis pe nsi n g has bee n d o ne 
acc uratel y. 
6. 4. 3.  Bli n di n g of t he S p o ns or  
S p o ns or  a n d s p o ns or -dele gate  staff will be bli n de d t o partici pa nts’ assi g ne d st u d y 
i nter ve nti o n, e xce pt f or s p o ns or a n d s p o ns or -dele gate -staff i n v ol ve d i n t he assi g n me nt or 
distri b uti o n of st u d y i nter ve nti o n.  S p o ns or  a n d s p o ns or -dele gate  staff w h o are n ot directl y 
i n v ol ve d wit h t he c o n d uct of t his st u d y will pre pare a nal yses a n d d oc u me ntati o n c o ntai ni n g 
u n bli n de d data w hile t he st u d y is o n g oi n g t o s u p p ort i nteracti o ns wit h t he D S M B.  
6. 4. 4.  Bre a ki n g t he Bli n d  
T he I R T will be pr o gra m me d wit h bli n d -brea ki n g i nstr ucti o ns. I n case of a n e mer ge nc y, t he 
i n vesti gat or has t he s ole res p o nsi bilit y f or deter mi ni n g if u n bli n di n g of a partici pa nt’s 
treat me nt assi g n me nt is warra nte d. Partici pa nt safet y m ust al wa ys be t he first c o nsi derati o n 
i n ma ki n g s uc h a deter mi nati o n. If t he i n vesti gat or deci des t hat u n bli n di n g is warra nte d, t he 
i n vesti gat or s h o ul d ma ke e ver y eff ort t o c o ntact t he st u d y me dical m o nit or  pri or t o 
u n bli n di n g a partici pa nt’s treat me nt assi g n me nt u nless t his c o ul d dela y f urt her ma na ge me nt 
of t he partici pa nt.  If a partici pa nt’s treat me nt assi g n me nt is u n bli n de d, Pfizer  m ust be 
n otifie d wit hi n 2 4 h o urs after brea ki n g t he bli n d. T he date a n d reas o n t hat t he bli n d was 
br o ke n m ust be rec or de d i n t he s o urce d oc u me ntati o n a n d C R F.  
T he st u d y -s pecific I R T refere nce ma n ual a n d I PM  will pr o vi de t he c o ntact i nf or mati o n a n d 
f urt her details o n t he use of t he I R T s yste m. 
6. 5.  St u d y I nter ve nti o n C o m pli a nce  
T he p har mac y  will c o m plete t he D ose Calc ulati o n W or ks heet  w hic h will be pr o vi de d as part 
of t he I P M . T he use of t he D ose Calc ulati o n W or ks heet  is preferre d, b ut it d oes n ot precl u de 
t he use of a n e xisti n g a p pr o priate cli nical site d oc u me ntati o n s yste m. T he e xisti n g cli nical 
site's d oc u me ntati o n s yste m s h o ul d ca pt ure all perti ne nt/re q uire d i nf or mati o n o n t he 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 4 8  
pre parati o n a n d a d mi nistrati o n of t he d ose. T his ma y be use d i n place of t he D ose 
Calc ulati o n W or ks heet after a p pr o val fr o m t he s p o ns or a n d/ or desi g nee.  
C o m plia nce wit h t he st u d y i nter ve nti o n is defi ne d as recei vi n g 1 0 0 % of t he d oses as 
s pecifie d per pr ot oc ol.  
6. 6.  D ose M o dific ati o n   
N o d ose m o dificati o n is all o we d.   
6. 7.  C o nti n ue d Access t o St u d y I nter ve nti o n A fter t he E n d of t he St u d y 
N o st u d y i nter ve nti o n will be pr o vi de d t o partici pa nts at t he e n d of t heir st u d y partici pati o n. 
It is e x pecte d t hat partici pa nts will be treate d as re q uire d wit h sta n dar d -of -care treat me nts, as 
a d vise d b y t heir us ual care p h ysicia n.  
6. 8.  Tre at me nt of O ver d ose  
F or t his st u d y, a n y d ose of st u d y i nter ve nti o n greater t ha n  t he ma xi m u m d ose of st u d y 
i nter ve nti o n acc or di n g t o t he pr ot oc ol  wit hi n a 2 4 -h o ur  ti me peri o d will be c o nsi dere d a n 
o ver d ose.  
T here is n o  s pecific treat me nt f or a n o ver d ose. 
I n t he e ve nt of a n o ver d ose, t he i n vesti gat or/treati n g p h ysicia n s h o ul d: 
1.  C o ntact t he  st u d y me dical m o nit or wit hi n 2 4 h o urs.  
2.  Cl osel y m o nit or t he partici pa nt f or a n y A Es/ S A Es a n d la b orat or y a b n or malities as 
me dicall y a p pr o priate a n d f oll o w u p u ntil res ol uti o n, sta bilizati o n, t he e ve nt is 
ot her wise e x plai ne d, or t he partici pa nt is l ost t o f oll o w -u p (as defi ne d i n Secti o n  7. 3 ).  
3.  D oc u me nt t he q ua ntit y of t he e xcess d ose as well as t he d urati o n of t he o ver d ose i n 
t he C R F. 
4.  O ver d ose is re p orta ble t o t he Pfizer  o nl y w he n ass oci ate d wit h a n S A E.  
5.  O btai n a bl o o d sa m ple f or P K a nal ysis as s o o n as o ver d ose is i de ntifie d b ut n o later 
t ha n 2 4 h o urs fr o m t he last o ver -d ose d  st u d y i nter ve nti o n if re q ueste d b y t he st u d y 
me dical m o nit or ( deter mi ne d o n a case -b y -case basis).  
Decisi o ns re gar di n g d ose i nterr u pti o ns or m o dificati o ns will be ma de b y t he i n vesti gat or i n 
c o ns ultati o n wit h t he st u d y me dical m o nit or as nee de d base d o n t he cli nical e val uati o n of t he 
partici pa nt.   
6. 9.  Pri or a n d C o nc o mit a nt T her a p y  
All partici pa nts are re q uire d t o mai ntai n sta ble d osi n g of per mitte d prescri be d a n d O T C 
me dicati o ns f or t he d urati o n of t he st u d y.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 4 9  
6. 9. 1.  Pr o hi bite d D uri n g t he St u d y  
T he f oll o wi n g t hera pies are pr o hi bite d d uri n g t he st u d y :  
•  A n y a d diti o nal t hera pies t o treat Ce D . 
•  O t her i n vesti gati o nal a ge nts, i ncl u di n g bi ol o gic or n o n-bi ol o gic i m m u n os u p pressi ve 
or i m m u n o m o d ulat or y t hera pies . 
•  Was h o ut peri o d f or c hr o nic, s yste mic n o n -bi ol o gic i m m u n os u p pressi ve or 
i m m u n o m o d ulat or y a ge nts (e g, met h otre xate, s ulfasalazi ne, or c ortic oster oi ds 
s uc h as pre d nis o ne, etc.) is 3 m o nt hs pri or t o scree ni n g.   
•  Was h o ut peri o d f or bi ol o gic i m m u n os u p pressi ve or i m m u n o m o d ulat or y a ge nts  
(e g, a dali m u ma b, eta nerce pt, cert oliz u ma b) is 1 2 m o nt hs pri or t o scree ni n g; 
e xce pt  a nti-se vere ac ute res pirat or y s y n dr o me c or o na vir us 2 m o n ocl o nal 
a nti b o dies .  
•  N o n -i n vesti gati o nal s yste mic i m m u n os u p pressi ve a n d i m m u n o m o d ulat or y t hera pies 
(e g, I V or oral c ortic oster oi ds).  C ortic oster oi ds  a d mi nistere d t o picall y or b y 
i n halati o n or ot her wa ys ma y be all o we d b ut s h o ul d be disc usse d wit h me dical 
m o nit or pri or t o e nr oll me nt i n t he st u d y or i nitiati o n of ne w treat me nt.  
•  All vacci nes bet wee n 4 wee ks pri or t o d osi n g t hr o u g h 4 wee ks fr o m t he last d ose of 
st u d y i nter ve nti o n; vacci nes are per mitte d at all ot her ti mes d uri n g t he st u d y .  
6. 9. 2.  Per mitte d D uri n g t he St u d y  
H or m o nal c o ntrace pti ves t hat meet t he re q uire me nts of t his st u d y are all o we d t o be use d i n 
partici pa nts w h o are W O C B P (see A p pe n di x 4 ). 
H R T use b y p ost me n o pa usal w o me n is per mitte d if t he y meet re q uire me nts i n A p pe n di x 4 . 
A n y ot her me dicati o n t hat is c o nsi dere d necessar y f or t he partici pa nt’s  welfare t hat is n ot 
e x pecte d t o i nterfere wit h t he e val uati o n of K A N -1 0 1 ma y be gi ve n at t he discreti o n of t he 
in vesti gat or  a n d d oc u me nte d o n t he C R F.  
I n cases i n v ol vi n g c o nc o mita nt t hera pies w h ose pre dicte d i nterfere nce wit h K A N-1 0 1 is 
u n k n o w n t o t he in vesti gat or, Pfizer  s h o ul d be c o ntacte d f or disc ussi o n.  
A n y me dicati o n (i ncl u di n g o ver -t he-c o u nter or prescri pti o n me dicati o ns, vita mi ns, a n d/ or 
her bal s u p ple me nts) t hat t he partici pa nt  recei ves after e nr oll me nt t hr o u g h t he last st u d y visit 
m ust be rec or de d o n t he C R F.  Partici pa nts s h o ul d re p ort a n y c ha n ges t o per mitte d 
me dicati o ns d uri n g t he st u d y t o t he i n vesti gat or as s o o n as t he y occ ur. Me dicati o n c ha n ges 
m ust be d oc u me nte d i n t he partici pa nt’s rec or d a n d C R F.  
Partici pa nts bei n g treate d f or I B S s y m pt o m ol o g y  w ill be all o we d t o c o nti n ue c urre nt 
treat me nt (e g, dic ycl o mi ne) u nless t he dr u g is s pecificall y pr o hi bite d; partici pa nts s h o ul d be 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 5 0  
o n a sta ble d ose f or at least 4 wee ks pri or t o e ntr y a n d re mai n o n a sta ble d ose t hr o u g h o ut t he 
st u d y.  
A nti diarr heal (e g , l o pera mi de), a ntie metics (e g , met ocl o pra mi de  or o n da nsetr o n ), or 
aceta mi n o p he n  ma y be use d f or s y m pt o matic treat me nt if warra nte d u nless t he dr u g is 
s pecificall y pr o hi bite d. T hese s y m pt o matic treat me nts are o pti o nall y  all o we d as pre -
treat me nt t o st u d y i nter ve nti o n a d mi nistrati o n at Da y 4 a n d Da y 7 at i n vesti gat or discreti o n. 
If gi ve n at a st u d y visit , use m ust be rec or de d o n t he C R F.  
6. 9. 3.  Resc ue Me dici ne  
T here is n o resc ue t hera p y t o re verse A Es o bser ve d wit h K A N-1 0 1; sta n dar d me dical 
s u p p orti ve care, s uc h as a ntie metics (e g , met ocl o pra mi de or o n da nsetr o n) , ma y  be pr o vi de d 
t o ma na ge A Es. 
7.  DI S C O N TI N U A TI O N O F S T U D Y I N T E R V E N TI O N A N D P A R TI CI P A N T 
DI S C O N TI N U A TI O N/ WI T H D R A W A L  
7. 1.  Disc o nti n u ati o n of St u d y I nter ve nti o n  
It ma y be necessar y f or a partici pa nt  t o per ma ne ntl y disc o nti n ue st u d y i nter ve nti o n. Reas o ns 
f or per ma ne nt  disc o nti n uati o n of st u d y i nter ve nti o n i ncl u de t he f oll o wi n g : 
•  A n A E t hat re q uires per ma ne nt disc o nti n uati o n of st u d y treat me nt * ; 
•  N o nc o m plia nce wit h t he pr ot oc ol;  
•  I n vesti gat or decisi o n; 
•  Partici pa nt bec o mes pre g na nt;  
•  Partici pa nt deat h;  
•  Partici pa nt l ost t o f oll o w-u p;  
•  Ter mi nati o n of t he st u d y b y t he sp o ns or;  
•  V ol u ntar y wit h dra wal of c o nse nt b y t he partici pa nt .  
* N ote: A Es lea di n g t o t he disc o nti n uati o n of st u d y i nter ve nti o n will be f oll o we d u ntil 
res ol uti o n, sta bilizati o n, t he e ve nt is ot her wise e x plai ne d, or t he partici pa nt is l ost t o f oll o w -
u p.  
N ote t hat disc o nti n uati o n of st u d y i nter ve nti o n d oes n ot re prese nt wit h dra wal fr o m t he st u d y.  
If st u d y i nter ve nti o n is per ma ne ntl y  disc o nti n ue d, t he partici pa nt s h o ul d re mai n i n t he st u d y 
t o be e val uate d f or safet y. See t he S o A  f or data t o be c ollecte d at t he ti me of disc o nti n uati o n 
of st u d y i nter ve nti o n a n d f oll o w -u p f or a n y f urt her e val uati o ns t hat nee d t o be c o m plete d.  
I n t he e ve nt of disc o nti n uati o n of st u d y i nter ve nti o n, it m ust be d oc u me nte d o n t he 
a p pr o priate C R F/i n t he me dical rec or ds w het her t he partici pa nt is disc o nti n ui n g f urt her 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 5 1  
recei pt of st u d y i nter ve nti o n or als o fr o m st u d y pr oce d ures, f urt her st u d y f oll o w-u p, a n d/ or 
f ut ure c ollecti o n of a d diti o nal i nf or mati o n.  
Partici pa nts w h o wit h dra w fr o m treat me nt a n d d o n ot recei ve 3 f ull d oses s h o ul d n ot u n der g o 
G C , ha ve plas ma sa m ples ta ke n f or I L -2 o n Da y 1 5 , Da y 2 9, a n d Da y 4 2, or recei ve a sec o n d 
E G D wit h bi o ps y.   
7. 1. 1.  Li ver  I nj ur y 
A partici pa nt w h o meets t he criteria as descri be d i n A p pe n di x 6  will be wit h dra w n fr o m 
st u d y i nter ve nti o n. 
7. 1. 2.  Pre g n a nc y  
Pre g na nc y tests are c o n d ucte d as s pecifie d per t he S o A  a n d a d mi nistrati o n of st u d y 
i nter ve nti o n or 2 -wee k G C will o nl y be i nitiate d  i n t he prese nce of a ne gati ve pre g na nc y test. 
If a partici pa nt is c o nfir me d t o be pre g na nt (see Secti o n 8. 3. 6 ) d uri n g a n y visit, c o n d ucti n g of 
G Cs a n d f urt her d osi n g wit h st u d y i nter ve nti o n will be disc o nti n ue d i m me diatel y a n d 
per ma ne ntl y.  
Secti o n 8. 4. 5. 1  descri bes t he f oll o w -u p acti vities if a partici pa nt meets E D P criteria.  
7. 1. 3.  C O VI D -1 9  
If a partici pa nt has C O VI D-1 9 d uri n g t he st u d y, t his s h o ul d be re p orte d as a n A E or S A E (as 
a p pr o priate ) a n d a p pr o priate me dical i nter ve nti o n pr o vi de d.  
It is rec o m me n de d t hat t he i n vesti gat or disc uss te m p orar y or per ma ne nt disc o nti n uati o n of 
st u d y i nter ve nti o n wit h t he st u d y me dical m o nit or.  
7. 1. 4.  Te m p or ar y Disc o nti n u ati o n   
I n cases w here a te m p orar y disc o nti n uati o n or d osi n g i nterr u pti o n  is re q uire d, t he t otal 
i nf usi o n s h o ul d be c o m plete d wit hi n 6  h o urs of t ha wi n g t he dr u g pr o d uct. A n y te m p orar y 
disc o nti n uati o ns or i nterr u pti o ns of st u d y i nter ve nti o n s h o ul d be d oc u me nte d i n t he C R F.  
See A p pe n di x 9  f or detaile d g ui da nce re gar di n g i nf usi o n a d mi nistrati o n i nterr u pti o ns d ue t o 
I R R. 
7. 2.  P artici p a nt Disc o nti n u ati o n/ Wit h dr a w al  F r o m t he St u d y  
A partici pa nt ma y wit h dra w fr o m t he st u d y at a n y ti me at their  o w n re q uest . Reas o ns f or 
disc o nti n uati o n fr o m t he st u d y i ncl u de t he f oll o wi n g :  
•  I n vesti gat or’s decisi o n; 
•  Partici pa nt deat h;  
•  Partici pa nt l ost t o f oll o w -u p;  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 5 2  
•  Ter mi nati o n of t he st u d y b y S p o ns or;  
•  Vol u ntar y wit h dra wal of c o nse nt of partici pa nt.  
At t he ti me of disc o nti n ui n g fr o m t he st u d y, if p ossi ble, a n earl y disc o nti n uati o n visit s h o ul d 
be c o n d ucte d . See t he S o A  f or assess me nts  t o be c ollecte d at t he ti me of st u d y 
disc o nti n uati o n a n d f oll o w -u p a n d f or a n y f urt her e val uati o ns t hat nee d t o be c o m plete d.   
I n or der t o mai ntai n t his bli n d, a n ot her wise u ni n v ol ve d t hir d part y will be res p o nsi ble f or 
a d mi nistrati o n of t he st u d y i nter ve nti o n. T his i ncl u des e ns uri n g t hat t here are n o differe nces 
i n ti me or eff ort ta ke n t o a d mi nister t he st u d y i nter ve nti o n a n d n o bli n de d site staff are a ble 
t o vie w t he a d mi nistrati o n. 
T he partici pa nt will be per ma ne ntl y disc o nti n ue d fr o m t he st u d y i nter ve nti o n a n d t he st u d y at 
t hat ti me. 
If a partici pa nt wit h dra ws fr o m t he st u d y, t he y ma y re q uest destr ucti o n of a n y re mai ni n g 
sa m ples ta ke n a n d n ot teste d, a n d the i n vesti gat or m ust d oc u me nt a n y s uc h re q uests i n t he 
site st u d y rec or ds a n d n otif y Pfizer  acc or di n gl y. 
If t he partici pa nt wit h dra ws fr o m t he st u d y a n d als o wit h dra ws c o nse nt ( see Secti o n 7. 2. 1 ) 
f or discl os ure of f ut ure i nf or mati o n, n o f urt her e val uati o ns will be perf or me d a n d n o 
a d diti o nal data will be c ollecte d. T he s p o ns or or desi g nee ma y retai n a n d c o nti n ue t o use a n y 
data c ollecte d bef ore s uc h wit h dra wal of c o nse nt.  
7. 2. 1.  Wit h dr a w al of C o nse nt  
Partici pa nt s w h o re q uest t o disc o nti n ue recei pt of st u d y i nter ve nti o n will re mai n i n t he st u d y 
a n d m ust c o nti n ue t o be f oll o we d f or pr ot oc ol -s pecifie d f oll o w-u p pr oce d ures. T he o nl y 
e xce pti o n t o t his is w he n a partici pa nt  s pecificall y wit h dra ws c o nse nt f or a n y f urt her c o ntact 
wit h t he m or pers o ns pre vi o usl y a ut h orize d b y t he partici pa nt  t o pr o vi de t his i nf or mati o n. 
Partici pa nt s s h o ul d n otif y t he i n vesti gat or i n writi n g of t he decisi o n t o wit h dra w c o nse nt 
fr o m f ut ure f oll o w-u p, w he ne ver p ossi ble. T he wit h dr a wal of c o nse nt s h o ul d be e x plai ne d i n 
detail i n t he me dical rec or ds b y t he i n vesti gat or, as t o w het her t he wit h dra wal is o nl y fr o m 
f urt her recei pt of st u d y i nter ve nti o n or als o fr o m st u d y pr oce d ures a n d/ or p osttreat me nt st u d y 
f oll o w-u p, a n d e ntere d o n t he a p pr o priate C R F pa ge. I n t he e ve nt t hat vital stat us ( w het her 
t he partici pa nt  is ali ve or dea d) is bei n g meas ure d, p u blicl y a vaila ble i nf or mati o n s h o ul d be 
use d t o deter mi ne vital stat us o nl y as a p pr o priatel y directe d i n acc or da nce wit h l ocal la w.  
7. 3.  L ost t o F ol l o w-U p  
A partici pa nt will be c o nsi dere d l ost t o f oll o w -u p if t he partici pa nt re peate dl y fails t o ret ur n 
f or sc he d ule d visits a n d is u na ble t o be c o ntacte d b y t he st u d y site. 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 5 3  
T he f oll o wi n g acti o ns m ust be ta ke n if a partici pa nt fails t o  ret ur n t o t he cli nic f or a re q uire d 
st u d y visit: 
•  T he site m ust atte m pt t o c o ntact t he partici pa nt a n d resc he d ule t he misse d visit as 
s o o n as p ossi ble. C o u nsel t he partici pa nt o n t he i m p orta nce of mai ntai ni n g t he 
assi g ne d visit sc he d ule , a n d ascertai n w het her t he partici pa nt wis hes t o a n d/ or s h o ul d 
c o nti n ue i n t he st u d y ; 
•  Bef ore a partici pa nt is dee me d l ost t o f oll o w -u p, t he i n vesti gat or or desi g nee m ust 
ma ke e ver y eff ort t o re gai n c o ntact wit h t he partici pa nt ( w here p ossi ble, 3 tele p h o ne 
calls a n d, if necessar y, a certifie d letter t o t he partici pa nt’s last k n o w n maili n g 
a d dress or l ocal e q ui vale nt met h o ds).  T hese c o ntact atte m pts s h o ul d be d oc u me nte d 
i n t he partici pa nt’s me dical rec or d; 
•  S h o ul d t he partici pa nt c o nti n ue t o be u nreac ha ble, t he partici pa nt will be c o nsi dere d 
t o ha ve wit h dra w n fr o m t he st u d y.  
8.  S T U D Y A S S E S S M E N T S A N D P R O C E D U R E S  
8. 1.  A d mi nistr ati ve  Pr oce d ures  
T he i n vesti gat or ( or a n a p pr o priate dele gate at t he i n vesti gat or site) m ust  o btai n a si g ne d a n d 
date d I C D bef ore perf or mi n g a n y st u d y -s pecific pr oce d ures.  
St u d y pr oce d ures a n d t heir ti mi n g are s u m marize d i n t he S o A . Pr ot oc ol wai vers or 
e xe m pti o ns are n ot all o we d.  
A d here nce t o t he st u d y desi g n re q uire me nts, i ncl u di n g t h ose s pecifie d i n t he S o A , is esse ntial 
a n d re q uire d f or st u d y c o n d uct.  
All scree ni n g e val uati o ns m ust be c o m plete d a n d re vie we d t o c o nfir m t hat p ote ntial 
partici pa nts meet all eli gi bilit y criteria. T he i n vesti gat or will mai ntai n a scree ni n g l o g t o 
rec or d details of all partici pa nts scree ne d a n d t o c o nfir m eli gi bilit y or rec ord reas o ns f or 
scree ni n g fail ure, as a p plica ble. 
E ver y eff ort s h o ul d be ma de t o e ns ure t hat pr ot oc ol -re q uire d tests a n d pr oce d ures are 
c o m plete d as descri be d. H o we ver, it is a ntici pate d t hat fr o m ti me t o ti me t here ma y be 
circ u msta nces o utsi de t he c o ntr ol of t he i n vesti gat or t hat ma ke it u nfeasi ble t o perf or m t he 
test. I n t hese cases, t he i n vesti gat or m ust ta ke all ste ps necessar y t o e ns ure t he safet y a n d 
well -bei n g of t he partici pa nt . W he n a pr ot oc ol-re q uire d test ca n n ot be perf or me d, t he 
i n vesti gat or will d oc u me nt t he reas o n f or t he misse d test a n d a n y c orrecti ve a n d pre ve nti ve 
acti o ns t hat t he y ha ve ta ke n t o e ns ure t hat re q uire d pr ocesses are a d here d t o as s o o n as 
p ossi ble. T he st u d y tea m m ust be i nf or me d of t hese i nci de nts i n a ti mel y ma n ner.  
F or sa m ples bei n g c ollecte d a n d s hi p pe d, detaile d c ollecti o n, pr ocessi n g, st ora ge, a n d 
s hi p me nt i nstr ucti o ns a n d c o ntact i nf or mati o n will be pr o vi de d t o t he i n vesti gat or site pri or 
t o i nitiati o n of t he st u d y. 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 5 4  
T he act ual c ollecti o n ti mes of bl o o d sa m pli n g ma y c ha n ge. A d diti o nal bl o o d sa m ples ma y be 
ta ke n f or safet y assess me nts at ti mes s pecifie d b y t he s p o ns or or s p o ns or ’s desi g nee , 
pr o vi de d t he t otal v ol u me ta ke n d uri n g t he st u d y d oes n ot e xcee d 5 5 0  m L wit hi n 6 0 da ys .  
8. 1. 1.  Tele he alt h Visits  
Tele healt h visits ma y be use d t o assess partici pa nt safet y a n d c ollect data p oi nts. Tele healt h 
i ncl u des t he e xc ha n ge of healt hcare i nf or mati o n a n d ser vices via telec o m m u nicati o n 
tec h n ol o gies (e g, a u di o, vi de o, vi de oc o nfere nci n g s oft ware) re m otel y, all o wi n g t he 
partici pa nt a n d t he i n vesti gat or t o c o m m u nicate o n as pects of cli nical care, i ncl u di n g me dical 
a d vice, re mi n ders, e d ucati o n, a n d safet y m o nit ori n g. Assess me nts t hat ma y be perf or me d 
d uri n g a tele healt h visit are descri be d i n t he S o A . 
St u d y partici pa nts m ust be re mi n de d t o  pr o m ptl y  n otif y  site staff a b o ut a n y c ha n ge i n t heir 
healt h stat us.   
8. 2.  Effic ac y Assess me nts  
Efficac y assess me nts are perf or me d at ti mes s pecifie d i n t he S o A . 
8. 2. 1.  Gl ute n C h alle n ge  
All eli gi ble, e nr olle d partici pa nts t hat recei ve d all t hree d oses of st u d y i nter ve nti o n will 
u n der g o a 2-wee k G C at starti n g Da y 1 5.  
•  Partici pa nts are re q uire d t o fast f or at least 6 h o urs  ( or o ver ni g ht), e xce pt f or water 
a n d a n y me dicati o ns t he y mi g ht ha ve pre vi o usl y bee n prescri be d , pri or t o G C. T his 
pertai ns t o b ot h t he st u d y cli nic visit d uri n g w hic h t he G C is perf or me d (see S o A ) a n d 
t he at-h o me G C.  
•  At t he Da y 1 5 st u d y visit, a  q ualifie d staff me m ber will pre pare t he G C . 
•  Partici pa nts will  c o ns u me  9 g of gl ute n pr otei n  P O i n t he cli nic a n d t he partici pa nt will 
be o bser ve d f or at least 4 h o urs t o m o nit or f or h y perac ute reacti o ns re q uiri n g me dical 
treat me nt a n d c ollecti o n of bi o mar ker sa m ples.  
•  Materials will be se nt h o me wit h t he partic i pa nt t o c o m plete t he G C dail y f or t he ne xt 
1 3 da ys . 
C o m pleti o n  of  t he G C is defi ne d as c o ns u m pti o n of t he e ntiret y of t he 9 g G C wit hi n 
a p pr o xi matel y 1 5 mi n utes.   
•  At t he Da y 1 5 visit, p artici pa nts will c o ns u me t he G C o n site u n der t he o bser vati o n of 
site staff. Partici pa nts will c o m plete t he re mai ni n g da ys of G C at h o me  a n d d oc u me nt 
t he c o m pleti o n of t he G C via t he e Diar y.  
C o m plia nce wit h t he G C is defi ne d as c o m pleti o n of all 1 4 da ys of t he G C. O nl y partici pa nts 
f ull y c o m plia nt wit h t he G C ma y be a nal yze d as part of t he P P S (see Secti o n 9. 3 ).  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 5 5  
O nl y partici pa nts w h o ha ve c o m plete d at least 7 da ys of G C s h o ul d u n der g o t he sec o n d E G D 
wit h bi o ps y . F or  partici pa nts w h o:   
•  C o nti n ue i n t he st u d y , t he E G D wit h bi o ps y will ta ke place at t he Da y 2 9  visit 
(see S o A ).  
•  D isc o nti n ue earl y, t he E G D  wit h bi o ps y will ta ke place at t he E T visit (see S o A ). 
A n y s y m pt o ms ass ociate d wit h t he G C s h o ul d be rec or de d as A Es ( see Secti o n  8. 4 ). A n y 
A Es ass ociate d wit h t he G C st u d y assess me nt are se parate t o A Es relate d t o st u d y 
i nter ve nti o n ( K A N-1 0 1/ p lace b o).  
8. 2. 2.  Pl as m a I L -2 Bi o m ar ker Assess me nt   
Plas ma sa m ples will be c ollecte d t o assess t he ma g nit u de of bi o mar ker res p o nse of I L -2 pre - 
a n d p ost -G C  i n peri p heral bl o o d at ti mes s pecifie d i n t he S o A . 
F urt her details are prese nte d i n Secti o n 8. 7 . 
8. 2. 3.  P atie nt Re p orte d O utc o mes  
P R Os will be c ollecte d via e Diar y.  
8. 2. 3. 1.  C D S D v 2. 1  
T he  C D S D  v 2. 1 , a n o vel patie nt-re p orte d o utc o me meas ure de vel o pe d f or use wit h 
partici pa nts  wit h Ce D, c o nsists of fi ve s y mpt o ms i ncl u di n g diarr hea, a b d o mi nal pai n, 
bl oati n g, na usea, a n d tired ness . T he C D S D v 2. 1  assesses  se verit y, i n fi ve scales fr o m “ n o ne” 
t o “ ver y se vere”, a n d fre q ue nc y . T he C D S D v 2. 1  will be assesse d dail y  as part of t he e Diar y  
be gi n ni n g d uri n g t he scree ni n g peri o d  after si g ni n g t he I C D.  
T he C D S D v 2. 1 s h o ul d be c o m plete d f or at least 7 c o nsec uti ve da ys d uri n g scree ni n g  at a n y 
ti me pri or t o t he baseli ne visit  ( Da y 1). After scree ni n g a n d t hr o u g h t he e n d of t he st u d y, 
c o m plia nce wit h t he C D S D v 2. 1 is defi ne d as 8 0 % c o m pleti o n.  
8. 2. 3. 2.  P GI C  
T he P GI C is a patie nt -c o m plete d q uesti o n t o assess t he o verall i m pressi o n of disease 
i m pr o ve me nt e x perie nce d b y t he partici pa nt . T he P GI C sc ore ra n ges fr o m “m uc h better ” t o 
“m uc h w orse ”. T he P GI C will be assesse d at visits s pecifie d i n S o A .  
8. 2. 3. 3.  P GI S  
T he P GI S is a patie nt -c o m plete d q uesti o n t o assess t he o verall i m pressi o n of disease se verit y 
e x perie nce d b y t he partici pa nt . T he P GI S sc ore ra n ges fr o m “N o ne ” t o “Ver y Se vere ”. T he 
P GI S will be assesse d at visits s pecifie d i n S o A .  
8. 2. 4.  E s o p h a g og astr o d u o de n osc o p y W it h B i o ps y 
E G D  wit h bi o psies will be c ollecte d fr o m partici pa nts at ti mes s pecifie d i n t he S o A .  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 5 6  
E G D  wit h bi o ps y  will be perf or me d b y a q ualifie d gastr oe nter ol o gist at eac h site. All st u d y 
gastr oe nter ol o gists will be trai ne d o n t he st u d y -s pecific pr oce d ures f or o btai ni n g t he bi o ps y, 
i ncl u di n g t he l ocati o n a n d n u m ber of bi o psies t o be o btai ne d as well as t he  pr oce d ures f or 
st ori n g a n d s hi p pi n g of sa m ples.  
A p pr o xi matel y  6  d u o de nal  bi o psies will be o btai ne d  per c ollecti o n . 
E n d osc o p y data o btai ne d d uri n g scree ni n g  ma y be use d as t he baseli ne h ist ol o g y i n a 
partici pa nt u n der g oi n g re -scree ni n g if 1) t he e n d osc o p y data was o btai ne d  u p t o 3 m o nt hs 
pri or t o re -scree ni n g, 2) t he partici pa nt has c o nti n ue d G F D  a n d 3) t he partici pa nt has n ot 
u n der g o ne a G C.  
8. 2. 4. 1.  Hist ol o gic al Assess me nts  
Tiss ue sa m ples c ollecte d d uri n g bi o ps y as s pecifie d i n t he S o A  will be a nal yze d f or 
hist ol o gical state (i ncl u di n g, b ut n ot li mite d t o: vill us hei g ht , cr y pt de pt h, Mars h sc ore, a n d 
I E L c o u nt ). Hist ol o g y will be ce ntrall y rea d b y q ualifie d raters. 
It is a ntici pate d t hat a p pr o xi matel y 5 0 % of patie nts will ha ve baseli ne hist ol o g y t hat ma y be 
e xcl usi o nar y f or t his trial  ( V h:C d < 2. 3) . (A del ma n et al , 2 0 1 8 ). A baseli ne V h: C d rati o  c ut off  
of 2. 3 was c h ose n t o e ns ure t hat partici pa nt s wit h  e vi de nce of m ore m o derate t o se ver e 
vill o us atr o p h y are n ot e nr olle d i nt o t he st u d y.  
Ma na ge me nt of I nci de ntal Fi n di n gs  
A n i nci de ntal fi n di n g is o ne u n k n o w n t o t he partici pa nt  t hat has p ote ntial healt h or 
re pr o d ucti ve i m p orta nce, w hic h is disc o vere d u ne x pecte dl y i n t he c o urse of a researc h st u d y, 
b ut is u nrelate d t o t he p ur p ose a n d be y o n d t he ai ms of t he st u d y.  
Hist ol o g y fr o m E G D  bi o ps y  will be re vie we d b y a ce ntral re vie w facilit y. T he p ur p ose of t his 
re vie w is t o e val uate hist ol o g y  f or celiac disease . Ce ntral hist ol o gical  re vie w is n ot a 
c o m plete me dical re vie w of t he partici pa nt . If, d uri n g t he ce ntral re vie w pr ocess, a n 
u ne x pecte d o bser vati o n is i de ntifie d a n d t his fi n di n g c o ul d, i n t he o pi ni o n of t he ce ntral 
re vie wer, ha ve a si g nifica nt healt h or re pr o d ucti ve c o nse q ue nce, t his fi n di n g ma y be s hare d 
wit h t he st u d y s p o ns or or  s p o ns or’s desi g nee  f or discl os ure to t he PI. All f oll o w -u p testi n g 
a n d fi nal dia g n osis will be left t o t he discreti o n of t he me dical pr ofessi o nals at t he site or 
t h ose wit h a n e xisti n g p h ysician -partici pa nt relati o ns hi p. T he PI will be res p o nsi ble f or 
re p orti n g a n y A Es i de ntifie d fr o m i nci de ntal fi n di n gs as descri be d i n t he A E re p orti n g 
secti o n. I de ntificati o n of s uc h i nci de ntal fi n di n gs d uri n g t he ce ntral re vie w pr ocess s h o ul d 
n ot be e x pecte d, a n d t he site mai ntai ns res p o nsi bilit y f or perf or mi n g a ge neral safet y re vie w 
of all hist ol o g y  as per site pr ot oc ols.  
8. 3.  S afet y Assess me nts  
S afet y will be assesse d t hr o u g h t he m o nit ori n g of A Es, cli nical si g ns a n d s y m pt o ms, vital 
si g ns a n d cli nical la b orat or y e val uati o ns.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 5 7  
All partici pa nts will be m o nit ore d c o nti n u o usl y f or A Es fr o m scree ni n g u ntil t he safet y 
f oll o w-u p  visit o n Da y 4 2 . A E se verit y will be assesse d usi n g t he N CI C T C A E v 6 . 0 or hi g her 
(see A p pe n di x 1 0 ). T he D S M B will re vie w c u m ulati ve safet y data peri o dicall y . A n y Gra de 4 
A Es ass esse d as relate d t o st u d y dr u g will res ult i n n otificati o n of t he re g ulat or y a ge ncies i n 
parallel wit h t he D S M B.  
Partici pa nts  will be m o nit ore d i n t he cli nic f or at least 4 h o urs f oll o wi n g I V st u d y dr u g 
a d mi nistrati o n  f or I R R (see A p pe n di x 9 ).  
I n relati o n t o partici pa nt safet y d uri n g t he C O VI D-1 9 pa n de mic, c urre nt nati o nal la ws a n d 
l ocal rec o m me n dati o ns s h o ul d be strictl y a d here d t o d uri n g t he st u d y.  
Pla n ne d ti me p oi nts f or all safet y assess me nts are pr o vi de d i n t he  S o A . U nsc he d ule d safet y 
meas ure me nts ma y be o btai ne d at a n y ti me d uri n g t he st u d y t o assess a n y percei ve d safet y 
iss ues. 
8. 3. 1.  I nci de nt al Gl ute n E x p os ure Assess me nt  
I nci de ntal gl ute n e x p os ure will be assesse d dail y as part of t he partici pa nt’s e Diar y. 
Assess me nt of a n y i nci de ntal gl ute n e x p os ure will be re vie we d at all st u d y visits.  
8. 3. 2.  Vit al Si g ns  
A n y u nt o war d vital si g n fi n di n gs t hat are i de ntifie d d uri n g t he acti ve c ollecti o n peri o d a n d 
meet t he defi niti o n of a n A E or S A E ( A p pe n di x 3 ) m ust be re p orte d acc or di n g t o t he 
pr o cesses i n Secti o ns 8. 4. 1  t o 8. 4. 3 . 
Vital si g ns will be m o nit ore d bef ore, d uri n g a n d after st u d y  i nter ve nti o n i nf usi o ns t o assess 
f or I R R (see A p pe n di x 9 ). 
Vital si g ns will be ta ke n bef ore c ollecti o n of  la b orat or y tests. Hei g ht a n d wei g ht will als o be 
meas ure d a n d rec or de d at scree ni n g o nl y a n d ca pt ure d o n t he C R F.  
B P  a n d P R  assess me nt c o nsists of a si n gle meas ure of P R a n d a si n gle B P. Sitti n g B P  a n d P R  
meas ure me nt will be assesse d wit h a c o m pletel y a ut o mate d de vice. Ma n ual tec h ni q ues will 
be use d o nl y if a n a ut o mate d de vice is n ot a vaila ble.  B P  a n d P R  meas ure me nt s h o ul d be 
prece de d b y at least 5 mi n utes of rest wit h  t he partici pa nt i n a sitti n g p ositi o n, i n a q uiet 
setti n g wit h o ut distracti o ns.  
Oral  te m perat ure a n d res pirat or y rate will be assesse d . Te m perat ure a n d res pirat or y rate 
fi n di n gs c ollecte d d uri n g t he st u d y will be c o nsi dere d s o urce data a n d will n ot be re q uire d t o 
be re p orte d, u nless ot her wise n ote d.  
8. 3. 3.  Electr oc ar di o gr a ms  
A s ta n dar d 1 2 -lea d EC G utilizi n g li m b lea ds ( wit h a 1 0 -sec o n d r h yt h m stri p) s h o ul d be 
c ollecte d at scree ni n g usi n g a n E C G mac hi ne t hat a ut o maticall y calc ulates t he H R  a n d 
meas ures P R  i nter val, Q T i nter val, Q TcF , a n d Q R S c o m ple x . Alter nati ve lea d place me nt 
met h o d ol o g y usi n g t ors o lea ds (e g , Mas o n -Li kar) s h o ul d n ot be use d  gi ve n t he p ote ntial ris k 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 5 8  
of discre pa ncies wit h E C Gs ac q uire d usi n g sta n dar d li m b lea d place me nt. T he E C G s h o ul d 
be perf or me d pri or t o bl o o d dra ws a n d after t he partici pa nt  has reste d q uietl y f or at least 
5  mi n utes i n a s u pi ne p ositi o n.  
U nsc he d ule d E C Gs are per mitte d per t he i n vesti gat or’s discreti o n.  
I n s o me cases, it ma y be a p pr o priate t o re peat a b n or mal E C Gs t o r ule o ut i m pr o per lea d 
place me nt as c o ntri b uti n g t o t he E C G a b n or malit y. If a mac hi ne -rea d Q Tc val ue is 
pr ol o n ge d, as defi ne d a b o ve, re peat meas ure me nts ma y n ot be necessar y if a q ualifie d 
me dical pr o vi der ’s i nter pretati o n deter mi nes t hat t he Q TcF  val ues are i n t he acce pta ble 
ra n ge. 
E C G val ues of p ote ntial cli nical c o ncer n are liste d i n A p pe n di x 8 . 
8. 3. 4.  Cli nic al S afet y L a b or at or y Assess me nts   
See A p pe n di x 2  f or t he list of cli nical safet y la b orat or y tests t o be perf or me d a n d t he S o A  f or 
t he ti mi n g a n d fre q ue nc y. All pr ot oc ol re q uire d - la b orat or y assess me nts, as defi ne d i n 
A p pe n di x 2 , m ust be c o n d ucte d i n acc or da nce wit h t he la b orat or y ma n ual a n d t he S o A . 
U nsc he d ule d cli nical la b orat or y meas ure me nts ma y be o btai ne d at a n y ti me d uri n g t he st u d y 
t o assess a n y percei ve d safet y iss ues.  
T he i n vesti gat or m ust re vie w t he la b orat or y re p ort, d oc u me nt t his re vie w, a n d rec or d a n y 
cli nicall y si g nifica nt c ha n ges occ urri n g d uri n g t he st u d y i n t he A E secti o n of t he C R F.  
Cli nicall y si g nifica nt a b n or mal la b orat or y test fi n di n gs are t h ose t hat are n ot ass ociate d wit h 
a n y u n derl yi n g disease, u nless j u d ge d b y t he i n vesti gat or t o be m ore se vere t ha n e x pecte d f or 
t he partici pa nt's c o n diti o n. 
All la b orat or y tests wit h val ues c o nsi dere d cli nicall y si g nifica nt a n d a b n or mal d uri n g 
partici pati o n i n t he st u d y or wit hi n t he f oll o w-u p peri o d after t he last d ose of st u d y 
i nter ve nti o n s h o ul d be re peate d u ntil t he val ues ret ur n t o n or mal or baseli ne or are n o l o n ger 
c o nsi dere d cli nicall y si g nifica nt b y t he i n vesti gat or or st u d y me dical m o nit or.  
If s uc h val ues d o n ot ret ur n t o n or mal/ baseli ne wit hi n a peri o d of ti me j u d ge d reas o na ble b y 
t he i n vesti gat or, t he eti ol o g y s h o ul d be i de ntifie d a n d Pfizer  n otifie d.   
See A p pe n di x 6  f or s u g geste d acti o ns a n d f oll o w-u p assess me nts i n t he e ve nt of p ote ntial 
DI LI . 
See A p pe n di x 7  f or i nstr ucti o ns f or la b orat or y testi n g t o m o nit or ki d ne y f u ncti o n a n d 
re p orti n g la b orat or y test a b n or malities. 
8. 3. 4. 1.  Alter n ati ve F acilities f or Cli nic al S afet y L a b or at or y Assess me nt  
Pr ot oc ol -s pecifie d safet y la b orat or y e val uati o ns will be  c o n d ucte d at a ce ntral la b orat or y. 
N o n -pr ot oc ol -s pecifie d la b orat or y e val uati o ns as or dere d b y t he i n vesti gat or ma y be 
c o n d ucte d at a l ocal la b orat or y.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 5 9  
If a l ocal la b orat or y is use d, q ualifie d st u d y site pers o n nel m ust or der, recei ve, a n d re vie w 
res ults. Site staff m ust c ollect  t he l ocal la b orat or y refere nce ra n ges a n d certificati o ns/  
accre ditati o ns f or fili n g at t he site.  La b orat or y test res ults are t o be pr o vi de d t o t he site staff 
as s o o n as p ossi ble . T he l ocal la b orat or y re p orts s h o ul d be file d i n t he partici pa nt’s s o urce 
d oc u me nts/ me dical rec or ds. Rele va nt data fr o m t he l ocal la b orat or y re p ort s h o ul d 
be rec or de d o n t he  C R F.  
8. 3. 5.  P h ysic al E x a mi n ati o ns  
A c o m plete p h ysical e xa mi nati o n will i ncl u de, at a mi ni m u m, assess me nts of t he 
car di o vasc ular, res pirat or y, gastr oi ntesti nal, a n d ne ur ol o gical s yste ms.  
I n vesti gat ors s h o ul d pa y s pecial atte nti o n t o cli nical si g ns relate d t o pre vi o us seri o us 
ill nesses.  
P h ysical e xa mi nati o n fi n di n gs c ollecte d d uri n g t he st u d y will be c o nsi dere d s o urce rec or d 
a n d will n ot be re q uire d t o be re p orte d, u nless ot her wise n ote d. A n y u nt o war d p h ysical 
e xa mi nati o n fi n di n gs t hat are i de ntifie d d uri n g t he acti ve c ollecti o n peri o d a n d meet t he 
defi niti o n of a n A E or S A E ( A p pe n di x 3 ) m ust be re p orte d acc or di n g t o t he pr ocesses i n 
Secti o ns 8. 4. 1  t o 8. 4. 3 . 
8. 3. 6.  Pre g n a nc y Testi n g  
A ser u m pre g na nc y test is re q uire d at scree ni n g. F oll o wi n g scree ni n g , pre g na nc y tests ma y 
be uri ne or ser u m tests,  a n d m ust ha ve a se nsiti vit y of at least 2 5  mI U/ m L. Pre g na nc y tests 
will be perf or me d i n W O C B P  (see A p pe n di x 4 ) at t he ti mes liste d i n t he  S o A . F oll o wi n g a 
ne gati ve pre g na nc y test res ult at scree ni n g, a p pr o priate c o ntrace pti o n m ust be c o m me nce d 
a n d a sec o n d ne gati ve pre g na nc y test res ult will be re q uire d at t he baseli ne visit pri or  t o t he 
starti n g t he st u d y i nter ve nti o n. Pre g na nc y tests will als o be d o ne w he ne ver 1 me nstr ual c ycle 
is misse d d uri n g t he acti ve treat me nt peri o d ( or w he n p ote ntial pre g na nc y is ot her wise 
s us pecte d) a n d at t he e n d of t he st u d y. Pre g na nc y tests ma y als o be re peate d if re q ueste d b y 
I R Bs/ E Cs or if re q uire d b y l ocal re g ulati o ns. If a uri ne test ca n n ot be c o nfir me d as ne gati ve 
(e g, a n a m bi g u o us res ult), a ser u m pre g na nc y test is re q uire d. I n s uc h cases, t he partici pa nt 
m ust be e xcl u de d if t he ser u m pre g na nc y re s ult is p ositi ve. 
8. 4.  A d verse E ve nts , Seri o us A d verse E ve nts , a n d Ot her S afet y Re p orti n g 
T he defi niti o ns of a n A E a n d a n S A E ca n be f o u n d i n  A p pe n di x 3 . 
A Es ma y arise fr o m s y m pt o ms or ot her c o m plai nts re p orte d t o t he i n vesti gat or b y t he 
partici pa nt ( or, w he n a p pr o priate, b y a care gi ver, s urr o gate, or t he partici pa nt's le gall y 
a ut h orize d re prese ntati ve), or t he y ma y arise fr o m cli nical fi n di n gs of t he in vesti gat or or 
ot her healt hcare pr o vi ders (cli nical si g ns, test res ults, etc).  
T he i n vesti gat or a n d a n y q ualifie d desi g nees are res p o nsi ble f or detecti n g, d oc u me nti n g, a n d 
rec or di n g e ve nts t hat meet t he defi niti o n of a n A E or S A E a n d re mai n res p o nsi ble t o p urs ue 
a n d o btai n a de q uate i nf or mati o n b ot h t o deter mi ne t he o utc o me a n d t o ass ess w het her t he 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 6 0  
e ve nt  meets t he criteria f or classificati o n as a n S A E or ca use d t he partici pa nt t o disc o nti n ue 
t he st u d y i nter ve nti o n (see Secti o n 7. 1 ).  
D uri n g t he acti ve c ollecti o n peri o d as descri be d i n Secti o n 8. 4. 1 , eac h partici pa nt  will be 
q uesti o ne d a b o ut t he occ urre nce of A Es i n a n o nlea di n g ma n ner.  
I n a d diti o n, t he i n vesti gat or ma y be re q ueste d b y t he s p o ns or or desi g nee t o o btai n s pecific 
f oll o w -u p i nf or mati o n i n a n e x pe dite d fas hi o n.  
8. 4. 1.  Ti me Peri o d a n d Fre q ue nc y f or C ollecti n g A E a n d S A E I nf or m ati o n  
T he ti me peri o d f or acti vel y eliciti n g a n d c ollecti n g A Es a n d S A Es (“acti ve c ollecti o n 
peri o d”) f or eac h partici pa nt  be gi ns fr o m t he ti me t he partici pa nt  pr o vi des i nf or me d c o nse nt, 
w hic h is o btai ne d bef ore u n der g oi n g a n y st u d y  -relate d pr oce d ure a n d/ or recei vi n g st u d y 
i nter ve nti o n, t hr o u g h a n d i ncl u di n g a mi ni m u m of 2 8 cale n dar da ys , e xce pt as i n dicate d 
bel o w , after t he last a d mi nistrati o n of t he st u d y i nter ve nti o n.  
F oll o w -u p b y t he i n vesti gat or c o nti n ues t hr o u g h o ut t he acti ve c ollecti o n peri o d a n d u ntil t he 
A E or S A E  or its se q uelae res ol ve or sta bilize at a le vel acce pta ble t o t he i n vesti gat or.  
W he n a cli nicall y si g nifica nt A E re mai ns o n g oi n g at t he e n d of t he acti ve c ollecti o n peri o d, 
f oll o w-u p b y t he i n vesti gat or c o nti n ues u ntil t he A E or S A E or its se q uelae res ol ve or 
sta bilize at a le vel acce pta ble t o t he i n vesti gat or a n d t he s p o ns or c o nc urs wit h t hat 
assess me nt.  
F or partici pa nts w h o are scree n fail ures, t he acti ve c ollecti o n peri o d e n ds w he n scree n fail ure 
stat us is deter mi ne d. 
If t he partici pa nt wit h dra ws fr o m t he st u d y a n d als o wit h dra ws c o nse nt f or t he c ollecti o n of 
f ut ure i nf or mati o n, t he acti ve c ollecti o n peri o d e n ds w he n c o nse nt is wit h dra w n. 
If a partici pa nt per ma ne ntl y  disc o nti n ues or te m p oraril y disc o nti n ues st u d y i nter ve nti o n 
beca use of  a n A E or S A E, t he A E or S A E m ust be rec or de d o n t he C R F a n d t he S A E 
re p orte d usi n g t he C T S A E Re p ort F or m.  
I n vesti gat ors are n ot o bli gate d t o acti vel y see k i nf or mati o n o n A E s or S A E s after t he 
partici pa nt has c o ncl u de d st u d y partici pati o n. H o we ver, if t he i n vesti gat or lear ns of a n y S A E, 
i ncl u di n g a deat h, at a n y ti me after a partici pa nt has co ncl u de d st u d y partici pati o n , a n d t he y 
c o nsi der t he e ve nt t o be reas o na bl y relate d t o t he st u d y i nter ve nti o n, t he i n vesti gat or m ust 
pr o m ptl y re p ort t he S A E t o Pfizer  S afet y usi n g t he C T S A E Re p ort F or m . 
8. 4. 1. 1.  Re p orti n g S A Es t o t he Pfizer S afet y  
All S A Es occ urri n g i n a partici pa nt  d uri n g t he acti ve c ollecti o n peri o d as descri be d i n  
Secti o n 8. 4. 1  are re p orte d t o t he Pfizer Safet y  o n t he C T S A E Re p ort F or m i m me diatel y 
u p o n a ware ness a n d u n der n o circ u msta nce s h o ul d t his e xcee d 2 4 h o urs, as i n dicate d i n 
A p pe n di x  3 . T he i n vesti gat or will s u b mit a n y u p date d S A E data t o Pfizer S afet y wit hi n 
2 4  h o urs of it s bei n g a vaila ble.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 6 1  
8. 4. 1. 2.  Rec or di n g N o nseri o us A Es a n d S A Es o n t he C R F  
All n o nseri o us A Es a n d S A Es occ urri n g i n a partici pa nt d uri n g t he acti ve c ollecti o n peri o d , 
w hic h be gi ns after o btai ni n g i nf or me d c o nse nt  as descri be d i n  Secti o n 8. 4. 1 , will be rec or de d 
o n t he A E secti o n of t he C R F.   
T he i n vesti gat or is t o rec or d o n t he C R F all directl y o bser ve d a n d all s p o nta ne o usl y re p orte d 
A Es a n d S A Es re p orte d b y t he partici pa nt.  
As part of o n g oi n g safet y re vie ws c o n d ucte d b y t he s p o ns or, a n y n o nseri o us A E t hat is 
deter mi ne d b y t he s p o ns or t o be seri o us will be re p orte d b y Pfizer S afet y as a n S A E. T o 
assist i n t he deter mi nati o n of case seri o us ness, f urt her i nf or mati o n ma y be re q ueste d fr o m t he 
i n vesti gat or t o pr o vi de clarit y a n d u n dersta n di n g of t he e ve nt i n t he c o nte xt of t he cli nical 
st u d y. 
8. 4. 2.  Met h o d of Detecti n g A Es a n d S A Es  
T he met h o d of rec or di n g, e val uati n g, a n d assessi n g ca usalit y of A E s a n d S A Es a n d t he 
pr oce d ures f or c o m pleti n g a n d tra ns mitti n g S A E re p orts are pr o vi de d i n  A p pe n di x 3 . 
Care will be ta ke n n ot t o i ntr o d uce bias w he n detecti n g A Es a n d/ or S A Es.  O pe n -e n de d a n d 
n o nlea di n g ver bal q uesti o ni n g of t he partici pa nt is t he preferre d met h o d t o i n q uire a b o ut 
A E  occ urre nces.  
8. 4. 3.  F oll o w -U p of A Es a n d S A Es  
After t he i nitial A E  or S A E re p ort, t he i n vesti gat or is re q uire d t o pr oacti vel y f oll o w eac h 
partici pa nt at s u bse q ue nt visits/c o ntacts. F or eac h e ve nt, t he i n vesti gat or m ust p urs ue a n d 
o btai n a de q uate i nf or mati o n u ntil res ol uti o n, sta bilizati o n, t he e ve nt is ot her wise e x plai ne d, 
o r t he partici pa nt is l ost t o f oll o w-u p (as defi ne d i n Secti o n 7. 3 ). 
I n ge neral, f oll o w-u p i nf or mati o n will i ncl u de a descri pti o n of t he e ve nt i n s ufficie nt detail t o 
all o w f or a c o m plete me dical assess me nt of t he case a n d i n de pe n de nt deter mi nati o n of 
p ossi ble ca usalit y. A n y i nf or mati o n rele va nt t o t he e ve nt, s uc h as c o nc o mita nt me dicati o ns 
an d ill nesses, m ust be pr o vi de d. I n t he case of a partici pa nt  deat h, a s u m mar y of a vaila ble 
a ut o ps y fi n di n gs m ust be s u b mitte d as s o o n as p ossi ble t o Pfizer S afet y.  
F urt her i nf or mati o n o n f oll o w -u p pr oce d ures is pr o vi de d  i n A p pe n di x 3 . 
8. 4. 4.  Re g ul at or y Re p orti n g Re q uire me nts f or S A Es  
Pr o m pt n otificati o n b y t he i n vesti gat or t o Pfizer S afet y of a n  S A E is esse ntial s o t hat le gal 
o bli gati o ns a n d et hical res p o nsi bilities t o war d t he safet y of partici pa nts a n d t he safet y of a 
st u d y i nter ve nti o n u n der cli nical i n vesti gati o n are met. 
T he s p o ns or  or s p o ns or’s  desi g nee  has a le gal res p o nsi bilit y t o n otif y b ot h t he l ocal 
re g ulat or y a ut h orit y a n d ot her re g ulat or y a ge ncies a b o ut t he safet y of a st u d y i nter ve nti o n 
u n der cli nical i n vesti gati o n.  T he s p o ns or  or s p o ns or’s desi g nee  will c o m pl y wit h 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 6 2  
c o u ntr y -s pecific re g ulat or y re q uire me nts relati n g t o safet y re p orti n g t o t he re g ulat or y 
a ut h orit y  (s uc h as t he U S F D A a n d E U E u dra Vi gila nce), I R Bs/ E Cs, a n d i n vesti gat ors. 
I n vesti gat or safet y re p orts m ust be pre pare d f or S U S A Rs acc or di n g t o l ocal re g ulat or y 
re q uire me nts a n d Pfizer S afet y p olic y a n d f or war de d t o i n vesti gat ors as necessar y.  
A n i n vesti gat or w h o recei ves S U S A R s or ot her s pecific safet y i nf or mati o n (e g, s u m mar y or 
listi n g of S A Es) fr o m Pfizer S afet y will re vie w a n d t he n file it al o n g wit h t he S R S D (s) f or 
t he st u d y a n d will n otif y t he I R B/ E C, if a p pr o priate acc or di n g t o l ocal re q uire me nts.  
8. 4. 5.  E n vir o n me nt al E x p os ure, E x p os ure D uri n g Pre g n a nc y or Bre astfee di n g, a n d 
Occ u p ati o n al E x p os ure  
E n vir o n me ntal e x p os ure occ urs w he n a pers o n n ot e nr olle d i n t he st u d y as a partici pa nt 
recei ves u n pla n ne d direct c o ntact wit h or e x p os ure t o t he st u d y i nter ve nti o n. S uc h e x p os ure 
ma y or ma y n ot lea d t o t he occ urre nce of a n A E or S A E. Pers o ns at ris k f or e n vir o n me ntal 
e x p os ure i ncl u de healt hcare pr o vi ders, fa mil y me m bers, a n d ot hers w h o ma y be e x p ose d . A n 
e n vir o n me ntal e x p os ure ma y i ncl u de  E D P, E D B , a n d occ u pati o nal e x p os ure . 
A n y s uc h ex p os ure s t o t he st u d y i nter ve nti on  u n der st u d y are re p orta ble t o t he Pfizer  wit hi n 
2 4 h o urs of i n vesti gat or a ware ness.  
8. 4. 5. 1.  E x p os ure D uri n g pre g n a nc y  
A n E D P occ urs if:  
•  A fe male p artici pa nt is f o u n d t o be pre g na nt w hile  recei vi n g or after disc o nti n ui n g 
st u d y i nter ve nti o n d uri n g t he ma n dat or y c o ntrace pti o n peri o d (see A p pe n di x 4 ).  
•  A male partici pa nt w h o is recei vi n g or has disc o nti n ue d st u d y i nter ve nti o n 
i nse mi nates a fe male part ner d uri n g t he ma n dat or y c o ntrace pti o n peri o d (see 
A p p en di x 4 ). 
•  A fe male n o n partici pa nt is f o u n d t o be pre g na nt w hile bei n g e x p ose d or ha vi n g 
bee n e x p ose d t o st u d y i nter ve nti o n beca use of e n vir o n me ntal e x p os ure. Bel o w are 
e xa m ples of e n vir o n me ntal E D P if t he y occ ur wit hi n 2 1 da ys after e x p os ure:  
•  A fe male fa mil y me m ber or healt hcare pr o vi der  re p orts t hat s he is pre g na nt 
after ha vi n g bee n e x p ose d t o t he st u d y i nter ve nti o n b y i n gesti o n, i n halati o n, or 
s ki n c o ntact. 
•  A male fa mil y me m ber or healt hcare pr o vi der  w h o has bee n e x p ose d t o t he 
st u d y i nter ve nti o n b y i n gesti o n, i n halati o n, or s ki n c o ntact t he n i nse mi nates 
his fe male part ner pri or t o or ar o u n d t he ti me of c o nce pti o n . 
T he i n vesti gat or m ust re p ort E D P t o Pfizer  wit hi n 2 4 h o urs of t he i n vesti gat or’s a ware ness, 
irres pecti ve of w het her a n S A E has occ urre d. T he i nitial i nf or mati o n s u b mitte d s h o ul d 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 6 3  
i ncl u de t he a ntici pate d date of deli ver y (see bel o w f or i nf or mati o n relate d t o ter mi nati o n of 
pre g na nc y).  
•   If E D P occ urs i n a partici pa nt/partici pa nt’s part ner, t he i n vesti gat or m ust re p ort 
t his i nf or mati o n t o Pfizer  o n t he C T S A E Re p ort F or m a n d a n E D P S u p ple me ntal 
F or m, re gar dless of w het her a n S A E has occ urre d.  Details of t he pre g na nc y will 
be c ollecte d after t he start of st u d y i nter ve nti o n a n d u ntil 1 2 wee ks  after t he last 
d ose .  
•  If E D P occ urs i n t he setti n g of e n vir o n me ntal e x p os ure, t he i n vesti gat or m ust 
re p ort i nf or mati o n t o Pfizer  usi n g t he C T S A E Re p ort F or m a n d E D P 
S u p ple me ntal F or m. Si nce t he e x p os ure i nf or mati o n d oes n ot pertai n t o t he 
partici pa nt e nr olle d i n t he st u d y, t he i nf or mati o n is n ot rec or de d o n a C R F; 
h o we ver, a c o p y of t he c o m plete d C T S A E Re p ort F or m is mai ntai ne d i n t he 
i n vesti gat or site file. 
F oll o w -u p is c o n d ucte d t o o btai n ge neral i nf or mati o n o n t he pre g na nc y a n d its o utc o me f or 
all E D P re p orts wit h a n u n k n o w n o utc o me. T he i n vesti gat or will f oll o w t he pre g na nc y u ntil 
c o m pleti o n ( or u ntil pre g na nc y ter mi nati o n) a n d n otif y Pf izer of t he o utc o me as a f oll o w -u p 
t o t he i nitial-E D P S u p ple me ntal F or m. I n t he case of a li ve birt h, t he str uct ural i nte grit y of 
t he ne o nate ca n be assesse d at t he ti me of birt h. I n t he e ve nt of a ter mi nati o n, t he reas o n(s) 
f or ter mi nati o n s h o ul d be s pecifie d a n d, if cli nicall y p ossi ble, t he str uct ural i nte grit y of t he 
ter mi nate d fet us s h o ul d be assesse d b y gr oss vis ual i ns pecti o n ( u nless pre pr oce d ure test 
fi n di n gs are c o ncl usi ve f or a c o n ge nital a n o mal y a n d t he fi n di n gs are re p orte d). 
A b n or mal pre g na nc y o utc o mes are c o nsi dere d S A Es. If t he o utc o me of t he pre g na nc y meets 
t he criteria f or a n S A E (ie, ect o pic pre g na nc y, s p o nta ne o us a b orti o n, i ntra uteri ne fetal 
de mise, ne o natal deat h, or c o n ge nital a n o mal y i n a li ve-b or n ba b y, a ter mi nate d fet us ), t he 
i n vesti gat or s h o ul d f oll o w t he pr oce d ures f or re p orti n g S A Es. A d diti o nal i nf or mati o n a b o ut 
pre g na nc y o utc o mes t hat are re p orte d t o Pfizer  as S A Es f oll o ws:  
•  
S p o nta ne o us a b orti o n i ncl u d i n g miscarria ge a n d misse d a b orti o n  s h o ul d be 
re p orte d as a n S A E; 
•  
Ne o natal deat hs t hat occ ur wit hi n 1  m o nt h of birt h s h o ul d be re p orte d, wit h o ut 
re gar d t o ca usalit y, as S A Es. I n a d diti o n, i nfa nt deat hs after 1 m o nt h s h o ul d be 
re p orte d as S A Es w he n t he i n vesti gat or assesses t he i nfa nt deat h as relate d or 
p ossi bl y relate d t o e x p os ure t o t he st u d y i nter ve nti o n.  
A d diti o nal i nf or mati o n re gar di n g t he E D P ma y be re q ueste d b y Pfizer . F urt her f oll o w-u p of 
birt h o utc o mes will be ha n dle d o n a case -b y -case basis (e g, f oll o w --u p o n preter m i nfa nts t o 
i de ntif y de vel o p me ntal dela ys). I n t he case of pater nal e x p os ure, t he i n vesti gat or will pr o vi de 
t he partici pa nt wit h t he Pre g na nt Part ner Release of I nf or mati o n F or m t o deli ver t o his 
part ner. T he i n vesti gat or m ust d oc u me nt i n t he s o urce d oc u me nts t hat t he partici pa nt was 
gi ve n t he Pre g n a nt Part ner Release of I nf or mati o n F or m t o pr o vi de t o his part ner.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 6 4  
8. 4. 5. 2.  E x p os ure D uri n g Bre astfee di n g  
A n E D B  occ urs if:   
•  A fe male partici pa nt is f o u n d t o be breastfee di n g w hile recei vi n g or after 
disc o nti n ui n g st u d y i nter ve nti o n  d uri n g t he ma n dat or y c o ntrace pti o n peri o d (see 
A p pe n di x 4 ).  
•  A fe male n o n partici pa nt  is f o u n d t o be breastfee di n g w hile bei n g e x p ose d or 
ha vi n g bee n e x p ose d t o st u d y i nter ve nti o n (ie, e n vir o n me ntal e x p os ure)  wit hi n t he 
last 2 1 da ys. A n e xa m ple of e n vir o n me ntal E D B  is a fe male fa mil y me m ber or 
healt hcare pr o vi der w h o re p orts t hat s he is breastfee di n g after ha vi n g bee n 
e x p ose d t o t he st u d y i nter ve nti o n  b y  i n gesti o n, i n halati o n, or s ki n c o ntact.  
T he i n vesti gat or m ust re p ort E D B  t o Pfizer  wit hi n 2 4 h o urs of t he i n vesti gat or’s a ware ness, 
irres pecti ve of w het her a n S A E has occ urre d. T he i nf or mati o n m ust be re p orte d usi n g t he C T 
S A E Re p ort F or m. W he n E D B  occ urs i n t he setti n g of e n vir o n me ntal e x p os ure, t he e x p os ure 
i nf or mati o n d oes n ot pertai n t o t he partici pa nt e nr olle d i n t he st u d y, s o t he i nf or mati o n is n ot 
rec or de d o n a C R F. H o we ver, a c o p y of t he c o m plete d C T S A E Re p ort F or m is mai ntai ne d i n 
t he i n vesti gat or site file. 
8. 4. 5. 3.  Occ u p ati o n al E x p os ure  
T he i n vesti gat or m ust re p ort a n y i nsta nce of occ u pati o nal e x p os ure  t o Pfizer  wit hi n 2 4 h o urs 
of t he i n vesti gat or’s a ware ness  usi n g t he C T S A E Re p ort F or m , re gar dless of w het her t here 
is a n ass ociate d S A E. Si nce t he i nf or mati o n a b o ut t he occ u pati o nal e x p os ure  d oes n ot pertai n 
t o a partici pa nt  e nr olle d i n t he st u d y, t he i nf or mati o n is n ot rec or de d o n a C R F; h o we ver, a 
c o p y of t he c o m plete d C T S A E Re p ort F or m m ust be mai ntai ne d i n t he i n vesti gat or site file . 
8. 4. 6.  C ar di o v asc ul ar a n d De at h E ve nts  
N ot a p plica ble.  
8. 4. 7.  Dise ase -Rel ate d E ve nts a n d/ or Dise ase -Rel ate d O utc o mes N ot Q u alif yi n g as A Es 
or S A Es  
N ot a p plica ble.  
8. 4. 8.  A d verse E ve nts of S peci al I nterest  
N ot a p plica ble.  
8. 4. 8. 1.  L ac k of Effic ac y  
T he i n vesti gat or m ust re p ort si g ns, s y m pt o ms, a n d/ or cli nical se q uelae res ulti n g fr o m lac k of 
efficac y. Lac k of efficac y or fail ure of e x pecte d p har mac ol o gical acti o n is re p orta ble t o Pfizer  
o nl y if ass oci ate d wit h a n S A E .  
8. 4. 9.  Me dic al De vice Deficie ncies  
N ot a p plica ble.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 6 5  
8. 4. 1 0.  Me dic ati o n Err ors  
Me dicati o n err ors ma y res ult fr o m t he a d mi nistrati o n or c o ns u m pti o n of t he st u d y 
i nter ve nti o n b y t he wr o n g partici pa nt , or at t he wr o n g ti me, or at t he wr o n g d osa ge stre n gt h. 
Me dicati o n err ors are rec or de d a n d re p orte d as f oll o ws:  
Rec or de d o n t he 
Me dic ati o n Err or P a ge  
of t he C R F  
Rec or de d o n t he  
A d verse E ve nt P a ge  
of t he C R F  
Re p orte d o n t he C T S A E 
Re p ort F or m t o Pfizer 
S afet y  Wit hi n 2 4 H o urs of 
A w are ness  
All (re gar dless of w het her 
ass ociate d wit h a n A E)  
A n y A E or S A E ass ociate d 
wit h t he me dicati o n err or  
O nl y if ass ociate d wit h a n 
S A E  
 
Me dicati o n err ors i ncl u de : 
•  
Me dicati o n err ors i n v ol vi n g partici pa nt  e x p os ure t o t he st u d y i nter ve nti o n; 
•  
P ote ntial me dicati o n err ors or uses o utsi de of w hat is f oresee n i n t he pr ot oc ol 
t hat d o or d o n ot i n v ol ve t he st u d y partici pa nt . 
•  
A d mi nistrati o n of a q ua ntit y of st u d y i nter ve nti o n per a d mi nistrati o n or 
c u m ulati ve, w hic h is a b o ve t he ma xi m u m d ose acc or di n g t o t he pr ot oc ol . 
•  
U ni nte nti o nal err or i n dis pe nsi n g or a d mi nistrati o n of st u d y i nter ve nti o n n ot i n 
acc or da nce wit h t he pr ot oc ol.  
W het her or n ot t he me dicati o n err or is acc o m pa nie d b y a n A E, as deter mi ne d b y t he 
i n vesti gat or, s uc h me dicati o n err or s occ urri n g t o a st u d y partici pa nt  are rec or de d o n t he 
me dicati o n err or pa ge of t he C R F w hic h is a s pecific versi o n of t he A E pa ge a n d, if 
a p plica ble, a n y ass ociate d seri o us a n d n o nseri o us  A Es , are rec or de d o n t he A E pa ge of t he 
C R F.   
I n t he e ve nt of a me dicati o n d osi n g err or, Pfizer  s h o ul d be n otifie d wit hi n 2 4 h o urs . 
Me dicati o n err ors s h o ul d be re p orte d t o t he Pfizer  wit hi n 2 4 h o urs o n a C T S A E Re p ort F or m  
o nl y w he n ass oci ate d wit h a n S A E.  
8. 5.  P h ar m ac o ki netics  
Bl o o d sa m ples will be c ollecte d f or meas ure me nt of plas ma  c o nce ntrati o ns of K A N -1 0 1  as 
s pecifie d i n t he S o A . I nstr ucti o ns f or t he c ollecti o n a n d ha n dli n g of bi ol o gical sa m ples will 
be pr o vi de d i n t he la b orat or y ma n ual. T he act ual date a n d ti me ( 2 4 -h o ur  cl oc k ti me) of eac h 
sa m ple will be rec or de d. Sa m ples c ollecte d f or meas ure me nt of plas ma c o nce ntrati o ns of 
st u d y i nter ve nti o n will be a nal yze d usi n g a vali date d a nal ytical met h o d i n c o m plia nce wit h 
a p plica ble S O Ps.   
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 6 6  
T he act ual ti mes f or P K assess me nt ma y c ha n ge, a n d if nee de d, a d diti o nal P K sa m ples ma y 
be ta ke n at ti mes s pecifie d b y sp o ns or  or desi g nee , pr o vi de d t he t otal bl o o d v ol u me ta ke n 
d uri n g t he st u d y d oes n ot e xcee d 5 5 0 m L d uri n g a n y peri o d of 5 6 c o nsec uti ve da ys. All 
eff orts will be ma de t o o btai n t he sa m ples at t he e xact n o mi nal ti me relati ve t o d osi n g. 
C ollecti o n of sa m ples wit hi n 2  mi n utes f or sa m ple s t hat are pla n ne d at less t ha n 1  h o ur, a n d 
wit hi n 5 mi n utes  f or sa m ples pla n ne d bet wee n 1 -7  h o urs after d ose a d mi nistrati o n of t he 
n o mi nal ti me res pecti vel y relati ve t o d osi n g will n ot be ca pt ure d as a pr ot oc ol de viati o n, as 
l o n g as t he e xact ti me of t he c ollecti o n is n ote d o n t he s o urce d oc u me nt a n d t he C R F/ D C T.  
Sa m ples will be use d t o e val uate t he P K of K A N -1 0 1. Sa m ples c ollecte d f or a nal yses of 
K A N -1 0 1 plas ma c o nce ntrati o n ma y als o be use d t o e val uate safet y or efficac y as pects 
relate d t o c o ncer ns arisi n g d uri n g or after t he st u d y, f or meta b olite i de ntificati o n a n d/ or 
e val uati o n of t he bi oa nal ytical met h o d, or f or ot her i nter nal e x pl orat or y p ur p oses, a n d n ot 
re p orte d i n t he C S R. 
T he P K sa m ples m ust be pr ocesse d a n d s hi p pe d as i n dicate d i n t he i nstr ucti o ns pr o vi de d t o 
t he i n vesti gat or site t o mai ntai n sa m ple i nte grit y. A n y de viati o ns fr o m t he P K sa m ple 
ha n dli n g pr oce d ure (e g, sa m ple c ollecti o n a n d pr ocessi n g ste ps, i nteri m st ora ge or s hi p pi n g 
c o n diti o ns), i ncl u di n g a n y acti o ns ta ke n, m ust be d oc u me nte d a n d re p orte d t o Pfizer . O n a 
case-b y -case basis, t he s p o ns or  or desi g nee  ma y ma ke a deter mi nati o n as t o w het her sa m ple 
inte grit y has bee n c o m pr o mise d.  
Ge netic a nal yses will n ot be perf or me d o n t hese w h ole bl o o d sa m ples u nless c o nse nt f or t his 
was i ncl u de d i n t he i nf or me d c o nse nt. Partici pa nt c o nfi de ntialit y will be mai ntai ne d.  
Dr u g c o nce ntrati o n i nf or mati o n t hat ma y u n bli n d t he st u d y will n ot be re p orte d t o 
i n vesti gator  sites or bli n de d pers o n nel u ntil t he st u d y has bee n u n bli n de d. 
A n y c ha n ges i n t he ti mi n g or a d diti o n of ti me p oi nts f or a n y pla n ne d st u d y assess me nts m ust 
be d oc u me nte d a n d a p pr o ve d b y t he rele va nt st u d y tea m me m ber a n d t he n arc hi ve d i n t he 
s p o ns or a n d site st u d y files b ut will n ot c o nstit ute a pr ot oc ol a me n d me nt. T he I R B/ E C will 
be i nf or me d of a n y safet y iss ues t hat re q uire alterati o n of t he safet y m o nit ori n g sc he me or 
a me n d me nt of t he I C D.  
8. 6.  Ge netics  
8. 6. 1.  S pecifie d Ge netics  
T o deter mi ne st u d y eli gi bilit y, all partici pa nts will be assesse d via ce ntral la b orat or y f or 
H L A -D Q 2. 5 ge n ot y pe (see I ncl usi o n Criteria, Secti o n 5. 1 ). 
Details o n pr ocesses f or c ollecti o n a n d s hi p me nt of t hese sa m ples ca n be f o u n d i n t he st u d y 
la borat or y  ma n ual . 
8. 7.  Bi o m ar kers  
C ollecti o n of sa m ples f or bi o mar ker researc h is als o part of t his st u d y.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 6 7  
T he f oll o wi n g sa m ples f or bi o mar ker researc h are re q uire d a n d will be c ollecte d fr o m all 
partici pa nts i n t he st u d y at ti mes s pecifie d i n t he S o A : 
•  Plas ma  (i ncl u di n g f or p las ma I L-2 bi o mar ker efficac y assess me nt; see Secti o n 8. 2. 2 ). 
Plas ma sa m ples c ollecte d will be a nal yze d f or  c yt o ki ne res p o nses  i ncl u di n g b ut n ot li mite d t o 
I L-2 .  
Details o n pr ocesses f or c ollecti o n a n d s hi p me nt of t hese sa m ples ca n be f o u n d i n t he st u d y 
la b orat or y ma n ual. 
8. 7. 1.  Resi d u al Rese arc h S a m ples  f or Bi o m ar kers 
A n y re mai ni n g resi d ual sa m ples n ot use d f or pr ot oc ol-s pecifie d assess me nts will be retai n e d 
as l ocal re g ulati o ns a n d I R B/ E Cs all o w . 
•  Sa m ples i ncl u de, b ut are n ot li mite d t o:  
o  
Plas ma  
o  
Hist o pat h o l o g y sa m ples 
R esi d ual r esearc h sa m ples ma y be use d f or researc h relate d t o t he st u d y i nter ve nti o n(s) or 
celiac disease . Ge nes a n d ot her a nal ytes ( e g, pr otei ns, R N A, n o n dr u g meta b olites) ma y be 
st u die d usi n g t he resi d ual sa m ples.  
See A p pe n di x 5  f or inf or mati o n re gar di n g ge netic researc h . Details o n pr ocesses f or 
c ollecti o n a n d s hi p me nt of t hese sa m ples ca n be f o u n d i n t he st u d y la borat or y  ma n ual .  
8. 8.  I m m u n o ge nicit y Assess me nts 
Bl o o d sa m ples will be c ollecte d f or deter mi nati o n of A D A as s pecifie d i n t he S o A . 
I nstr ucti o ns f or t he c ollecti o n a n d ha n dli n g of bi ol o gical sa m ples will be pr o vi de d i n t he 
la b orat or y ma n ual. T he act ual date a n d ti me ( 2 4-h o ur cl oc k ti me) of eac h sa m ple will be 
rec or de d.  
Sa m ples c ollecte d f or deter mi nati o n of A D A ma y als o be use d f or a d diti o nal c haracterizati o n 
of t he i m m u ne res p o nse a n d/ or e val uati o n of t he bi oa nal ytical met h o d, or f or ot her i nter nal 
e x pl orat or y p ur p oses.  T hese data will be use d f or i nter nal e x pl orat or y p ur p oses.  
Ge netic a nal yses will n ot be perf or me d o n t hese w h ole bl o o d sa m ples u nless c o nse nt f or t his 
was i ncl u de d i n t he i nf or me d c o nse nt. Partici pa nt c o nfi de ntialit y will be mai ntai ne d.  
Sa m ples will be a nal yze d usi n g a vali date d a nal ytical met h o d i n c o m plia nce wit h a p plica ble 
S O Ps.  
T he i m m u n o ge nicit y sa m ples m ust be pr ocesse d a n d s hi p pe d as i n dicate d i n t he i nstr ucti o ns 
pr o vi de d t o t he i n vesti gat or site t o mai ntai n sa m ple i nte grit y. A n y de viati o ns fr o m t he 
i m m u n o ge nicit y sa m ple ha n dli n g pr oce d ure (e g, sa m ple c ollecti o n a n d pr ocessi n g ste ps, 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 6 8  
i nteri m st ora ge, or s hi p pi n g c o n diti o ns), i ncl u di n g a n y acti o ns ta ke n, m ust be d oc u me nte d 
a n d re p orte d t o Pfizer . O n a case -b y -case basis , t he s p o ns or ma y ma ke a deter mi nati o n as t o 
w het her sa m ple i nte grit y has bee n c o m pr o mise d.  
I m m u n o ge nicit y i nf or mati o n t hat ma y u n bli n d t he st u d y will n ot be re p orte d t o i n vesti gat or 
sites or bli n de d pers o n nel u ntil t he st u d y has bee n u n bli n de d. 
A n y c ha n ges i n t he ti mi n g or a d diti o n of ti me p oi nts f or a n y pla n ne d st u d y assess me nts m ust 
be d oc u me nte d a n d a p pr o ve d b y t he rele va nt st u d y tea m me m ber a n d t he n arc hi ve d i n t he 
s p o ns or a n d site st u d y files b ut will n ot c o nstit ute a pr ot oc ol a me n d me nt. T he I R B/ E C will 
be i nf or me d of a n y safet y iss ues t hat re q uire alterati o n of t he safet y m o nit ori n g sc he me or 
a me n d me nt of t he I C D.  
8. 9.  He alt h Ec o n o mics  
Healt h ec o n o mics will n ot be assesse d i n t his st u d y.  
9.  S T A TI S TI C A L C O N SI D E R A TI O N S  
Detaile d met h o d ol o g y f or s u m mar y a n d statistical a nal yses of t he data c ollecte d i n t his st u d y 
is o utli ne d here a n d f urt her detaile d i n t he S A P, w hic h will be mai ntai ne d b y t he s p o ns or  or 
s p o ns or’s desi g nee . T he S A P ma y m o dif y w hat is o utli ne d i n t he pr ot oc ol w here a p pr o priate; 
h o we ver, a n y maj or m o dificati o ns of t he pri mar y e n d p oi nt defi niti o ns or t heir a nal yses will 
als o be reflecte d i n a pr ot oc ol a me n d me nt. 
9. 1.  St atistic al H y p ot heses  
T he h y p ot heses f or t he pri mar y a n d sec o n dar y e n d p oi nts are:  
•  H 0: T he mea n val ues are t he sa me bet wee n t he treat me nt gr o u ps 
•  H 1: T he mea n val ues are n ot t he sa me bet wee n t he treat me nt gr o u ps 
9. 2.  Esti m a n ds  
9. 2. 1.  Pri m ar y Esti m a n d  
Esti ma n d 1 will be use d f or t he pri mar y e n d p oi nt mai n a nal ysis.  
Esti m a n d 1:  T he pri mar y esti ma n d is t he h y p ot hetical esti ma n d, w hic h esti mates t he 
treat me nt effect of K A N -1 0 1  vs place b o f or c ha n ge fr o m baseli ne i n t he rati o of V h: C d  u n der 
t he sce nari o of n o i nterc urre nt e ve nts. It i ncl u des t he f oll o wi n g 5  attri b utes:  
•  P o p ulati o n:  Partici pa nt s w h o recei ve all 3 d oses of st u d y i nter ve nti o n a n d c o m plete at 
least 7 da ys of G C ; 
•  Varia ble : t he rati o of V h: C d  c ha n ge fr o m baseli ne  t o Da y 2 9; 
•  Treat me nt c o n diti o n:  K A N -1 0 1  or place b o ; 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 6 9  
•  I nterc urre nt e ve nts: Pr o hi bite d me dicati o n. All data c ollecte d after a n y i nterc urre nt 
e ve nts will be e xcl u de d ; 
•  P o p ulati o n‑le vel s u m mar y:  T he L S M differe nce of t he  c ha n ge fr o m baseli ne i n 
V h: C d  bet wee n K A N -1 0 1 gr o u p a n d place b o .  
9. 2. 1. 1.  Sec o n d ar y Esti m a n ds  
Esti m a n d  2  is h y p ot hetical , w hic h esti mates t he treat me nt effect of K A N-1 0 1 c o m pare d wit h 
place b o  f or I L-2 u n der t he sce nari o of n o i nterc urre nt e ve nts . It i ncl u des t he f oll o wi n g 
5  attri b utes:   
•  P o p ulati o n:  Partici pa nt s w h o c o m plete  all 3 d oses of st u d y i nter ve nti o n a n d c o m plete 
at least 7 da ys of G C ; 
•  Varia ble : l o g tra nsf or me d I L-2 c ha n ge fr o m pre G C  t o p ost G C at Da y 1 5  (first da y of 
G C) ; 
•  Treat me nt c o n diti o n:  K A N -1 0 1  or place b o ; 
•  I nterc urre nt e ve nts: pr o hi bite d me dicati o n , i nc o m plete G C o n Da y 1 5. All data 
c ollecte d after a n y i nterc urre nt e ve nts will be e xcl u de d; 
•  P o p ulati o n -le vel s u m mar y: the L S M  differe nce (l o g tra nsf or me d) of t he c ha n ge fr o m 
pre G C t o p ost G C at Da y 1 5  (first da y of G C)  bet wee n K A N -1 0 1  gr o u p  a n d place b o . 
Esti m a n d 3  is t he h y p ot hetical esti ma n d, w hic h esti mates t he treat me nt effect of K A N-1 0 1 
vs place b o f or c ha n ge fr o m baseli ne i n d u o de nal I E L de nsit y u n der t he sce nari o of n o 
i nterc urre nt e ve nts. It i ncl u des t he f oll o wi n g 5 attri b utes: 
 
•  P o p ulati o n : Partici pa nts w h o c o m plete  all 3 d oses of st u d y i nter ve nti o n a n d c o m plete 
at least 7 da ys of G C ; 
•  Varia ble : I E L c ha n ge fr o m baseli ne t o Da y 4 2; 
•  Treat me nt c o n diti o ns : K A N-1 0 1 or place b o ; 
•  I nterc urre nt E ve nts: Pr o hi bite d me dicati o n. All data c ollecte d after a n y i nterc urre nt 
e ve nts will be e xcl u de d ; 
•  P o p ulati o n le vel s u m mar y : T he L S M differe nce of t he c ha n ge fr o m baseli ne i n I E L 
bet wee n K A N -1 0 1 a n d place b o.  
9. 2. 2.  M ulti plicit y A dj ust me nt  
T here is n o m ulti plicit y a dj ust me nt  f or m ulti ple e n d p oi nts. T he al p ha s pe n di n g f or t he 
pla n ne d i nteri m a nal ysis is descri be d i n t he I nteri m A nal ysis secti o n  (Secti o n 9. 5 ). 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 7 0  
9. 3.  A n al ysis  Sets  
F or p ur p oses of a nal ysis, t he f oll o wi n g a nal ysis sets  are defi ne d: 
P artici p a nt  A n al ysis Set  Descri pti o n  
E nr olle d  
All partici pa nts w h o si g n t he I C D. 
F ull a nal ysis set ( F A S) 
All partici pa nts w h o are ra n d o ml y assi g ne d t o st u d y 
i nter ve nti o n a n d recei ve all 3 d oses of st u d y i nter ve nti o n , a n d 
c o m plete at least 7 da ys of G C . Partici pa nts will be a nal yze d 
acc or di n g t o t he i nter ve nti o n t he y are ra n d o mize d. 
Per pr ot oc ol set ( P P S) 
T he P P S  will i ncl u de all partici pa nts fr o m t he F A S  w h o  
c o m plete all 1 4 da ys of G C  a n d bi o psies , a n d wit h o ut 
maj or pr ot oc ol vi olati o ns t hat mi g ht affect t he e val uati o n of 
t he effect of st u d y i nter ve nti o n o n t he pri mar y e n d p oi nt. 
T he P P S  will be use d i n se nsiti vit y a nal yses of t he pri mar y 
a n d sec o n dar y e n d p oi nts. S pecific reas o ns f or warra nti n g 
e xcl usi o n fr o m t his p o p ulati o n will be d oc u me nte d pri or t o 
data base l oc k.  
Safet y a nal ysis set  
All partici pa nts w h o recei ve a n y p orti o n of st u d y i nter ve nti o n . 
Partici pa nts will be a nal yze d acc or di n g t o t he i nter ve nti o n 
t he y act uall y recei ve d. 
P K a nal ysis set  
All partici pa nts w h o recei ve a n y p orti o n of st u d y  
i nter ve nti o n a n d ha ve at least o ne p ost -d ose c o nce ntrati o n 
val ue.  
 
9. 4.  St atistic al A n al yses  
T he S A P  will be de vel o pe d a n d fi nalize d bef ore a n y a nal yses are p erf or me d a n d will 
descri be t he a nal yses a n d pr oce d ures f or acc o u nti n g f or missi n g, u n use d, a n d s p uri o us data.  
T his secti o n is a s u m mar y of t he pla n ne d statistical a nal yses of t he pri mar y a n d sec o n dar y 
e n d p oi nts. 
9. 4. 1.  Ge ner al C o nsi der ati o ns  
Descri pti ve statistics will be use d i n ge neral t o s u m marize st u d y res ults  b y treat me nt gr o u ps 
K A N -1 0 1 a n d Place b o , ie, c o u nt a n d perce nt will be prese nte d f or bi nar y e n d p oi nts a n d 
cate g orical e n d p oi nts; statistics f or c o nti n u o us varia bles will i ncl u de n u m ber of o bser vati o ns, 
mea n, sta n dar d de viati o n, mi ni m u m, first, sec o n d, a n d t hir d  q uartiles, a n d ma xi m u m. T he 
C V  a n d G M  will als o be i ncl u de d, w here a p pr o priate. Gra p hics ma y be use d t o prese nt t he 
data.  
9. 4. 1. 1.  A n al yses f or C o nti n u o us  E n d p oi nts  
F or c o nti n u o us e n d p oi nts  wit h baseli ne , t he c ha n ge fr o m baseli ne will be a nal yze d b y ti me  
p oi nt usi n g  A N C O V A m o del wit h treat me nt as t he fact or, baseli ne as a c o variate. 
C o nti n u o us e n d p oi nts wit h o ut baseli ne  will be a nal yze d b y ti me  p oi nt usi n g  A N O V A m o del 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 7 1  
wit h treat me nt as a fact or. C o m paris o n of K A N -1 0 1 t o place b o  ( pr o vi di n g L S M of t he 
treat me nts, L S M of t he treat me nt differe nce, p‑ val ue a n d 9 5 % CI) will be ge nerate d.  
9. 4. 1. 2.  Missi n g D at a H a n dli n g  
N o i m p utati o n f or missi n g efficac y a n d safet y data.  
9. 4. 2.  Pri m ar y E n d p oi nt s/ Esti m a n ds A n al ysis  
9. 4. 2. 1.  Defi niti o n of E n d p oi nt s 
T he pri mar y e n d p oi nt is c ha n ge fr o m baseli ne i n t he rati o of V h: C d  as assesse d b y E G D wit h 
bi o ps y  after 2 -wee k G C  (at Da y 2 9). 
9. 4. 2. 2.  M ai n A n al ytic al A p pr o ac h  
Pri mar y e n d p oi nt  will be a nal yze d usi n g A N C O V A m o del as descri be d i n Secti o n  9. 2. 1  
base d o n Esti ma n d 1 .  
9. 4. 2. 3.  Se nsiti vit y/ S u p p orti ve  A n al ytic al A p pr o ac h  
P P a nal ysis will be perf or me d f or c ha n ge fr o m baseli ne i n t he rati o of V h: C d at Da y 2 9 visit 
usi n g A N C O V A m o del as descri be d i n Secti o n  9. 2. 1  f or P P S. If n u m ber of partici pa nts i n 
P P S is t o o s mall (e g, less t ha n 5 0 % of F A S), P P a nal ysis ma y n ot be perf or me d.  
9. 4. 3.  Sec o n d ar y E n d p oi nts  A n al ysis  
9. 4. 3. 1.  C h a n ge i n I L -2 fr o m pre G C t o p ost G C at D a y 1 5  (First D a y  of G C)  
C ha n ge i n I L -2 (l o g tra nsf or me d) will be a nal yze d usi n g A N C O V A m o del as descri be d i n 
Secti o n  9. 2. 1  base d o n Esti ma n d 2  (see Secti o n  9. 2. 1 ). P P a nal ysis will be perf or me d f or 
c ha n ge i n I L-2  (l o g tra nsf or me d) usi n g A N C O V A m o del as descri be d i n Secti o n  9. 2. 1  f or 
P P S  as well. 
9. 4. 3. 2.  C h a n ges fr o m b aseli ne i n I E L i n d u o de n u m bi o ps y at D a y 2 9 Visit  
C ha n ge i n I E L will be a nal yze d usi n g A N C O V A m o del base d o n Esti ma n d 3 (see 
Secti o n  9. 2. 1 ). P P a nal ysis will be perf or me d f or c ha n ge i n I E L usi n g A N C O V A m o del as 
descri be d i n Secti o n  9. 2. 1  f or P P S as well. 
9. 4. 3. 3.  I nci de nce a n d se verit y of T E A Es a n d I nci de nce a n d titer of K A N-1 0 1 A D A  
•  See Secti o n 9. 4. 6 . 
9. 4. 3. 4.  Pl as m a c o nce ntr ati o n of K A N -1 0 1, a n d ass oci ate d K A N -1 0 1 p ar a meters: 
A U Ci nf, A U Cl ast, C m a x, T m a x a n d t ½  
P K c o nce ntrati o n a n d P K para meters will be descri pti vel y s u m marize d b y treat me nt gr o u p.  
T he P K para meters t o be assesse d, t heir defi niti o n, a n d met h o d of deter mi nati o n are detaile d 
i n Secti o n  9. 4. 5 . Act ual P K sa m pli n g ti mes will be use d i n t he deri vati o n of P K para meters.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 7 2  
9. 4. 4.  Terti ar y/ E x pl or at or y E n d p oi nts  A n al ysis  
Res ults of t he bel o w e x pl orat or y e n d p oi nt a nal yses  will be  s u m marize d descri pti vel y, 
a nal yze d , utilize d f or i nter nal p ur p oses,  a n d ma y  n ot be descri be d i n t he C S R . T he f oll o wi n g 
e x pl orat or y e n d p oi nts will be c ollecte d:  
•  C ha n ge fr o m baseli ne i n Mars h -O ber h u ber  assesse d via E G D wit h bi o ps y  sc ore 
after t he 2-wee k G C . 
•  P R O s, i ncl u di n g C D S D v 2. 1, P GI C, a n d P GI S, will be s u m marize d t o trac k Ce D 
s y m pt o ms o ver t he d urati o n of t he st u d y.  
•  I nci de nce a n d titer of tT G I g A a n d D G P I g G  at Da y 4 2 .  
F urt her details f or e x pl orat or y a nal yses ma y  be prese nte d i n t he S A P  a n d/or a n e x pl orat or y  
S A P .  
9. 4. 5.  P h ar m ac o ki netic A n al ysis  
Act ual P K sa m pli n g ti mes will be use d i n t he deri vati o n of P K para meters. T he plas ma  
c o nce ntrati o n of K A N -1 0 1 will be liste d a n d descri pti vel y s u m marize d b y n o mi nal P K 
sa m pli n g ti me a n d treat me nt gr o u p. I n di vi d ual s u bject, mea n, a n d me dia n pr ofiles of t he 
plas ma c o nce ntrati o n-ti me data will be pl otte d b y treat me nt gr o u p usi n g act ual (f or 
i n di vi d ual) a n d n o mi nal (f or me dia n) ti mes, res pecti vel y. Mea n a n d me dia n pr ofiles will be 
prese nte d o n b ot h li near a n d l o g scales.  
T a ble 2 . 
P K P ar a meters A n al yze d  
P ar a meter  
Defi niti o n  
Met h o d of Deter mi n ati o n  
A U C last 
Area u n der t he plas ma c o nce ntrati o n -ti me 
pr ofile fr o m ti me 0 t o t he ti me of t he last 
q ua ntifia ble c o nce ntrati o n ( Clast)  
Li near/ L o g tra pez oi dal met h o d  
A U C i nf 
Area u n der t he plas ma c o nce ntrati o n -ti me 
pr ofile fr o m ti me 0 e xtra p olate d t o i nfi nite 
ti me 
A U C last + ( Clast/ K el), 
w here Clast is t he pre dicte d plas ma 
c o nce ntrati o n at t he last q ua ntifia ble ti me 
p oi nt esti mate d fr o m t he l o g -li near re gressi o n 
a nal ysis 
C ma x   
Ma xi m u m plas ma  c o nce ntrati o n  
O bser ve d directl y fr o m data  
T ma x   
Ti me t o reac h Cma x . 
O bser ve d directl y fr o m data.  
t½ a 
Ter mi nal p hase  half -life 
L o g e( 2)/ kel, w here k el is t he ter mi nal p hase 
rate c o nsta nt calc ulate d b y a li near re gressi o n 
of t he l o gli near -c o nce ntrati o n ti me - c ur ve. 
O nl y t h ose data p oi nts j u d ge d t o descri be t he 
ter mi nal l o g-li near decli ne will be use d i n t he 
re gressi o n 
a. If data per mit 
 
Please see A p pe n di x 1 1  f or a b bre viati o ns 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 7 3  
T he P K para meters i n Ta ble 2  will be s u m marize d descri pti vel y b y treat me nt gr o u p  i n 
acc or da nce wit h s p o ns or or s p o ns or ’s desi g nee  data sta n dar ds. S u m mar y statistics will als o 
i ncl u de t he ge o metric mea n a n d c oefficie nt of variati o n f or all para meters e xce pt Tma x .  
9. 4. 6.  S afet y  A n al yses  
All t he safet y data will be s u m marize d descri pti vel y t hr o u g h a p pr o priate data ta b ulati o ns, 
descri pti ve statistics, a n d / or gra p hical prese ntati o ns. All safet y a nal yses will be perf or me d o n 
t he safet y p o p ulati o n.  
9. 4. 7.  Ot her  A n al yses  
I m m u n o ge nicit y assess me nts will be s u m marize d descri pti vel y.  
P har mac o ge netics a n d b i o mar ker data fr o m Resi d ual Researc h Sa m ples  ma y be c ollecte d 
d uri n g or after t he trial a n d retai ne d f or f ut ure a nal yses; t he res ults of s uc h a nal yses are n ot 
pla n ne d t o be i ncl u de d i n t he C S R.  
9. 5.  I nteri m A n al yses  
A n I A will  be c o n d ucte d  t o assess efficac y  after a p pr o xi matel y 1 3 partici pa nts fr o m eac h 
gr o u p  ha ve c o m plete d  t hr o u g h t he Da y 2 9  visit i ncl u di n g hist ol o g y assess me nts.  .  
U nless a safet y c o ncer n arises, n o decisi o n t o st o p t he trial will be ma de base d o n t his i nteri m 
a nal ysis.  T he res ults of t he I A will be use d f or f ut ure strate gic pla n ni n g f or t he o verall K A N-
1 0 1 pr o gra m.  
Bef ore a n y i nteri m a nal ysis is perf or me d , t he details of t he o bjecti ves, decisi o n criteria, 
disse mi nati o n pla n , a n d met h o d of mai ntai ni n g t he st u d y bli n d (if a p plica ble) as per t he 
s p o ns or’s or s p o ns or desi g nee’s  S O Ps will be d oc u me nte d a n d a p pr o ve d i n a  D S M B  c harter. 
I n a d diti o n, t he a nal ysis details will be d oc u me nte d a n d a p pr o ve d i n t he S A P  or a se parate 
i nteri m statistical a nal ysis pla n . 
9. 6.  S a m ple Size Deter mi n ati o n  
A s ufficie nt n u m ber of partici pa nts will be scree ne d t o ac hie ve a p pr o xi matel y 5 2 treate d 
partici pa nts  ( 2 6 per st u d y ar m). T he sa m ple size calc ulati o n is base d o n t he pri mar y efficac y 
esti ma n d a n d its e n d p oi nt , c ha n ges fr o m baseli ne i n t he rati o of V h: C d  at Da y 2 9 visit . Wit h  
a 2-si de d t y pe I err or rate of 5 %, t he st u d y will ha ve a p pr o xi matel y 9 4 % p o wer u n der a 
sa m ple size of 2 6 partici pa nts  per ar m t o detect a treat me nt differe nce i n L S M of 0. 5 0  i n 
c ha n ge i n rati o of V h: C d  bet wee n treat me nt ar ms , ass u mi n g t hat t he c o m m o n sta n dar d 
de viati o n is 0. 5 . If 3 0 % of s u bjects dr o p o ut wit h o ut  t he pri mar y e n d p oi nt assess me nt, e ve n if 
t he dr o p o ut is u ne ve nl y distri b ute d bet wee n t he t w o gr o u ps (e g, 2 0 % dr o p o ut i n K A N -1 0 1 
gr o u p, 4 0 % i n place b o gr o u p) , t he st u d y will still have  8 2 % p o wer t o dete ct t he treat me nt 
differe nce of 0. 5 wit h e val ua ble partici pa nts (ie, f ull a nal ysis set).  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 7 4  
1 0.  S U P P O R TI N G D O C U M E N T A TI O N A N D O P E R A TI O N A L C O N SI D E R A TI O N S  
1 0. 1.  A p pe n di x 1: Re g ul at or y, Et hic al, a n d St u d y O versi g ht C o nsi der ati o ns  
1 0. 1. 1.  Re g ul at or y  a n d Et hic al C o nsi der ati o ns  
T his st u d y will be c o n d ucte d i n acc or da nce wit h t he pr ot oc ol a n d wit h t he f oll o wi n g:  
•  C o nse ns us et hical pri nci ples deri ve d fr o m i nter nati o nal g ui deli nes , i ncl u di n g t he 
Declarati o n of Helsi n ki a n d CI O M S I nter nati o nal Et hical G ui deli nes ; 
•  A p plica ble I C H G C P g ui deli nes ; 
•  A p plica ble la ws a n d re g ulati o ns , i ncl u di n g a p plica ble pri vac y la ws. 
T he pr ot oc ol, pr ot oc ol a me n d me nts, I C D , S R S D(s) , a n d ot her rele va nt d oc u me nts (e g, 
a d vertise me nts) m ust be re vie we d a n d a p pr o ve d b y t he s p o ns or, s u b mitte d t o a n I R B/ E C b y 
t he i n vesti gat or, a n d re vie we d a n d a p pr o ve d b y t he I R B/ E C bef ore t he st u d y is i nitiate d.  
A n y a me n d me nts t o t he pr ot oc ol will re q uire I R B/ E C a p pr o val bef ore i m ple me ntati o n of 
c ha n ges ma de t o t he st u d y desi g n, e xce pt f or c ha n ges necessar y t o eli mi nate a n i m me diate 
hazar d t o st u d y partici pa nts.  
Pr ot oc ols a n d a n y s u bsta ntial a me n d me nts t o t he pr ot oc ol will re q uire healt h a ut h orit y 
a p pr o val pri or t o i nitiati o n e xce pt f or c ha n ges necessar y t o eli mi nate a n i m me diate hazar d t o 
st u d y partici pa nts. 
I n a d diti o n t o t he safet y re p orti n g res p o nsi bilities t o t he S p o ns or i n Secti o n 1 0. 3. 4, a n d i n 
acc or da nce wit h l ocal re g ulati o ns, t he i n vesti gat or ma y  be res p o nsi ble f or t he f oll o wi n g:  
•  Pr o vi di n g writte n s u m maries of t he stat us of t he st u d y t o t he I R B/ E C a n n uall y or 
m ore fre q ue ntl y i n acc or da nce wit h t he l ocal re g ulat or y re q uire me nts, p olicies, a n d 
pr oce d ures esta blis he d b y t he I R B/ E C ; 
•  N otif yi n g t he I R B/ E C of S A Es or ot her si g nifica nt safet y fi n di n gs as re q uire d b y 
I R B/ E C pr oce d ures; 
•  Pr o vi di n g o versi g ht of t he c o n d uct of t he st u d y at t he site a n d a d here nce t o 
re q uire me nts of 2 1 C F R, I C H G C P g ui deli nes, t he I R B/ E C, E ur o pea n re g ulati o n 
5 3 6/ 2 0 1 4 f or cli nical st u dies, a n d all ot her a p plica ble l ocal re g ulati o ns . 
1 0. 1. 1. 1.  Re p orti n g of S afet y Iss ues a n d Seri o us Bre a c hes of t he Pr ot oc ol or I C H G C P  
I n t he e ve nt of a n y pr o hi biti o n or restricti o n i m p ose d (ie, cli nical h ol d) b y a n a p plica ble 
re g ulat or y a ut h orit y i n a n y area of t he w orl d, or if t he i n vesti gat or is a ware of a n y ne w 
i nf or mati o n t hat mi g ht i nfl ue nce t he e val uati o n of t he be nefits a n d ris ks of t he st u d y 
i nter ve nti o n, Pfizer  s h o ul d be i nf or me d i m me diatel y.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 7 5  
I n a d diti o n, t he i n vesti gat or will i nf or m Pfizer  im me diatel y of a n y ur ge nt safet y meas ures 
ta ke n b y t he i n vesti gat or t o pr otect t he st u d y partici pa nt s a gai nst a n y i m me diate hazar d, a n d 
of a n y seri o us breac hes of t his pr ot oc ol or of t he I C H G C P g ui deli nes  t hat t he i n vesti gat or 
bec o mes a ware of.  
1 0. 1. 2.  Fi n a nci al Discl os ure  
I n vesti gat ors a n d s u bi n vesti gat ors will pr o vi de t he s p o ns or or s p o ns or ’s desi g nee wit h 
s ufficie nt, acc urate fi na ncial i nf or mati o n as re q ueste d t o all o w t he s p o ns or or s p o ns or ’s 
desi g nee t o s u b mit c o m plete a n d acc urate fi na ncial certificati o n or discl os ure state me nts t o 
t he a p pr o priate re g ulat or y a ut h orities. I n vesti gat ors are res p o nsi ble f or pr o vi di n g i nf or mati o n 
o n fi na ncial i nterests d uri n g t he c o urse of t he st u d y a n d f or 1 year after c o m pleti o n of t he 
st u d y. 
1 0. 1. 3.  I nf or me d C o nse nt Pr ocess  
T he i n vesti gat or or t he i n vesti gat or’s re prese ntati ve will e x plai n t he nat ure of t he st u d y, 
i ncl u di n g t he ris ks a n d be nefits, t o t he partici pa nt or t heir le gall y a ut h orize d re prese ntati ve 
a n d a ns wer all q uesti o ns re gar di n g t he st u d y.  T he partici pa nt or t heir le gall y a ut h orize d 
re prese ntati ve s h o ul d be gi ve n s ufficie nt ti me a n d o p p ort u nit y t o as k q uesti o ns a n d t o deci de 
w het her or n ot t o partici pate i n t he trial.  
Partici pa nts m ust be i nf or me d t hat t heir partici pati o n is v ol u ntar y. Partici pa nts or t heir le gall y 
a ut h orize d re prese ntati ve  (if all o we d b y l ocal re g ulati o ns) will be re q uire d t o si g n a state me nt 
of i nf or me d c o nse nt t hat meets t he re q uire me nts of 2 1 C F R 5 0, l ocal re g ulati o ns, I C H 
g ui deli nes, pri vac y,  a n d data pr otecti o n  re q uire me nts, w here a p plica ble, a n d t he I R B/ E C or 
st u d y ce nter. 
T he i n vesti gat or m ust e ns ure t hat eac h partici pa nt  or t heir le gall y a ut h orize d re prese ntati ve is 
f ull y i nf or me d a b o ut t he nat ure a n d o bjecti ves of t he st u d y, t he s hari n g of data relate d t o t he 
st u d y, a n d p ossi ble ris ks ass ociate d wit h partici pati o n, i ncl u di n g t he ris ks ass ociate d wit h t he 
pr ocessi n g of t he partici pa nt ’s pers o nal data.  
T he partici pa nt  or t heir le gall y a ut h orize d re prese ntati ve m ust be i nf or me d t hat t heir pers o nal 
st u d y-relate d data will be use d b y t he s p o ns or or s p o ns or ’s desi g nee  i n acc or da nce wit h l ocal 
data pr otecti o n la w. T he le vel of discl os ure m ust als o be e x plai ne d t o t he partici pa nt  or t heir 
le gall y a ut h orize d re prese ntati ve. 
T he partici pa nt  or t heir le gall y a ut h orize d re prese ntati ve m ust be i nf or me d t hat t heir me dical 
rec or ds ma y be e xa mi ne d b y Cli nical Q ualit y Ass ura nce a u dit ors or ot her a ut h orize d 
pers o n nel a p p oi nte d b y t he s p o ns or, b y a p pr o priate I R B/ E C me m bers, a n d b y i ns pect ors 
fr o m re g ulat or y a ut h orities. 
T he i n vesti gat or f urt her m ust e ns ure t hat eac h st u d y partici pa nt  or t heir le gall y a ut h orize d 
re prese ntati ve is f ull y i nf or me d a b o ut t heir ri g ht t o access a n d c orrect t heir pers o nal data a n d 
t o wit h dra w c o nse nt f or t he pr ocessi n g of t heir pers o nal data.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 7 6  
T he me dical rec or d m ust i ncl u de a state me nt t hat writte n i nf or me d c o nse nt was o btai ne d 
bef ore t he partici pa nt was e nr olle d i n t he st u d y a n d t he date o n w hic h  t he writte n c o nse nt was 
o btai ne d. T he a ut h orize d pers o n o btai ni n g t he i nf or me d c o nse nt m ust als o si g n t he I C D . 
Partici pa nts  or t heir le gall y a ut h orize d re prese ntati ve m ust be rec o nse nte d t o t he m ost c urre nt 
versi o n of t he I R B/ E C-a p pr o ve d I CD (s) d uri n g t heir partici pati o n i n t he st u d y as re q uire d per 
l ocal re g ulati o ns. 
A c o p y of t he I C D (s) m ust be pr o vi de d t o t he partici pa nt or t heir le gall y a ut h orize d 
re prese ntati ve (if all o we d b y l ocal re g ulati o ns). 
Partici pa nts w h o are rescree ne d are re q uire d t o si g n a ne w I C D . 
1 0. 1. 4.  D at a Pr otecti o n  
All parties will c o m pl y wit h all a p plica ble la ws, i ncl u di n g la ws re gar di n g t he i m ple me ntati o n 
of or ga nizati o nal a n d tec h nical meas ures t o e ns ure pr otecti o n of partici pa nt  data.  
Partici pa nts’ pers o nal data will be st ore d at t he st u d y site i n  e ncr y pte d electr o nic a n d/ or pa per 
f or m a n d will be pass w or d  pr otecte d or sec ure d i n a l oc ke d r o o m t o e ns ure t hat o nl y 
a ut h orize d st u d y staff ha ve access. T he st u d y site will i m ple me nt a p pr o priate tec h nical a n d 
or ga nizati o nal meas ures t o e ns ure t hat t he pers o nal data ca n be rec o vere d i n t he e ve nt of 
disaster. I n t he e ve nt of a p ote ntial pers o nal data br eac h, t he st u d y site will be res p o nsi ble f or 
deter mi ni n g w het her a pers o nal data breac h has i n  fact occ urre d a n d, if s o, pr o vi di n g breac h 
n otificati o ns as re q uire d b y la w.  
To pr otect t he ri g hts a n d free d o ms of partici pa nts  wit h re gar d t o t he pr ocessi n g of pers o nal 
data, partici pa nts will be assi g ne d a si n gle, partici pa nt -s pecific n u merical c o de. A n y 
partici pa nt rec or ds or data  sets t hat are tra nsferre d t o t he s p o ns or or s p o ns or ’s desi g nee will 
c o ntai n t he n u merical c o de; partici pa nt na mes will n ot be tra nsferre d. All ot her i de ntifia ble 
data tra nsferre d t o t he s p o ns or or s p o ns or ’s desi g nee  will be i de ntifie d b y t his si n gle, 
partici pa nt -s pecific c o de. T he st u d y site will mai ntai n a c o nfi de ntial list of partici pa nt s w h o 
partici pate d i n t he st u d y, li n ki n g eac h partici pa nt ’s n u merical c o de t o t heir act ual i de ntit y  a n d 
me dical rec or d I D. I n case of data tra nsfer, t he s p o ns or or s p o ns or ’s desi g nee  will pr otect t he 
c o nfi de ntialit y of partici pa nt s’ pers o nal data c o nsiste nt wit h t he cli nical st u d y agree me nt a n d 
a p plica ble pri vac y la ws.  
I nf or mati o n tec h n ol o g y s yste ms use d t o c ollect, pr ocess, a n d st ore st u d y-relate d data are 
sec ure d b y tec h nical a n d or ga nizati o nal sec urit y meas ures desi g ne d t o pr otect s uc h data 
a gai nst acci de ntal or u nla wf ul l oss, alterati o n, or u na ut h orize d discl os ure or  access. 
T he s p o ns or  or s p o ns or ’s desi g nee  mai ntai ns S O P s o n h o w t o res p o n d i n t he e ve nt of 
u na ut h orize d access, use, or discl os ure of s p o ns or  or s p o ns or ’s desi g nee  i nf or mati o n or 
s yste ms. 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 7 7  
1 0. 1. 5.  C o m mittees Str uct ure  
1 0. 1. 5. 1.  D at a M o nit ori n g C o m mittee  
T his st u d y will use  a D S M B. T he D S M B  is i n de pe n de nt of t he st u d y tea m a n d i ncl u des o nl y 
e xter nal  (at least 2 p h ysicia ns, o ne of w hic h will be a Ce D me dical e x pert, a n d 1 
bi ostatisticia n  i n de pe n de nt fr o m t he c o n d uct of t he st u d y) me m bers. T he D S M B  c harter 
descri bes t he r ole of t he D S M B  i n m ore detail. T he D S M B safet y m o nit ori n g pla n will be 
detaile d i n t he D S M B c harter.  
T he pri mar y res p o nsi bilit y of t he D S M B is t o safe g uar d st u d y partici pa nts b y re vie wi n g a n d 
assessi n g t he c u m ulati ve cli nical safet y data bei n g c ollecte d d uri n g t he perf or ma nce of t he 
st u d y. T he D S M B will meet peri o dicall y t hr o u g h o ut t he st u d y t o re vie w c u mulati ve safet y 
data.  T he D S M B  will be res p o nsi ble f or o n g oi n g m o nit ori n g of t he safet y of partici pa nts i n 
t he st u d y acc or di n g t o t he c harter. T he rec o m me n dati o ns ma de b y t he D S M B will be 
f or war de d t o t he a p pr o priate a ut h orize d s p o ns or pers o n nel f or re vie w a n d fi nal decisi o n. T he 
s p o ns or or s p o ns or ’s desi g nee  will c o m m u nicate s uc h decisi o ns, w hic h ma y i ncl u de 
s u m maries of a g gre gate a nal yses of safet y data, t o re g ulat or y a ut h orities a n d i n vesti gat ors, as 
a p pr o priate.  
1 0. 1. 6.  Disse mi n ati o n of Cli nic al St u d y D at a  
T he s p o ns or  f ulfills its c o m mit me nt t o p u blicl y discl ose cli nical st u d y res ults t hr o u g h p osti n g 
t he res ults of st u dies o n w w w.cli nicaltrials. g o v ( Cli nical Trials. g o v), t he E u dra C T/ C TI S, a n d 
ot her p u blic re gistries a n d we bsites i n acc or da nce wit h a p plica ble l ocal la ws/re g ulati o ns. I n 
a d diti o n, t he s p o ns or re p orts st u d y res ults o utsi de of t he re q uire me nts of l ocal 
la ws/re g ulati o ns p urs ua nt t o its S O Ps. 
I n all cases, st u d y res ults are re p orte d b y t he s p o ns or i n a n o bjecti ve, acc urate, bala nce d, a n d 
c o m plete ma n ner a n d are re p orte d re gar dless of t he o utc o me of t he st u d y or t he c o u ntr y i n 
w hic h t he st u d y was c o n d ucte d.  
w w w.cli nicaltrials. g o v  
T he s p o ns or  p osts cli nical trial res ults o n w w w.cli nicaltrials. g o v f or Ka n y os  Bi o, 
I nc.-s p o ns ore d i nter ve nti o nal st u dies (c o n d ucte d i n patie nts) t hat e val uate t he safet y a n d/ or 
efficac y of a pr o d uct, re gar dless of t he ge o gra p hical l ocati o n i n w hic h t he st u d y is c o n d ucte d. 
T hese r es ults are s u b mitte d f or p osti n g i n acc or da nce wit h t he f or mat a n d ti meli nes set f ort h 
b y U S la w.  
E u dra C T / C TI S 
T he s p o ns or  p osts cli nical trial r es ults o n E u dra C T / C TI S f or Ka n y os  Bi o, I nc. -s p o ns ore d 
i nter ve nti o nal st u dies i n acc or da nce wit h t he f or mat a n d ti meli nes set f ort h b y E U 
re q uire me nts. 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 7 8  
D oc u me nts wit hi n mar keti n g a p plicati o ns 
T he s p o ns or  c o m plies wit h a p plica ble l ocal la ws/re g ulati o ns t o p u blis h cli nical d oc u me nts 
i ncl u de d i n mar keti n g a p plicati o ns. Cli nical d oc u me nts i ncl u de s u m mar y d oc u me nts a n d 
C S Rs i ncl u di n g t he pr ot oc ol a n d pr ot oc ol a me n d me nts, sa m ple C R Fs, a n d S A P s. Cli nical 
d oc u me nts will ha ve pers o nall y i de ntifia ble i nf or mati o n a n o n y mize d.  
Data shari n g  
T he s p o ns or  pr o vi des researc hers sec ure access t o partici pa nt -le vel data or f ull C S Rs f or t he 
p ur p oses of “ b o na -fi de scie ntific researc h” t hat c o ntri b utes t o t he scie ntific u n dersta n di n g of 
t he disease, tar get, or c o m p o u n d class. T he s p o ns or  will ma ke data fr o m t hese trials a vaila ble 
1 8  m o nt hs after st u d y c o m pleti o n. Partici pa nt -le vel data will be a n o n y mize d i n acc or da nce 
wit h a p plica ble pri vac y la ws a n d re g ulati o ns.  C S Rs will ha ve pers o nall y i de ntifia ble 
i nf or mati o n a n o n y mize d. 
Data re q uests are c o nsi dere d fr o m q ualifie d researc hers wit h t he a p pr o priate c o m pete ncies t o 
perf or m t he pr o p ose d a nal yses.  Researc h tea ms m ust i ncl u de a bi ostatisticia n. Data will n ot 
be pr o vi de d t o a p plica nts wit h si g nifica nt c o nflicts of i nterest, i ncl u di n g i n di vi d uals 
re q uesti n g access f or c o m mercial/c o m petiti ve or le gal p ur p oses. 
1 0. 1. 7.  D at a Q u alit y Ass ur a nce  
All partici pa nt data relati n g t o t he st u d y will be rec or de d o n pri nte d or electr o nic C R F u nless 
tra ns mitte d t o t he s p o ns or or desi g nee electr o nicall y (e g, la b orat or y data). T he i n vesti gat or is 
res p o nsi ble f or verif yi n g t hat data e ntries are acc urate a n d c orrect b y p h ysicall y or 
electr o nicall y si g ni n g t he C R F.  
G ui da nce o n c o m pleti o n of C R Fs will be pr o vi de d i n t he C R F C o m pleti o n Re q uire me nts 
d oc u me nt . 
T he i n vesti gat or m ust e ns ure t hat t he C R Fs are sec urel y st ore d at t he st u d y site i n  e ncr y pte d 
electr o nic a n d/ or pa per  f or m a n d are pass w or d pr otecte d or sec ure d i n a l oc ke d r o o m  t o 
pre ve nt access b y u na ut h orize d t hir d parties.  
T he i n vesti gat or m ust per mit st u d y -relate d m o nit ori n g, a u dits, I R B/ E C re vie w, a n d 
re g ulat or y a ge nc y i ns pecti o ns a n d pr o vi de direct access t o s o urce rec or ds a n d d oc u me nts.  
T his verificati o n ma y als o occ ur after st u d y c o m pleti o n. It is i m p orta nt t hat t he 
i n vesti gat or(s) a n d t heir rele va nt pers o n nel are a vaila ble d uri n g t he m o nit ori n g visits a n d 
p ossi ble a u dits or i ns pecti o ns a n d t hat s ufficie nt ti me is de v ote d t o t he pr ocess . 
M o nit ori n g details descri bi n g strate g y , i ncl u di n g defi niti o n of st u d y-critical data ite ms a n d 
pr ocesses  (e g, ris k-base d i nitiati ves i n o perati o ns a n d q ualit y s uc h as ris k m a na ge me nt a n d 
m iti gati o n strate gies a n d anal ytical ris k-b ase d m o nit ori n g), met h o ds, res p o nsi bilities , a n d 
re q uire me nts, i ncl u di n g ha n dli n g of n o nc o m plia nce iss ues a n d m o nit ori n g tec h ni q ues 
(ce ntral, virt ual , or o n-site m o nit ori n g), are pr o vi de d i n t he  data ma na ge me nt pla n  a n d 
m o nit ori n g p la n mai ntai ne d a n d utilize d b y t he s p o ns or or desi g nee .  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 7 9  
T he s p o ns or or desi g nee is res p o nsi ble f or t he data ma na ge me nt of t his st u d y , i ncl u di n g 
q ualit y c hec ki n g of t he data.  
Rec or ds a n d d oc u me nts, i ncl u di n g si g ne d I C D s, pertai ni n g t o t he c o n d uct of t his st u d y m ust 
be retai ne d b y t he i n vesti gat or f or 1 5  years after st u d y c o m pleti o n u nless  l ocal re g ulati o ns or 
i nstit uti o nal p olicies re q uire a l o n ger rete nti o n peri o d. N o rec or ds ma y be destr o ye d d uri n g 
t he rete nti o n peri o d wit h o ut t he writte n a p pr o val of t he s p o ns or. N o rec or ds ma y be 
tra nsferre d t o a n ot her l ocati o n or part y wit h o ut writte n n otificati o n t o t he s p o ns or.  T he 
i n vesti gat or m ust e ns ure t hat t he rec or ds c o nti n ue t o be st ore d sec urel y f or as l o n g as t he y are 
mai ntai ne d.  
W he n partici pa nt  data are t o be delete d, t he i n vesti gat or will e ns ure t hat all c o pies of s uc h 
data are pr o m ptl y a n d irre v oca bl y delete d fr o m all s yste ms.  
T he i n vesti gat or(s) will n otif y  t he s p o ns or or its a ge nts i m me diatel y of a n y re g ulat or y 
i ns pecti o n n otificati o n i n relati o n t o t he st u d y. F urt her m ore, t he i n vesti gat or will c o o perate 
wit h t he s p o ns or or its a ge nts t o pre pare t he i n vesti gat or site f or t he i ns pecti o n a n d will all o w 
t he s p o ns or or its a ge nt, w he ne ver feasi ble, t o be prese nt d uri n g t he i ns pecti o n. T he 
i n vesti gat or site a n d i n vesti gat or will pr o m ptl y res ol ve a n y discre pa ncies t hat are i de ntifie d 
bet wee n t he st u d y data a n d t he partici pa nt ’s me dical rec or ds. T he i n vesti gat or will pr o m ptl y 
pr o vi de c o pies of t he i ns pecti o n fi n di n gs t o t he s p o ns or or its a ge nt. Bef ore res p o nse 
s u b missi o n t o t he re g ulat or y a ut h orities, t he i n vesti gat or will pr o vi de t he s p o ns or or its 
a ge nts wit h a n o p p ort u nit y t o re vie w a n d c o m me nt o n res p o nses t o a n y s uc h fi n di n gs.  
1 0. 1. 8.  S o urce D oc u me nts  
S o urce d oc u me nts pr o vi de e vi de nce f or t he e xiste nce of t he partici pa nt a n d s u bsta ntiate t he 
i nte grit y of t he data c ollecte d. S o urce d oc u me nts are file d at t he i n vesti gat or site. 
Data re p orte d o n t he C R F or e ntere d i n t he e C R F t hat are fr o m s o urce d oc u me nts m ust be 
c o nsiste nt wit h t he s o urce d oc u me nts or t he discre pa ncies m ust be e x plai ne d . T he 
i n vesti gat or ma y nee d t o re q uest pre vi o us me dical rec or ds or tra nsfer rec or ds, de pe n di n g o n 
t he st u d y. Als o, c urre nt me dical rec or ds m ust be a vaila ble. 
I n t his st u d y, t he C R F will ser ve as t he s o urce d oc u me nt. A d oc u me nt m ust be a vaila ble at 
t he i n vesti gati ve site t hat i de ntifies t h ose data t hat will be rec or de d o n t he C R F a n d f or w hic h 
t he C R F will be t he s o urce d oc u me nt.  
Defi niti o n of w hat c o nstit utes s o urce d oc u me nt a n d its ori gi n ca n be f o u n d i n  t he S o urce 
D oc u me nt L ocat or , w hic h is mai ntai ne d b y t he s p o ns or or  s p o ns or’s desi g nee ( Pfizer). 
Descri pti o n of  t he use of t he c o m p uterize d s yste m is d oc u me nte d i n  t he d ata m a na ge me nt 
p la n, w hic h is mai ntai ne d b y t he s p o ns or or s p o ns or’s desi g nee .  
T he i n vesti gat or m ust mai ntai n acc urate d oc u me ntati o n (s o urce rec or d) t hat s u p p orts t he 
i nf or mati o n e ntere d i n t he C R F. 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 8 0  
T he s p o ns or or desi g nee  will perf or m m o nit ori n g  t o c o nfir m t hat data e ntere d i nt o t he C R F 
b y a ut h orize d site pers o n nel are acc urate, c o m plete, a n d verifia ble fr o m s o urce d oc u me nts; 
t hat t he safet y a n d ri g hts of partici pa nts are bei n g pr otecte d; a n d t hat t he st u d y is bei n g 
c o n d ucte d i n acc or da nce wit h t he c urre ntl y a p pr o ve d pr ot oc ol a n d a n y ot her st u d y 
a gree me nts, I C H G C P g ui deli nes , a n d all a p plica ble re g ulat or y re q uire me nts.  
1 0. 1. 9.  Use of Me dic al Rec or ds  
T here ma y be i nsta nces w he n c o pies of me dical rec or ds f or certai n cases are re q ueste d b y t he 
s p o ns or or s p o ns or desi g nee, w here et hicall y a n d scie ntificall y j ustifie d a n d per mitte d b y 
l ocal re g ulati o ns, t o e ns ure partici pa nt safet y. 
D ue t o t he p ote ntial f or a partici pa nt t o be re -i de ntifie d fr o m t heir me dical rec or ds, t he 
f oll o wi n g acti o ns m ust be ta ke n w he n me dical rec or ds are se nt t o t he s p o ns or or s p o ns or 
desi g nee:  
 
•  T he i n vesti gat or or site staff m ust re dact pers o nal i nf or mati o n fr o m t he me dical 
rec or d. T he pers o nal i nf or mati o n i ncl u des, b ut is n ot li mite d t o, t he f oll o wi n g: 
partici pa nt na mes or i nitials , partici pa nt dates  (e g, birt h date, date of h os pital 
a d missi o n/ disc har ge, date of deat h), partici pa nt i de ntificati o n n u m bers (e g, S ocial 
Sec urit y n u m ber, healt h i ns ura nce n u m ber, me dical rec or d n u m ber, 
h os pital/i nstit uti o n i de ntifier), p artici pa nt l ocati o n i nf or mati o n (e g, street a d dress, 
cit y, c o u ntr y, p ostal c o de, I P a d dress), partici pa nt c o ntact i nf or mati o n  (e g, 
tele p h o ne/fa x n u m ber, e mail a d dress). 
•  Eac h me dical rec or d m ust be tra ns mitte d t o t he s p o ns or or s p o ns or desi g nee usi n g 
s yste ms wit h tec h nical a n d or ga nizati o nal sec urit y meas ures t o e ns ure t he pr otecti o n 
of pers o nal data (e g, Fl ore nce is t he preferre d s yste m if a vaila ble).  
•  T here ma y be u n pla n ne d sit uati o ns w here t he s p o ns or ma y re q uest me dical rec or ds 
(e g, s hari n g me dical rec or ds s o t hat t he s p o ns or ca n pr o vi de st u d y-relate d a d vice t o 
t he i n vesti gat or). T he me dical rec or ds s h o ul d be s u b mitte d acc or di n g t o t he pr oce d ure 
descr i be d a b o ve.  
1 0. 1. 1 0.  St u d y a n d Site St art a n d Cl os ure  
T he st u d y start date is t he date of t he first partici pa nt’s first visit . 
T he s p o ns or reser ves t he ri g ht t o cl ose t he st u d y site or ter mi nate t he st u d y at a n y ti me f or 
a n y reas o n at t he s ole discreti o n of t he s p o ns or, i ncl u di n g ( b ut n ot li mite d t o) re g ulat or y 
a ut h orit y decisi o n, c ha n ge i n o pi ni o n of t he I R B/ E C, or c ha n ge i n be nefit -ris k assess me nt. 
St u d y sites will be cl ose d u p o n st u d y c o m pleti o n. A st u d y site is c o nsi dere d cl ose d w he n all 
re q uire d d oc u me nts a n d st u d y s u p plies ha ve bee n c ollecte d a n d a st u d y-site cl os ure visit has 
bee n perf or me d.  
T he i n vesti gat or ma y i nitiate st u d y -site cl os ure at a n y ti me u p o n n otificati o n t o t he s p o ns or 
or desi g nee  ( Pfizer) if re q ueste d t o d o s o b y t he res p o nsi ble I R B/ E C or if s uc h ter mi nati o n is 
re q uire d t o pr otect t he healt h of st u d y partici pa nts. 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 8 1  
Reas o ns f or t he earl y cl os ure of a st u d y site b y t he s p o ns or ma y i ncl u de b ut are n ot li mite d 
t o: 
•  Fail ure of t he i n vesti gat or t o c o m pl y wit h t he pr ot oc ol, t he re q uire me nts of t he 
I R B/ E C or l ocal healt h a ut h orities, t he s p o ns or’s pr oce d ures, or t he I C H G C P 
g ui deli nes ; 
•  I na de q uate recr uit me nt of partici pa nts b y t he i n vesti gat or;  
•  Disc o nti n uati o n of f urt her st u d y i nter ve nti o n de vel o p me nt . 
If t he st u d y is pre mat urel y ter mi nate d or s us pe n de d, t he s p o ns or or desi g nee s hall pr o m ptl y 
i nf or m t he in vesti gat ors, t he E C s/I R Bs, t he re g ulat or y a ut h orities, a n d a n y C R O (s) use d i n 
t he st u d y of t he reas o n f or ter mi nati o n or s us pe nsi o n, as s pecifie d b y t he a p plica ble 
re g ulat or y re q uire me nts. T he in vesti gat or s hall pr o m ptl y i nf or m t he partici pa nt  a n d s h o ul d 
ass ure a p pr o priate partici pa nt  t hera p y a n d/ or f oll o w-u p.  
St u d y ter mi nati o n is als o pr o vi de d f or i n t he cli nical st u d y a gree me nt. If t here is a n y c o nflict 
bet wee n t he c o ntract a n d t his pr ot oc ol , t he c o ntract will c o ntr ol as t o ter mi nati o n ri g hts. 
1 0. 1. 1 1.  P u blic ati o n P olic y  
P u blicati o n b y t he cli nical st u d y site(s) of a n y data fr o m t his st u d y m ust be carrie d o ut i n 
acc or da nce wit h t he Cli nical Site A gree me nt , see 1 0. 1. 6 f or details relate d t o st u d y res ults 
relate d t o p u blicati o n.  
1 0. 1. 1 2.  S p o ns or’s Me dic all y Q u alifie d I n di vi d u al  
T he s p o ns or will desi g nate a me dicall y q ualifie d i n di vi d ual ( M QI, als o k n o w n as t he me dical 
m o nit or) t o a d vise t he i n vesti gat or o n st u d y -relate d me dical q uesti o ns. T he c o ntact 
i nf or mati o n f or t he st u d y me dical m o nit or is d oc u me nte d i n t he St u d y Tea m C o ntact List 
l ocate d i n t he I n vesti gat or Site File.  Partici pa nts are pr o vi de d wit h a Pfizer st u d y 
i nf or mati o n car d at t he ti me of i nf or me d c o nse nt, w hic h i ncl u des c o ntact i nf or mati o n f or 
t heir i n vesti gat or i n case of st u d y-relate d me dical q uesti o ns. T he st u d y inf or mati o n car d 
c o ntai ns, at a mi ni m u m, (a) st u d y n u m ber, ( b) partici pa nt’s st u d y i de ntificati o n n u m ber, a n d 
(c) pri nci pal i n vesti gat or c o ntact i nf or mati o n.  
 
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 8 2  
1 0. 2.  A p pe n di x 2: Cli nic al L a b or at or y Tests  
T he f oll o wi n g la b orat or y tests will be perf or me d at ti mes defi ne d i n t he S o A  secti o n of t his 
pr ot oc ol. A d diti o nal la b orat or y res ults ma y  be re p orte d o n t hese sa m ples as a res ult of t he 
met h o d of a nal ysis or t he t y pe of a nal yzer use d b y t he cli nical la b orat or y , or as deri ve d fr o m 
calc ulate d val ues. T hese a d diti o nal tests w o ul d n ot re q uire a d diti o nal c ollecti o n of bl o o d. 
U nsc he d ule d cli nical la b orat or y meas ure me nts ma y be o btai ne d at a n y ti me d uri n g t he st u d y 
t o assess a n y percei ve d safet y iss ues. 
Cli nical la b orat or y tests s h o ul d be perf or me d pri or t o K A N -1 0 1/ place b o i nf usi o n w he n 
a p plica ble.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 8 3  
T a ble 3 . 
Pr ot oc ol -Re q uire d L a b or at or y Assess me nts  
He m at ol o g y  
C he mistr y  
Uri n al ysis  
Ot her  
He m o gl o bi n  
He mat ocrit  
R B C c o u nt  
Platelet c o u nt  
W B C c o u nt 
T otal ne utr o p hils ( A bs , 
% ) 
E osi n o p hils ( A bs , %) 
M o n oc ytes ( A bs , %) 
Bas o p hils ( A bs , %) 
L y m p h oc ytes ( A bs , %) 
P T  
a P T T 
I N R 
Urea  a n d creati ni ne 
Ser u m c ystati n C  
e G F R 
Gl uc ose (fasti n g)  
Ca lci u m 
S o di u m  
P otassi u m  
C hl ori de  
T otal C O 2 (b icar b o nate) 
A S T, A L T  
T otal  a n d direct b ilir u bi n 
Al kali ne p h os p hatase  
Uric aci d  
Al b u mi n  
T otal pr otei n  
Ma g nesi u m  
A m ylase  
Li pase  
P h os p h or us  
L ocal d i pstic k: 
p H  
Gl uc ose ( q ual)  
Pr otei n ( q ual)  
Bl o o d ( q ual)  
Ket o nes  
Nitrites  
Le u k oc yte esterase  
 
La b orat or y:  
Micr osc o p y a n d cult ure a 
At scree n i n g: 
 
F S H b 
 
Pre g na nc y test 
( β-h C G) c  
 
H B s A g a n d HB c A b. 
H B s A b a n d H B V 
D N A as refle x tests 
 
He patitis C a nti b o d y  
a n d H C V R N A as 
refle x test 
 
HI V  
 
H L A ge n ot y pe a n d 
Ce D ser ol o g y (e g, 
H L A -D Q 2. 5 a n d 
H L A -D Q 8 testi n g d,  
 
t T G a n d D G P 
I g A/I g G) 
 
Bi o mar ker:  I L-2  
 
P K/ A D A  
 
A L T:  ala ni ne a mi n otra nsferase , A S T:  as partate a mi n otra nsferase , B -h C G:  -h u ma n c h ori o nic 
g o na d otr o pi n , esti mate d gl o mer ular filtrati o n rate , D G P: dea mi date d glia di n pe pti de(s) ,D N A:  
de o x yri b o n ucleic aci d , F S H:  f ollicle-sti m ulati n g h or m o ne, D G P:  dea mi date d glia di n pe pti de(s) , 
H B V: He patitis B vir us, H C V: He patitis C vir us,  H Bs A b: He patitis s urface a nti b o d y, H Bc A b:  he patitis B 
c ore a nti b o d y , H Bs A g: he patitis B s urface a nti ge n , HI V; h u ma n i m m u n o deficie nc y vir us , H L A:  h u ma n 
le u k oc yte a nti ge n, I g A/I g G: i m m u n o gl o b uli n A, i m m u n o gl o b uli n G, a n d I g A/I g G: i m m u n o gl o b uli n A, 
i m m u n o gl o b uli n G 
Please als o see A p pe n di x D f or a b bre viati o ns  
 
a. 
O nl y if Uri nar y Tract I nfecti o n  is s us pecte d a n d uri ne di pstic k is p ositi ve f or nitrites or le u k oc yte 
esterase or b ot h.  
b.  F or c o nfir mati o n of p ost me n o pa usal stat us o nl y . 
c. 
A ser u m pre g na nc y test is re q uire d at  scree ni n g. F oll o wi n g scree ni n g, local uri ne testi n g will be sta n dar d 
f or t he pr ot oc ol u nless ser u m testi n g is re q uire d b y l ocal re g ulati o n or I R B/ E C. Ser u m or uri ne -h C G 
f or fe male partici pa nts of c hil d beari n g p ote ntial. 
d.  F or re -scree ni n g, t he H L A d oes n ot nee d t o be re peate d a n d Ce D ser ol o g y ( t he t T G a n d D G P a nti b o d y 
tests) s h o ul d o nl y be re peate d if > 3 m o nt hs ha ve ela pse d fr o m pre vi o us  assess me nt.  
 
T he i n vesti gat or m ust re vie w t he la b orat or y re p ort, d oc u me nt t his re vie w, a n d rec or d a n y 
cli nicall y rele va nt c ha n ges occ urri n g d uri n g t he st u d y i n t he A E secti o n of t he C R F.  
La b orat or y/a nal yte res ults t hat c o ul d u n bli n d t he st u d y a n d ha ve bee n c ollecte d f or t he 
p ur p ose of t he st u d y will n ot be re p orte d t o i n vesti gat or  sites or ot her bli n de d pers o n nel u ntil 
t he st u d y has bee n u n bli n de d. 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 8 4  
1 0. 3.  A p pe n di x 3: A d verse E ve nts: Defi niti o ns a n d Pr oce d ures f or Rec or di n g, 
E v al u ati n g, F oll o w -U p, a n d Re p orti n g  
1 0. 3. 1.  Defi niti o n of A E  
A E Defi niti o n  
•  A n A E is a n y u nt o war d me dical occ urre nce i n a patie nt or cli nical st u d y 
partici pa nt, te m p orall y ass ociate d wit h t he use of st u d y i nter ve nti o n, w het her or n ot 
c o nsi dere d relate d t o t he st u d y i nter ve nti o n.  
•  N ote : A n A E ca n t heref ore be a n y u nfa v ora ble a n d u ni nte n de d si g n (i ncl u di n g a n 
a b n or mal la b orat or y fi n di n g), s y m pt o m, or disease ( ne w or e xacer bate d) 
te m p orall y ass ociate d wit h t he use of st u d y i nter ve nti o n. 
 
E ve nts Meeti n g  t he A E Defi niti o n 
•  A n y a b n or mal la b orat or y test res ults ( he mat ol o g y, cli nical c he mistr y, or uri nal ysis) 
or ot her safet y assess me nts ( eg , E C G, ra di ol o gical sca ns, vital si g n meas ure me nts), 
i ncl u di n g t h ose t hat w orse n fr o m baseli ne, c o nsi dere d cli nicall y si g nifica nt i n t he 
me dical a n d scie ntific j u d g me nt of t he i n vesti gat or . A n y a b n or mal la b orat or y test 
res ults t hat meet a n y of t he c o n diti o ns bel o w m ust be rec or de d as a n A E: 
 
Is ass ociate d wit h acc o m pa n yi n g s y m pt o ms. 
 
Re q uires a d diti o nal dia g n ostic testi n g or me dical/s ur gical i nter ve nti o n . 
 
Lea ds t o a c ha n ge i n st u d y d osi n g ( o utsi de of a n y pr ot oc ol -s pecifie d d ose 
a dj ust me nts) or disc o nti n uati o n fr o m t he st u d y, si g nifica nt a d diti o nal 
c o nc o mita nt dr u g treat me nt, or ot her t hera p y . 
•  E xacer bati o n of a c hr o nic or i nter mitte nt pree xisti n g c o n diti o n , i ncl u di n g a n 
i ncrease i n eit her fre q ue nc y a n d/ or i nte nsit y of t he c o n diti o n. 
•  Ne w c o n diti o n detecte d or dia g n ose d after st u d y i nter ve nti o n a d mi nistrati o n , e ve n 
t h o u g h it ma y ha ve bee n prese nt bef ore t he start of t he st u d y. 
•  Si g ns, s y m pt o ms, or t he cli nical se q uelae of a s us pecte d dr u g -dr u g i nteracti o n.  
•  Si g ns, s y m pt o ms, or t he cli nical se q uelae of a s us pecte d o ver d ose of eit her st u d y 
i nter ve nti o n or a c o nc o mita nt me dicati o n. O ver d ose per se will n ot be re p orte d as 
a n A E or S A E u nless it is a n i nte nti o nal o ver d ose ta ke n wit h p ossi ble s uici dal/self-
har mi n g i nte nt. S uc h o ver d oses s h o ul d be re p orte d re gar dless of se q uelae.  
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 8 5  
E ve nts N O T  Meeti n g t he A E Defi niti o n  
•  A n y cli nicall y si g nifica nt a b n or mal la b orat or y fi n di n gs or ot her a b n or mal safet y 
assess me nts t hat are ass ociate d wit h t he u n derl yi n g disease, u nless j u d ge d b y t he 
i n vesti gat or t o be m ore se vere t ha n e x pecte d f or t he partici pa nt’s c o n diti o n. 
•  T he disease/ dis or der bei n g st u die d or e x pecte d pr o gressi o n, si g ns, or s y m pt o ms of 
t he disease/ dis or der bei n g st u die d, u nless m ore se vere t ha n e x pecte d f or t he 
partici pa nt’s c o n diti o n.  
•  Me dical or s ur gical pr oce d ure ( e g, e n d osc o p y, a p pe n dect o m y): t he c o n diti o n t hat 
lea ds t o t he pr oce d ure is t he A E. 
•  Sit uati o ns i n w hic h a n u nt o war d me dical occ urre nce di d n ot occ ur (s ocial a n d/ or 
c o n ve nie nce a d missi o n t o a h os pital).  
•  A ntici pate d da y -t o-da y fl uct uati o ns of pree xisti n g disease(s) or c o n diti o n(s) prese nt 
or detecte d at t he start of t he st u d y t hat d o n ot w orse n.  
1 0. 3. 2.  Defi niti o n of a n S A E  
A n  S A E is defi ne d as a n y u nt o w ar d me dic al occ urre nce t h at, at a n y d ose , meets o ne 
or m ore of t he criteri a liste d bel o w : 
a.  Res ults i n de at h  
b.  Is life-t hre ate ni n g 
T he ter m “life-t hreate ni n g” i n t he defi niti o n of “seri o us” refers t o a n e ve nt i n w hic h t he 
partici pa nt was at ris k of deat h at t he ti me of t he e ve nt.  It d oes n ot refer t o a n e ve nt t hat 
h y p ot heticall y mi g ht ha ve ca use d deat h if it were m ore se vere.  
c. Re q uires i n p atie nt h os pit aliz ati o n or pr ol o n g ati o n of e xisti n g h os pit aliz ati o n  
I n ge neral, h os pitalizati o n si g nifies t hat t he partici pa nt has bee n a d mitte d ( us uall y 
i n v ol vi n g at least a n o ver ni g ht sta y) at t he h os pital or e mer ge nc y war d f or o bser vati o n 
a n d/ or treat me nt t hat w o ul d n ot ha ve bee n a p pr o priate i n t he p h ysicia n’s office or 
o ut patie nt setti n g.  C o m plicati o ns t hat occ ur d uri n g h os pitalizati o n are A E s. If a 
c o m plicati o n pr ol o n gs h os pitalizati o n or f ulfills a n y ot her seri o us criteria, t he e ve nt is 
seri o us. W he n i n d o u bt as t o w het her “ h os pitalizati o n” occ urre d or was necessar y, t he 
A E s h o ul d be c o nsi dere d seri o us.  
H os pitalizati o n f or electi ve treat me nt of a pree xisti n g c o n diti o n t hat di d n ot w orse n 
fr o m baseli ne is n ot c o nsi dere d a n A E. 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 8 6  
d.  Res ults i n persiste nt or si g nific a nt dis a bilit y/i nc a p acit y  
•  T he ter m disa bilit y mea ns a s u bsta ntial disr u pti o n of a pers o n’s a bilit y t o c o n d uct 
n or mal life f u ncti o ns.  
•  T his defi niti o n is n ot i nte n de d t o i ncl u de e x perie nces of relati vel y mi n or me dical 
si g nifica nce, s uc h as u nc o m plicate d hea dac he, na usea, v o miti n g, diarr hea, 
i nfl ue nza, a n d acci de ntal tra u ma (e g, s prai ne d a n kle), t hat ma y i nterfere wit h or 
pre ve nt e ver y da y life f u ncti o ns b ut d o n ot c o nstit ute a s u bsta ntial disr u pti o n.  
e. Is a c o n ge nit al a n o m al y/ birt h defect 
f. Is a s us pecte d tr a ns missi o n vi a a K a n y os  Bi o, I nc.  pr o d uct of a n i nfecti o us a ge nt, 
p at h o ge nic or n o n p at h o ge nic   
T he e ve nt ma y be s us pecte d fr o m cli nical s y m pt o ms or la b orat or y fi n di n gs i n dicati n g 
a n i nfecti o n i n a partici pa nt  e x p ose d t o a Ka n y os  Bi o, I nc.  pr o d uct. T he ter ms 
“s us pecte d tra ns missi o n” a n d “tra ns missi o n” are c o nsi dere d s y n o n y m o us. T hese cases 
are c o nsi dere d u ne x pecte d a n d ha n dle d as seri o us e x pe dite d cases b y 
p har mac o vi gila nce pers o n nel. S uc h cases are als o c o nsi dere d f or re p orti n g as pr o d uct 
d efects, if a p pr o priate.  
g.  Ot her sit u ati o ns:  
•  Me dical or scie ntific j u d g me nt s h o ul d be e xercise d b y t he i n vesti gat or i n deci di n g 
w het her S A E re p orti n g is a p pr o priate i n ot her sit uati o ns , s uc h as si g nifica nt 
me dical e ve nts t hat ma y je o par dize t he partici pa nt or ma y re q uire me dical or 
s ur gical i nter ve nti o n t o pre ve nt o ne of t he ot her o utc o mes liste d i n t he a b o ve 
defi niti o n.  T hese e ve nts s h o ul d us uall y be c o nsi dere d seri o us.  
•  E xa m ples of s uc h e ve nts i ncl u de i n vasi ve or mali g na nt ca ncers, i nte nsi ve treat me nt 
i n a n e mer ge nc y r o o m or at h o me f or aller gic br o nc h os pas m, bl o o d d yscrasias or 
c o n v ulsi o ns t hat d o n ot res ult i n h os pitalizati o n, or de vel o p me nt of dr u g 
de pe n de nc y or dr u g a b use.  
 
 
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 8 7  
1 0. 3. 3.  Rec or di n g / Re p orti n g a n d F oll o w -U p of A E s a n d/ or S A E s D uri n g t he Acti ve 
C olle cti o n Peri o d  
A E a n d S A E Rec or di n g / Re p orti n g 
T he ta ble bel o w s u m marizes t he re q uire me nts f or rec or di n g A E s o n t he C R F a n d f or 
re p orti n g S A E s o n t he C T  S A E Re p ort F or m t o Pfizer Safet y  t hr o u g h o ut t he acti ve 
c ollecti o n peri o d . T hese re q uire me nts are deli neate d f or 3 t y pes of e ve nts: ( 1) S A Es; ( 2) 
n o nseri o us A E s; a n d ( 3) e x p os ure t o t he st u d y i nter ve nti o n u n der st u d y d uri n g pre g na nc y 
or breastfee di n g, a n d occ u pati o nal e x p os ure.  
It s h o ul d be n ote d t hat t he C T S A E Re p ort F or m f or re p orti n g of S A E i nf or mati o n is n ot 
t he sa me as t he A E pa ge of t he C R F. W he n t he sa me data are c ollecte d, t he f or ms m ust be 
c o m plete d i n a c o nsiste nt ma n ner. A E s s h o ul d be rec or de d usi n g c o ncise me dical 
ter mi n ol o g y a n d t he sa me A E ter m s h o ul d be use d o n b ot h t he C R F a n d t he C T S A E 
Re p ort F or m f or re p orti n g of S A E i nf or mati o n.  
S afet y E ve nt  
Rec or de d o n t he C R F  
Re p orte d o n t he C T S A E 
Re p ort F or m t o Pfizer 
S afet y  Wit hi n 2 4 H o urs of 
A w are ness  
S A E  
All  
All  
N o nseri o us A E  
All  
N o ne  
E x p os ure t o t he st u d y 
i nter ve nti o n u n der st u d y 
d uri n g pre g na nc y or 
breastfee di n g  
All A E s or S A Es ass ociate d 
wit h E D P  or E D B  
 
N ote: I nsta nces of E D P or 
E D B n ot ass ociate d wit h a n 
A E or S A E are n ot ca pt ure d 
i n t he C R F 
All i nsta nces of E D P are 
re p orte d ( w het her or n ot 
t here is a n ass ociate d 
S A E) *  
All i nsta nces of E D B are 
re p orte d ( w het her or n ot 
t here is a n ass ociate d 
S A E) * *  
E n vir o n me ntal or 
occ u pati o nal e x p os ure t o 
t he pr o d uct u n der st u d y t o 
a n o n partici pa nt ( n ot 
i n v ol vi n g E D P or E D B) 
N o ne. E x p os ure t o a st u d y 
n o n partici pa nt is n ot 
c ollecte d o n t he C R F  
T he e x p os ure ( w het her or 
n ot t here is a n ass ociate d 
A E or S A E) m ust be 
re p orte d * * * 
*  
E D P  ( wit h or wit h o ut a n ass ociate d A E or S A E): a n y pre g na nc y i nf or mati o n is re p orte d t o Pfizer 
Safet y  usi n g t he C T S A E Re p ort F or m a n d E D P S u p ple me ntal F or m; if t he E D P is ass ociate d wit h a n 
S A E, t he n t he S A E is re p orte d t o Pfizer Safet y  usi n g t he C T S A E Re p ort F or m.  
* *  E D B  is re p orte d t o Pfizer Safet y  usi n g t he C T S A E Re p ort F or m , w hic h w o ul d als o i ncl u de details 
of a n y S A E t hat mi g ht be ass ociate d wit h t he E D B.  
* * *  E n vir o n me nt al or o cc u p ati o n al e x p os ure:  A E s or S A Es ass ociate d wit h occ u pati o nal e x p os ure 
are re p orte d t o Pfizer Safet y  usi n g t he C T S A E Re p ort F or m.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 8 8  
•  W he n a n A E  or S A E occ urs, it is t he res p o nsi bilit y of t he i n vesti gat or t o re vie w all 
d oc u me ntati o n (e g, h os pital pr o gress n otes, la b orat or y re p orts, a n d dia g n ostic 
re p orts) relate d t o t he e ve nt. 
•  T he i n vesti gat or will t he n rec or d all rele va nt A E  or S A E i nf or mati o n i n t he C R F.  
•  It is n ot  acce pta ble f or t he i n vesti gat or t o se n d p h ot oc o pies of t he partici pa nt’s 
me dical rec or ds t o Pfizer S afet y i n lie u of c o m pleti o n of t he C T S A E Re p ort 
F or m / A E or S A E C R F pa ge.  
•  T here ma y be i nsta nces w he n c o pies of me dical rec or ds f or certai n cases are 
re q ueste d b y t he s p o ns or/Pfizer Safet y . I n t his case, all partici pa nt i de ntifiers, wit h 
t he e xce pti o n of t he partici pa nt n u m ber, will be re dacte d o n t he c o pies of t he 
me dical rec or ds bef ore s u b missi o n t o Pfizer Safet y . 
•  T he i n vesti gat or will atte m pt t o esta blis h a dia g n osis of t he e ve nt base d o n si g ns, 
s y m pt o ms, a n d/ or ot her cli nical i nf or mati o n. W he ne ver p ossi ble, t he dia g n osis ( n ot 
t he i n di vi d ual si g ns/s y m pt o ms) will be d oc u me nte d as t he A E or S A E.  
Assess me nt of I nte nsit y  
T he i n vesti gat or will ma ke a n assess me nt of i nte nsit y f or eac h A E a n d S A E re p orte d 
d uri n g t he st u d y a n d assi g n it t o 1 of t he cate g ories liste d bel o w (as defi ne d b y t he N CI 
C T C A E s yste m).  
G R A D E  Cli nical Descri pti o n of I nte nsit y  
1  
MI L D A E  
2  
M O D E R A T E A E  
3  
S E V E R E A E  
4  
LI F E -T H R E A T E NI N G; ur ge nt i nter ve nti o n i n dicate d  
5  
D E A T H R E L A T E D T O A E  
 
F urt her details re gar di n g t he C T C A E are prese nte d i n A p pe n di x 1 0 . 
A n e ve nt is defi ne d as “seri o us” w he n it meets at least 1 of t he pre defi ne d o utc o mes as 
descri be d i n t he defi niti o n of a n S A E, N O T w he n it is rate d as se vere.  
 
Assess me nt of C a us alit y  
•  T he i n vesti gat or is o bli gate d t o assess t he relati o ns hi p bet wee n st u d y i nter ve nti o n 
a n d eac h occ urre nce of eac h A E  or S A E.  T he i n vesti gat or will use cli nical 
j u d g me nt t o deter mi ne t he relati o ns hi p. 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 8 9  
•  A “reas o na ble p ossi bilit y” of a relati o ns hi p c o n ve ys t hat t here are facts, e vi de nce, 
a n d/ or ar g u me nts t o s u g gest a ca usal relati o ns hi p, rat her t ha n a relati o ns hi p ca n n ot 
be r ule d o ut.  
•  Alter nati ve ca uses, s uc h as u n derl yi n g disease(s), c o nc o mita nt t hera p y, a n d ot her 
ris k fact ors, as well as t he te m p oral relati o ns hi p of t he e ve nt t o st u d y i nter ve nti o n 
a d mi nistrati o n , will be c o nsi dere d a n d i n vesti gate d.  
•  T he i n vesti gat or will als o c o ns ult t he I B a n d/ or p r o d uct inf or mati o n, f or mar kete d 
pr o d ucts, i n t heir assess me nt. 
•  F or eac h A E  or S A E, t he i n vesti gat or m ust  d oc u me nt i n t he me dical n otes t hat t he y 
ha ve  re vie we d t he A E or S A E a n d ha ve  pr o vi de d a n assess me nt of ca usalit y.  
•  T here ma y be sit uati o ns i n w hic h a n S A E has occ urre d a n d t he i n vesti gat or has 
mi ni mal i nf or mati o n t o i ncl u de i n t he i nitial re p ort t o Pfizer Safet y . H o we ver, it is 
ver y i m p ort a nt t h at t he i n vesti g at or al w a ys m a ke a n assess me nt of c a us alit y 
f or e ver y e ve nt bef ore t he i niti al tr a ns missi o n of t he S A E d at a t o Pfizer S afet y . 
•  T he i n vesti gat or ma y c ha n ge t heir o pi ni o n of ca usalit y i n li g ht of f oll o w -u p 
i nf or mati o n a n d se n d an  S A E f oll o w -u p re p ort wit h t he u p date d ca usalit y 
assess me nt. 
•  T he ca usalit y assess me nt is o ne of t he criteria use d w he n deter mi ni n g re g ulat or y 
re p orti n g re q uire me nts. 
•  If t he i n vesti gat or d oes n ot k n o w w het her or n ot t he st u d y i nter ve nti o n ca use d t he 
e ve nt, t he n t he e ve nt will be ha n dle d as “relate d t o st u d y i nter ve nti o n” f or re p orti n g 
p ur p oses, as defi ne d b y Pfizer Safet y . I n a d diti o n, if t he i n vesti gat or deter mi nes 
t hat a n S A E is ass ociate d wit h st u d y pr oce d ures, t he i n vesti gat or m ust rec or d t his 
ca usal relati o ns hi p i n t he s o urce d oc u me nts a n d C R F, a n d re p ort s uc h a n 
assess me nt i n t he de dicate d secti o n of t he C T S A E Re p ort F or m a n d i n acc or da nce 
wit h t he S A E re p orti n g re q uire me nts.  
 
F oll o w -U p of A Es  a n d S A Es  
•  T he i n vesti gat or is o bli gate d t o perf or m or arra n ge f or t he c o n d uct of s u p ple me ntal 
meas ure me nts a n d/ or e val uati o ns , as me dicall y i n dicate d or as re q ueste d b y t he 
sp o ns or / Pfizer Safet y, t o el uci date t he nat ure a n d/ or ca usalit y of t he A E or S A E as 
f ull y as p ossi ble. T his ma y i ncl u de a d diti o nal la b orat or y tests or i n vesti gati o ns, 
hist o pat h ol o gical e xa mi nati o ns, or c o ns ultati o n wit h ot her healt hcare pr o vi ders . 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 9 0  
•  If a partici pa nt dies d uri n g partici pati o n i n t he st u d y or d uri n g a rec o g nize d f oll o w-
u p peri o d, t he i n vesti gat or will pr o vi de Pfizer Safet y wit h a c o p y of a n y 
p ost m orte m fi n di n gs , i ncl u di n g hist o pat h ol o g y. 
•  Ne w or u p date d i nf or mati o n will be rec or de d i n t he ori gi nall y s u b mitte d 
d oc u me nts . 
•  T he i n vesti gat or will s u b mit a n y u p date d S A E data t o Pfizer Safet y  wit hi n 2 4 h o urs 
of recei pt of t he i nf or mati o n.  
1 0. 3. 4.  Re p orti n g of S A Es  
S A E Re p orti n g t o Pfizer S afet y  vi a a n Electr o nic D C T  
•  T he pri mar y mec ha nis m f or re p orti n g a n S A E t o Pfizer Safet y  will be t he 
electr o nic D C T . 
•  If t he electr o nic s yste m is u na vaila ble, t he n t he site will use t he pa per S A E D C T  
(see ne xt secti o n) t o re p ort t he e ve nt wit hi n 2 4 h o urs. 
•  T he site will e nter t he S A E data i nt o t he electr o nic  D C T  (e g, e S A E or P S S A) or 
pa per f or m (as a p plica ble)  as s o o n as t he data  bec o me a vaila ble.  
•  After t he st u d y is c o m plete d at a gi ve n site, t he electr o nic D C T  will be ta ke n 
off -li ne t o pre ve nt t he e ntr y of ne w data or c ha n ges t o e xisti n g data. 
•  If a site recei ves a re p ort of a ne w S A E fr o m a st u d y partici pa nt or recei ves u p date d 
data o n a pre vi o usl y re p orte d S A E after t he electr o nic D C T  has bee n ta ke n off -li ne, 
t he n t he site ca n re p ort t his i nf or mati o n o n a pa per S A E f or m (see ne xt secti o n) or 
t o Pfizer Safet y  b y tele p h o ne.  
 
S A E Re p orti n g t o Pfizer S afet y  vi a t he C T S A E Re p ort F or m  
•  Facsi mile tra ns missi o n of t he C T S A E Re p ort F or m  is o ne of t he preferre d met h o ds 
t o tra ns mit t his i nf or mati o n t o Pfizer Safet y . 
•  I n circ u msta nces w he n t he fac si mile is n ot w or ki n g, a n alter nati ve met h o d s h o ul d 
be use d, e g, sec ure d ( Tra ns p ort La yer Sec urit y) or pass w or d-pr otecte d e mail. If 
n o ne of t hese met h o ds ca n be use d, n otificati o n b y tele p h o ne is acce pta ble wit h a 
c o p y of t he C T S A E Re p ort F or m se nt b y o ver ni g ht mail or c o urier ser vice. 
•  I nitial n otificati o n via tele p h o ne d oes n ot re place t he nee d f or t he i n vesti gat or t o 
c o m plete a n d si g n t he C T S A E Re p ort F or m pa ges wit hi n t he desi g nate d re p orti n g 
ti me fra mes. 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 9 1  
1 0. 4.  A p pe n di x 4: C o ntr ace pti ve a n d B arrier G ui d a nce  
1 0. 4. 1.  M ale P artici p a nt Re pr o d ucti ve I ncl usi o n Criteri a  
Male partici pa nts are eli gi ble t o partici pate if t he y a gree t o t he f oll o wi n g re q uire me nts d uri n g 
t he i nter ve nti o n peri o d a n d f or at least 2 1 da ys  after t he last d ose of st u d y i nter ve nti o n , w hic h 
c orres p o n ds t o t he ti me nee de d t o eli mi nate re pr o d ucti ve safet y ris k of t he st u d y 
i nter ve nti o n(s): 
•  Refrai n fr o m d o nati n g s per m . 
P L U S eit her:  
•  Be a bsti ne nt fr o m heter ose x ual  or h o m ose x ual i nterc o urse as t heir preferre d a n d us ual 
lifest yle (a bsti ne nt o n a l o n g-ter m a n d persiste nt basis) a n d a gree t o re mai n a bsti ne nt.  
O R  
•  M ust a gree t o use a male c o n d o m w he n e n ga gi n g i n a n y acti vit y t hat all o ws f or 
passa ge of ejac ulate t o a n ot her pers o n . 
•  T he m ale partici pa nt s h o ul d be a d vise d of t he be nefit f or a W O C B P  part ner us i n g a 
hi g hl y effecti ve met h o d of c o ntrace pti o n  wit h a fail ure rate of < 1 % per year, as 
descri be d i n Secti o n 1 0. 4. 4 . 
1 0. 4. 2.  Fe m ale P artici p a nt Re pr o d ucti ve I ncl usi o n Criteri a  
T he criteria bel o w are part of I ncl usi o n Criteri o n 1 ( A ge a n d Se x; Secti o n 5. 1 ) a n d s pecif y 
t he re pr o d ucti ve re q uire me nts f or i ncl u di n g fe male partici pa nts. Refer t o Secti o n 1 0. 4. 4  f or a 
c o m plete list of c o ntrace pti ve met h o ds per mitte d i n t he st u d y.  
•  A fe male partici pa nt is eli gi ble t o partici pate if s he (a) is n ot pre g na nt or breastfee di n g; 
a n d ( b) a grees n ot t o d o nate e g gs ( o va, o oc ytes) f or t he p ur p ose of re pr o d ucti o n f or 2 1  
da ys  after t he last d ose of st u d y i nter ve nti o n ; a n d (c) at least 1  of t he f oll o wi n g c o n diti o ns 
a p plies: 
•  Is n ot a W O C B P (see defi niti o n i n Secti o n 1 0. 4. 3 ). 
O R  
•  Is a W O C B P a n d a grees t o use a c o ntrace pti ve met h o d t hat is hi g hl y effecti ve (fail ure 
rate of < 1 % per year) wit h l o w user de pe n de nc y d uri n g t he i nter ve nti o n peri o d a n d 
a grees t o use it f or at least 2 1 da ys after t he last d ose of st u d y i nter ve nti o n,  w hic h 
c orres p o n ds t o t he ti me nee de d t o eli mi nate a n y re pr o d ucti ve safet y ris k of t he st u d y 
i nter ve nti o n(s). T he i n vesti gat or s h o ul d e val uate t he effecti ve ness of t he 
c o ntrace pti ve met h o d i n relati o ns hi p t o t he first d ose of st u d y i nter ve nti o n.  
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 9 2  
O R  
•  Is a W O C B P a n d a grees t o use a hi g hl y effecti ve (fail ure rate of < 1 % per year) user-
de pe n de nt met h o d of c o ntrace pti o n d uri n g t he i nter ve nti o n peri o d a n d f or at least 2 1 
da ys after t he last d ose of st u d y i nter ve nti o n, w hic h c orres p o n ds t o t he ti me nee de d t o  
eli mi nate a n y re pr o d ucti ve safet y ris k of t he st u d y i nter ve nti o n(s).  I n a d diti o n t o her 
use of t he hi g hl y effecti ve met h o d a b o ve, s he a grees t o c o nc urre ntl y use a n effecti ve 
barrier met h o d. T he i n vesti gat or s h o ul d e val uate t he effecti ve ness of t he 
c o ntrace pti ve met h o d i n relati o ns hi p t o t he first d ose of st u d y i nter ve nti o n.  
T he i n vesti gat or is res p o nsi ble f or re vie w of me dical hist or y, me nstr ual hist or y, a n d rece nt 
se x ual acti vit y t o decrease t he ris k f or i ncl usi o n of a w o ma n wit h a n earl y u n detecte d 
pre g na nc y.  
1 0. 4. 3.  W o m a n  of C hil d be ari n g P ote nti al  
A w o ma n is c o nsi dere d fertile f oll o wi n g me narc he a n d u ntil bec o mi n g p ost me n o pa usal 
u nless per ma ne ntl y sterile (see bel o w).  
If fertilit y is u nclear (e g, a me n orr hea or oli g o me n orr hea ) a n d a me nstr ual c ycle ca n n ot be 
c o nfir me d bef ore t he first d ose of st u d y i nter ve nti o n, a d diti o nal e val uati o n s h o ul d be 
c o nsi dere d. 
Wo me n i n t he f oll o wi n g cate g ories are n ot  c o nsi dere d W O C B P:  
1.  Pre me n o pa usal fe male wit h 1 of t he f oll o wi n g:   
•  D oc u me nte d h ysterect o m y;  
•  D oc u me nte d bilateral sal pi n gect o m y;  
•  D oc u me nte d bilateral o o p h orect o m y.  
F or i n di vi d uals wit h per ma ne nt i nfertilit y d ue t o a me dical ca use ot her t ha n t he a b o ve  (e g, 
m ulleria n a ge nesis, a n dr o ge n i nse nsiti vit y), i n vesti gat or discreti o n s h o ul d be a p plie d t o 
deter mi ni n g st u d y e ntr y.  
N ote: D oc u me ntati o n f or a n y of t he a b o ve cate g ories ca n c o me fr o m t he site pers o n nel’s 
re vie w of t he partici pa nt’s me dical rec or ds, me dical e xa mi nati o n, or me dical hist or y 
i nter vie w. T he met h o d of d oc u me ntati o n s h o ul d be rec or de d i n t he partici pa nt’s me dical 
rec or d f or t he st u d y. 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 9 3  
2. P ost me n o pa usal fe male : 
•  A p ost me n o pa usal state is defi ne d as n o me nses f or 1 2  m o nt hs wit h o ut a n alter nati ve 
me dical ca use.  I n a d diti o n: 
•  A hi g h F S H le vel i n t he p ost me n o pa usal ra n ge m ust be use d t o c o nfir m a 
p ost me n o pa usal state i n w o me n  u n der 6 0 years of a ge a n d  n ot usi n g h or m o nal 
c o ntrace pti o n or H R T.  
•  A f e male o n H R T a n d w h ose me n o pa usal stat us is i n d o u bt will be re q uire d t o use 
o ne of t he hi g hl y effecti ve n o nestr o ge n h or m o nal c o ntrace pti o n met h o ds if s he 
wis h es t o c o nti n ue her  H R T d uri n g t he st u d y.  Ot her wise, s he m ust disc o nti n ue H R T 
t o all o w c o nfir mati o n of p ost me n o pa usal stat us bef ore st u d y e nr oll me nt. 
1 0. 4. 4.  C o ntr ace pti o n  Met h o ds  
C o ntrace pti ve use b y me n or w o me n s h o ul d be c o nsiste nt wit h l ocal a vaila bilit y/re g ulati o ns 
re gar di n g t he use of c o ntrace pti ve met h o ds f or t h ose partici pati n g i n cli nical trials. 
T he f oll o wi n g c o ntrace pti ve met h o ds are a p pr o priate f or t his st u d y:  
Hi g hl y Effecti ve Met h o ds T hat H a ve L o w User De pe n de nc y  
1.  I m pla nta ble pr o gest o ge n-o nl y h or m o ne c o ntrace pti o n ass ociate d wit h i n hi biti o n of 
o v ulati o n.  
2.  I ntra uteri ne de vice. 
3.  I ntra uteri ne h or m o ne-releasi n g s yste m. 
4.  Bilateral t u bal occl usi o n.  
5.  Vasect o mize d part ner.  
•  Vasect o mize d part ner is a hi g hl y effecti ve c o ntrace pti ve met h o d pr o vi de d t hat t he 
part ner is t he s ole se x ual part ner of t he W O C B P a n d t he a bse nce of s per m has 
bee n c o nfir me d. If n ot, a n a d diti o nal hi g hl y effecti ve met h o d of c o ntrace pti o n 
s h o ul d be use d. T he s per mat o ge nesis c ycle is a p pr o xi matel y 9 0 da ys.  
Hi g hl y Effecti ve Met h o ds T hat Are User De pe n de nt  
6.  C o m bi ne d (estr o ge n - a n d pr o gest o ge n -c o ntai ni n g) h or m o nal c o ntrace pti o n ass ociate d 
wit h i n hi biti o n of o v ulati o n:  
•  Oral  
•  I ntra va gi nal  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 9 4  
•  Tra ns der mal  
7.  Pr o gest o ge n -o nl y h or m o ne c o ntrace pti o n ass ociate d wit h i n hi biti o n of o v ulati o n:  
•  Oral  
•  I njecta ble  
8.  Se x ual a bsti ne nce  
•  Se x ual a bsti ne nce is c o nsi dere d a hi g hl y effecti ve met h o d o nl y if defi ne d as 
refrai ni n g fr o m heter ose x ual i nterc o urse d uri n g t he e ntire peri o d of ris k 
ass ociate d wit h t he st u d y i nter ve nti o n. T he relia bilit y of se x ual a bsti ne nce 
nee ds t o be e val uate d i n relati o n t o t he d urati o n of t he st u d y a n d t he preferre d 
a n d us ual lifest yle of t he partici pa nt.  
 
 
 
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 9 5  
1 0. 5.  A p pe n di x 5: Ge netics  
Use/ A n al ysis of D N A  
•  Ge netic variati o n ma y i m pact a partici pa nt’s res p o nse t o st u d y i nter ve nti o n, 
s usce pti bilit y t o, a n d se verit y a n d pr o gressi o n of disease. T heref ore, w here l ocal 
re g ulati o ns a n d I R Bs/ E Cs all o w, a bl o o d sa m ple will be c ollecte d f or D N A a nal ysis. 
•  T he res ults of ge netic a nal yses ma y be re p orte d i n t he C S R or i n a se parate st u d y 
s u m mar y, or ma y be use d f or i nter nal decisi o n ma ki n g wit h o ut bei n g i ncl u de d i n a 
st u d y re p ort. 
•  T he s p o ns or or desi g nee will st ore t he D N A sa m ples i n a sec ure st ora ge s pace wit h 
a de q uate meas ures t o pr otect c o nfi de ntialit y.  
•  T he sa m ples will be retai ne d as i n dicate d:  
•  Sa m ples f or s pecifie d ge netic a nal ysis (see  Secti o n 8. 6. 1  a n d Secti o n 8. 7. 1 ) will 
n ot be st ore d be y o n d t he c o m pleti o n of t his st u d y (e g, C S R fi nalizati o n ). 
•  
Sa m ples f or ge netic researc h will be la bele d wit h a c o de. T he ke y bet wee n t he c o de 
a n d t he partici pa nt’s pers o nall y i de ntif yi n g i nf or mati o n (e g, na me, a d dress) will be 
hel d sec urel y at t he st u d y site.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 9 6  
1 0. 6.  A p pe n di x 6 : Li ver S afet y: S u g geste d Acti o ns a n d F oll o w-U p Assess me nts  
P ote nti al C ases of Dr u g -I n d uce d Li ver I nj ur y 
H u ma ns e x p ose d t o a dr u g w h o s h o w n o si g n of li ver i nj ur y (as deter mi ne d b y ele vati o ns i n 
tra nsa mi nases) are ter me d “t olerat ors,” w hile t h ose w h o s h o w tra nsie nt li ver i nj ur y b ut a da pt 
are ter me d “a da pt ors.” I n s o me partici pa nt s, tra nsa mi nase ele vati o ns are a har bi n ger of a 
m ore seri o us p ote ntial o utc o me. T hese partici pa nt s fail t o a da pt a n d t heref ore are 
“s usce pti ble” t o pr o gressi ve a n d seri o us li ver i nj ur y, c o m m o nl y referre d t o as DI LI. 
Partici pa nt s w h o e x perie nce a tra nsa mi nase ele vati o n a b o ve 3 × U L N s h o ul d be m o nit ore d 
m ore fre q ue ntl y t o deter mi ne if t he y are “a da pt or s” or are “s usce pti ble.”  
I n t he maj orit y of DI LI cases, ele vati o ns i n A S T a n d/ or A L T prece de T b ili ele vati o ns ( > 2 × 
U L N) b y se veral da ys or wee ks. T he i ncrease i n T  b ili t y picall y occ urs w hile A S T/ A L T is/are 
still ele vate d a b o ve 3 × U L N (ie, A S T/ A L T a n d T b ili val ues will be ele vate d wit hi n t he sa me 
la borat or y  sa m ple). I n rare i nsta nces, b y t he ti me T b ili ele vati o ns are detecte d, A S T/ A L T 
val ues mi g ht ha ve decrease d. T his occ urre nce is still re gar de d as a p ote ntial DI LI. T heref ore, 
a b n or mal ele vati o ns i n eit her A S T O R A L T i n a d diti o n t o T  b ili t hat meet t he criteria o utli ne d 
bel o w are c o nsi dere d p ote ntial DI LI (assesse d per H y’s la w criteria) cases  a n d s h o ul d al wa ys 
be c o nsi dere d i m p orta nt me dical e ve nts, e ve n bef ore all ot her p ossi ble ca uses of li ver i nj ur y 
ha ve bee n e xcl u de d.  
T he t hres h ol d of la b orat or y a b n or malities f or a p ote ntial DI LI case de pe n ds o n t he 
partici pa nt ’s i n di vi d ual baseli ne val ues a n d u n derl yi n g c o n diti o ns. Partici pa nt s w h o prese nt 
wit h t he f oll o wi n g la b orat or y a b n or malities s h o ul d be e val uate d f urt her as p ote ntial DI LI 
( H y’s la w) cases t o defi niti vel y deter mi ne t he eti ol o g y of t he a b n or mal la b orat or y val ues: 
•  Partici pa nt s wit h A S T/ A L T a n d T b ili baseli ne val ues wit hi n t he n or mal ra n ge w h o 
s u bse q ue ntl y prese nt wit h A S T O R A L T val ues ≥3 × U L N A N D a T  b ili val ue 
≥2  ×  U L N wit h n o e vi de nce of he m ol ysis a n d a n al kali ne p h os p hatase val ue 
< 2  ×  U L N or n ot a vaila ble.  
•  F or partici pa nt s wit h baseli ne A S T O R A L T O R  T  b ili val ues a b o ve t he U L N, t he 
f oll o wi n g t hres h ol d val ues are use d i n t he defi niti o n me nti o ne d a b o ve, as nee de d, 
de pe n di n g o n w hic h val ues are a b o ve t he U L N at baseli ne:  
•  Pree xisti n g A S T or A L T baseli ne val ues a b o ve t he n or mal ra n ge:  A S T or 
A L T val ues ≥2  ti mes t he baseli ne val ues A N D ≥3 ×  U L N; or ≥8  ×  U L N 
( w hic he ver is s maller). 
•  Pree xisti n g val ues of T  b ili a b o ve t he n or mal ra n ge: T b ili le vel i ncrease d 
fr o m baseli ne val ue b y a n a m o u nt of ≥1 × U L N or  if t he val ue reac hes 
≥3  ×  U L N ( w hic he ver is s maller).    
Rises i n A S T/ A L T a n d T  b ili se parate d b y m ore t ha n a fe w wee ks s h o ul d be assesse d 
i n di vi d uall y base d o n cli nical j u d g me nt; a n y case w here u ncertai nt y re mai ns as t o w het her it 
re prese nts a p ote ntial H y’s la w case s h o ul d be re vie we d wit h t he s p o ns or or desi g nee .  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 9 7  
T he partici pa nt  s h o ul d ret ur n t o t he i n vesti gat or site a n d be e val uate d as s o o n as p ossi ble, 
prefera bl y wit hi n 4 8  h o urs fr o m a ware ness of t he a b n or mal res ults. T his e val uati o n s h o ul d 
i ncl u de la b orat or y tests, detaile d hist or y, a n d p h ysical assess me nt.  
I n a d diti o n t o re peati n g meas ure me nts of A S T a n d A L T a n d T b ili f or s us pecte d H y’s la w 
cases , a d diti o nal la b orat or y tests s h o ul d i ncl u de al b u mi n, C K, direct a n d i n direct bilir u bi n, 
G G T, P T/I N R,  e osi n o p hils  ( %), a n d al kali ne p h os p hatase. C o nsi derati o n s h o ul d als o be 
gi ve n t o dra wi n g a se parate t u be of cl otte d bl o o d a n d a n a ntic oa g ulate d t u be of bl o o d f or 
f urt her testi n g, as nee de d, f or f urt her c o nte m p ora ne o us a nal yses at t he ti me of t he rec o g nize d 
i nitial a b n or malities t o deter mi ne eti ol o gy. A detaile d hist or y, i ncl u di n g rele va nt i nf or mati o n, 
s uc h as re vie w of et ha n ol, aceta mi n o p he n/ paraceta m ol (eit her b y itself or as a c of or m ulate d 
pr o d uct i n prescri pti o n or o ver -t he-c o u nter me dicati o ns), recreati o nal dr u g, or s u p ple me nt 
( her bal) use a n d co ns u m pti o n, fa mil y hist or y, se x ual hist or y, tra vel hist or y, hist or y of c o ntact 
wit h a ja u n dice d pers o n, s ur ger y, bl o o d tra nsf usi o n, hist or y of li ver or aller gic disease, a n d 
p ote ntial occ u pati o nal e x p os ure t o c he micals, s h o ul d be c ollecte d. F urt her testi n g  f or ac ute 
he patitis  A, B, C, D, a n d E i nfecti o n , t otal bile aci ds, li ver i ma gi n g (e g, biliar y tract), a n d 
c ollecti o n of ser u m sa m ple s f or aceta mi n o p he n/ paraceta m ol dr u g a n d/ or pr otei n a d d uct 
le vels ma y be warra nte d.  
All cases de m o nstrate d o n re peat testi n g as meeti n g t he la b orat or y criteria of A S T/ A L T a n d 
T  b ili ele vati o n defi ne d a b o ve s h o ul d be c o nsi dere d p ote ntial DI LI ( H y’s la w) cases if n o 
ot her reas o n f or t he L F T a b n or malities has yet bee n f o u n d.  S uc h p ote nti al DI LI ( H y’s l a w) 
c ases are t o be re p orte d as S A Es, irres pecti ve of a v ail a bilit y of all t he res ults of t he 
i n vesti g ati o ns perf or me d t o deter mi ne eti ol o g y of t he L F T a b n or m alities.  
A p ote ntial DI LI ( H y’s la w) case bec o mes a c o nfir me d case o nl y after all res ults of 
reas o na ble i n vesti gati o ns ha ve bee n recei ve d a n d ha ve e xcl u de d a n alter nati ve eti ol o g y. 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 9 8  
1 0. 7.  A p pe n di x 7 : Ki d ne y S afet y M o nit ori n g G ui deli nes 
1 0. 7. 1.  L a b or at or y Assess me nt of C h a n ge i n Ki d ne y F u ncti o n a n d Detecti o n of Ki d ne y 
I nj ur y 
Sta n dar d ki d ne y safet y m o nit ori n g re q uires assess me nt of baseli ne a n d p ost baseli ne Screat 
meas ure me nt t o esti mate ki d ne y f u ncti o n  [ Screat-base d e G F R ] or creati ni ne cleara nce 
[e Cr Cl]). Baseli ne a n d p ost baseli ne Sc ys ma kes it feasi ble t o disti n g uis h A KI fr o m ot her 
ca uses of Scr eat i ncrease. If Screat i ncrease is c o nfir me d after baseli ne, t he n refle x 
meas ure me nt of Sc ys is i n dicate d.  
A D U L T S: C urre ntl y, 2 0 2 1 C K D -E PI e G F R e q uati o ns ( Screat -o nl y base d a n d c o m bi ne d 
Screat pl us Sc ys -base d) are vali d f or use i n a d ults o nl y. At baseli ne Screat a n d Sc ys val ues 
are nee de d t o calc ulate 2 0 2 1 C K D -E PI e G F R b y Screat -o nl y base d e q uati o n (see Ta ble i n 
Secti o n 1 0. 7. 2. 1 ) a n d b y c o m bi ne d Screat pl us Sc ys-base d e q uati o n. W he n p ost -baseli ne 
Screat i ncrease ≥0. 3 m g/ d L is c o nfir me d, t he n refle x Sc ys meas ure me nt is nee de d t o e na ble 
p ost -baseli ne c o m paris o n of e G F R c ha n ges ( Screat -o nl y base d e G F R a n d c o m bi ne d Screat 
pl us Sc ys e G F R).  
Re gar dless of w het her ki d ne y f u ncti o n m o nit ori n g tests are re q uire d as a r o uti ne safet y 
m o nit ori n g pr oce d ure i n t he st u d y, if t he i n vesti gat or or s p o ns or or s p o ns or’s desi g nee dee ms 
it necessar y t o f urt her assess ki d ne y safet y a n d q ua ntif y ki d ne y f u ncti o n, t he n t hese test 
res ults s h o ul d be ma na ge d a n d f oll o we d per sta n dar d of care. 
1 0. 7. 2.  A ge -S pecific Ki d ne y F u ncti o n C alc ul ati o n Rec o m me n d ati o ns  
1 0. 7. 2. 1.  A d ults ( 1 8 Y e ars a n d A b o ve) — 2 0 2 1 C K D -E PI E q u ati o ns  
2 0 2 1 C K D -
E PI            
Scr e at O nl y  
Scr e at 
( m g/ d L) 
Sc ys  
( m g/ L) 
Rec o m me n de d e G F R E q u ati o n  
Fe male  
if ≤0. 7 
N A  
e G F R = 1 4 3 × ( Scr eat/ 0. 7)-0. 2 4 1   ×  ( 0. 9 9 3 8) A ge  
Fe male  
if > 0. 7 
N A  
e G F R = 1 4 3 × ( Scr eat/ 0. 7)-1. 2 0 0   ×  ( 0. 9 9 3 8) A ge  
Male  
if ≤0. 9 
N A  
e G F R = 1 4 2 × ( Scr eat/ 0. 9)-0. 3 0 2   ×  ( 0. 9 9 3 8) A ge  
Male  
if > 0. 9 
N A  
e G F R = 1 4 2 × ( Scr eat/ 0. 9)-1. 2 0 0   ×  ( 0. 9 9 3 8) A ge  
2 0 2 1 C K D -
E PI           
Scr e at-Sc ys 
C o m bi ne d  
Scr e at 
( m g/ d L) 
Sc ys  
( m g/ L) 
Rec o m me n de d e G F R E q u ati o n  
Fe male  
if ≤0. 7 
if ≤0. 8 
e G F R = 1 3 0 × ( Scr eat/ 0. 7)-0. 2 1 9  × ( Sc ys/ 0. 8) -0. 3 2 3  × ( 0. 9 9 6 1) A ge  
Fe male  
if ≤0. 7 
if > 0. 8 
e G F R = 1 3 0 × ( Scr eat/ 0. 7)-0. 2 1 9  × ( Sc ys/ 0. 8)-0. 7 7 8  × ( 0. 9 9 6 1) A ge  
Fe male  
if > 0. 7 
if ≤0. 8 
e G F R = 1 3 0 × ( Scr eat/ 0. 7)-0. 5 4 4  × ( Sc ys/ 0. 8) -0. 3 2 3  × ( 0. 9 9 6 1) A ge  
Fe male  
if > 0. 7 
if > 0. 8 
e G F R = 1 3 0 × ( Scr eat/ 0. 7)-0. 5 4 4  × ( Sc ys/ 0. 8) -0. 7 7 8  × ( 0. 9 9 6 1) A ge  
Male  
if ≤0. 9 
if ≤0. 8 
e G F R = 1 3 5 × ( Screat/ 0. 9)-0. 1 4 4  × ( Sc ys/ 0. 8) -0. 3 2 3  × ( 0. 9 9 6 1) A ge  
Male  
if ≤0. 9 
if > 0. 8 
e G F R = 1 3 5 × ( Scr eat/ 0. 9)-0. 1 4 4  × ( Sc ys/ 0. 8) -0. 7 7 8  × ( 0. 9 9 6 1) A ge  
Male  
if > 0. 9 
if ≤0. 8 
e G F R = 1 3 5 × ( Scr eat/ 0. 9)-0. 5 4 4  ×  ( Sc ys/ 0. 8) -0. 3 2 3  × ( 0. 9 9 6 1) A ge  
Male  
if > 0. 9 
if > 0. 8  
e G F R = 1 3 5 × ( Scr eat/ 0. 9)-0. 5 4 4  ×  ( Sc ys/ 0. 8)-0. 7 7 8  × ( 0. 9 9 6 1) A ge  
(I n ker et al, 2 0 2 1) 
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 9 9  
1 0. 7. 3.  Ki d ne y F u ncti o n C alc ul ati o n T o ols  
T he s p o ns or has pr o vi de d t he f oll o wi n g res o urces t o i n vesti gati o nal sites w he n re q uire d t o 
calc ulate a ge -s pecific ki d ne y f u ncti o n at Scree ni n g, Baseli ne, a n d p ost-Baseli ne visits. Site 
calc ulati o ns of ki d ne y f u ncti o n ca n be perf or me d ma n uall y , usi n g t he a ge a p pr o priate 
f or m ulae (see Secti o n 1 0. 7. 2 ) a n d ca n use rec o m me n de d o nli ne ki d ne y f u ncti o n calc ulat ors 
t o re d uce t he li keli h o o d of a calc ulati o n err or.  
T he U nite d States Nati o nal Ki d ne y F o u n dati o n O nli ne Calc ulat ors.  
•  A d ults ( 1 8 years a n d a b o ve) - 2 0 2 1 C K D -E PI Creati ni ne O nli ne Calc ulat or (e G F R): 
htt ps:// w w w. ki d ne y. or g/ pr ofessi o nals/ K D O QI/ gfr _calc ulat or   
I n vesti gati o nal sites are res p o nsi ble t o e ns ure t hat t he acc urate a ge-s pecific e q uati o n is 
selecte d a n d t hat t he c orrect u nits are use d f or ser u m creati ni ne ( m g/ d L o nl y), ser u m c ystati n 
C ( m g/ L o nl y), t otal b o d y wei g ht ( k g o nl y), a n d a ge ( years). I n vesti ga t ors are e x pecte d t o (i) 
re vie w a n d c o nfir m c orrect ness of t he ki d ne y f u ncti o n calc ulati o n res ults a n d (ii) e val uate t he 
calc ulate d val ue wit hi n t he c o nte xt of hist orical i nf or mati o n a vaila ble t o t he m i n t he 
partici pa nt’s me dical rec or d. I n vesti gat ors are res p o nsi ble f or t he cli nical o versi g ht of t he 
partici pa nt eli gi bilit y pr ocess, ki d ne y f u ncti o n calc ulati o n, a n d d ose selecti o n a n d 
a dj ust me nts per st u d y pr ot oc ol. I n vesti gat ors are e nc o ura ge d t o direct q uesti o ns or 
u ncertai nties re gar di n g ki d ne y f u ncti o n a n d d osi n g t o t he s p o ns or or s p o ns or’s desi g nee , if 
nee de d.  
1 0. 7. 4.  A d verse E ve nt Gr a di n g f or Ki d ne y S afet y L a b or at or y  A b n or m alities  
A E  gra di n g f or decli ne i n ki d ne y f u ncti o n (ie, e G F R or e Cr Cl) will be acc or di n g t o K DI G O  
criteria  f or a d ult partici pa nts. 
K DI G O criteri a 
gr a de ( G)  
St u d y 
P o p ul ati o n  
G 1  
G 2  
G 3  
G 4  
G 5  
Decre ase d 
Ki d ne y F u ncti o n 
d ue t o eit her 
Ac ute or C hr o nic 
Ki d ne y I nj ur y  
A d ult 
partici pa nts  
e G F R 
( m L/ mi n/ 1. 7 3 m²) 
≥9 0  
≥6 0 t o 8 9  
3 0 t o 5 9  
1 5 t o 2 9  
< 1 5  
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 0 0  
1 0. 8.  A p pe n di x 8 : E C G Fi n di n gs of P ote nti al Cli nic al C o ncer n  
E C G Fi n di n gs T h at M a y  Q u alif y as A Es  
•  Mar ke d si n us b ra d ycar dia (rate < 4 0 b p m) lasti n g mi n utes. 
•  Ne w P R i nter val pr ol o n gati o n > 2 8 0 m s. 
•  Ne w pr ol o n gati o n of Q Tc F t o > 4 8 0 ms (a bs ol ute)  
•  N ew pr ol o n gati o n of Q T c F b y 6 0 ms fr o m baseli ne . 
•  Ne w -o nset atrial fl utter or fi brillati o n, wit h c o ntr olle d ve ntric ular res p o nse rate: ie, 
rate < 1 2 0 b p m . 
•  Ne w -o nset ty pe I sec o n d-d e gree ( We nc ke bac h) A V b l oc k of > 3 0 sec o n ds’ 
d urati o n . 
•  Fre q ue nt P V Cs, tri plets, or s h ort i nter vals ( < 3 0  sec o n ds) of c o nsec uti ve ve ntric ular 
c o m ple xes . 
E C G Fi n di n gs T h at M a y  Q u alif y as S A Es  
•  Q Tc F pr ol o n gati o n > 5 0 0 ms . 
•  A bs ol ute val ue of Q Tc F > 4 5 0 ms A N D Q Tc F c ha n ge fr o m baseli ne > 6 0 ms.  
•  Ne w S T -T c ha n ges s u g gesti ve of m y ocar dial isc he mia . 
•  Ne w -o nset L B B B  ( Q R S c o m ple x  > 1 2 0 ms) . 
•  Ne w -o nset ri g ht b u n dle b ra nc h b l oc k ( Q R S c o m ple x > 1 2 0 ms) . 
•  S y m pt o matic b ra d ycar dia.  
•  As yst ole:  
•  I n a wa ke, s y m pt o m-free partici pa nts  i n si n us r h yt h m, wit h d oc u me nte d 
as yst olic  pa uses  ≥3 sec o n ds or a n y esca pe rate < 4 0 b p m, or wit h a n esca pe 
r h yt h m t hat is bel o w t he A V n o de ;  
•  I n a wa ke, s y m pt o m-free partici pa nts  wit h atrial fi brillati o n  a n d bra d ycar dia 
wit h 1 or m ore as yst olic pa uses of at least 5 sec o n ds or l o n ger ;  
•  Atrial fl utter or fi brillati o n, wit h ra pi d ve ntric ular res p o nse rate: ra pi d = rate 
> 1 2 0  b p m . 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 0 1  
•  S ustai ne d su pra ve ntric ular tac h ycar dia (rate > 1 2 0 b p m) ( “s ustai ne d” = s h ort 
d urati o n wit h rele va nt s y m pt o ms or lasti n g > 1 mi n ute) . 
•  Ve ntric ular r h yt h ms > 3 0 sec o n d d urati o n, i ncl u di n g i di o ve ntric ular r h yt h m ( H R  
< 4 0 b p m), accelerate d i di o ve ntric ular r h yt h m ( H R 4 0  b p m  t o < 1 0 0  b p m ), a n d 
m o n o m or p hic/ p ol y m or p hic ve ntric ular tac h ycar dia ( H R > 1 0 0 b p m [s uc h as 
torsa des de p oi ntes ]). 
•  T y pe II sec o n d-d e gree ( M o bitz  II) A V b l oc k. 
•  C o m plete (t hir d  -de gree) h eart b l oc k. 
E C G Fi n di n gs T h at Q u alif y as S A Es  
•  C ha n ge i n patter n s u g gesti ve of ne w m y ocar dial i nfarcti o n .  
•  S ustai ne d v e ntric ular tac h yarr h yt h mias ( > 3 0 sec o n d d urati o n) . 
•  Sec o n d - or t hir d -de gree A V bl oc k re q uiri n g pace ma ker place me nt . 
•  As yst olic pa uses re q uiri n g pace ma ker place me nt . 
•  Atrial fl utter or fi brillati o n wit h ra pi d ve ntric ular res p o nse re q uiri n g car di o versi o n . 
•  Ve ntric ular fi brillati o n/fl utter. 
•  At t he discreti o n of t he i n vesti gat or, a n y arr h yt h mia classifie d as a n a d verse 
e x perie nce . 
T he maj or e ve nts of p ote ntial cli nical c o ncer n liste d a b o ve are rec o m me n de d as “alerts” or n otificati o ns fr o m 
t he c ore E C G la borat or y  t o t he i n vesti gat or a n d t he s p o ns or st u d y tea m, a n d n ot t o be c o nsi dere d as all -
i ncl usi ve of w hat t o be re p orte d as AEs / S A Es. 
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 0 2  
1 0. 9.  A p pe n di x 9 : I nf usi o n-Rel ate d Re acti o ns  
Partici pa nts  will be m o nit ore d i n  t he cli nic f or 4 h o urs f oll o wi n g I V st u d y dr u g 
a d mi nistrati o n f or I R R . I R R ma y i ncl u de, b ut are n ot li mite d t o: er yt he ma, i n d urati o n, 
ecc h y m osis, pai n, a n d p rurit us.  
If a n I R R occ urs d uri n g st u d y i nter ve nti o n a d mi nistrati o n, t he f oll o wi n g treat me nt 
rec o m me n dati o ns are pr o vi de d a n d ma y be m o difie d per l ocal treat me nt sta n dar ds a n d 
g ui deli nes as a p pr o priate:  
•  Gr a de 1 ( mil d):  I nf usi o n rate m o dificati o n n ot i n dicate d. A d mi nister s y m pt o matic 
treat me nt (e g, a nti hista mi nes, a nti p yretics, a ntie metics) as nee de d. Cl osel y m o nit or 
partici pa nt u ntil res ol uti o n. Pr o p h yla xis wit h di p he n h y dra mi ne 5 0 m g ( or e q ui vale nt) 
a n d/ or aceta mi n o p he n / paraceta m ol 3 2 5 t o 1 0 0 0 m g is rec o m me n de d at least 3 0 mi n utes  
pri or t o f ut ure st u d y i nter ve nti o n i nf usi o ns.  
•  Gr a de 2 ( m o der ate):  Sl o w i nf usi o n rate t o ≤5 0 % of t he ori gi nal i nf usi o n rate a n d treat 
s y m pt o ms wit h a p pr o priate me dical t hera p y, i ncl u di n g b ut n ot li mite d t o a nti hista mi nes, 
a nti p yretics, a n d a nal gesics. I ncrease m o nit ori n g of vital si g ns as me dicall y i n dicate d 
u nti l partici pa nt is dee me d sta ble. Pr o p h yla xis wit h di p he n h y dra mi ne 5 0 m g ( or 
e q ui vale nt) a n d/ or aceta mi n o p he n/ paraceta m ol 3 2 5 t o 1 0 0 0 m g is rec o m me n de d at least 
3 0 mi n utes  pri or t o f ut ure st u d y i nter ve nti o n i nf usi o ns.  
•  Gr a de 3 (se vere):  St o p i nf usi o n a n d i nstit ute a p pr o priate s y m pt o m -directe d t hera p y, 
i ncl u di n g b ut n ot li mite d t o a nti hista mi nes, a nti p yretics, c ortic oster oi ds, br o nc h o dilat ors, 
a n d O 2. I ncrease m o nit ori n g of vital si g ns as me dicall y i n dicate d u ntil partici pa nt is 
dee me d sta ble.  
•  If t he reacti o n has n ot res ol ve d wit hi n 6 h o urs of st u d y dr u g pre parati o n , t he 
re mai n der of t he i nf usi o n will n ot be a d mi nistere d a n d st u d y i nter ve nti o n will be 
per ma ne ntl y disc o nti n ue d . 
•  F oll o wi n g t he c o m pleti o n or ter mi nati o n of a restarte d i nf usi o n d ue t o a n I R R : 
•  A ll partici pa nts m ust be m o nit ore d u ntil res ol uti o n of s y m pt o ms or f or at least 2 
h o urs i n t he a bse nce of a d diti o nal s y m pt o ms.   
•  Pr o p h yla xis wit h di p he n h y dra mi ne 5 0 m g ( or e q ui vale nt) a n d/ or 
aceta mi n o p he n/ paraceta m ol 3 2 5 t o 1 0 0 0 m g is rec o m me n de d at least 3 0 mi n utes  
pri or t o f ut ure st u d y i nter ve nti o n i nf usi o ns.  
•  T he ne xt i nf usi o n s h o ul d i nitiate at a rate of 2 h o urs per d ose, or 2 5 %   of t he rate 
at w hic h t he reacti o n occ urre d.  If n o I R Rs are o bser ve d wit hi n t he first 3 0 
mi n utes, t he i nf usi o n rate ma y i ncrease t o 3 0 -mi n utes -per d ose rate as o utli ne d i n  
Secti o n 6. 1. 1 .  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 0 3  
•  I n cases w here i nf usi o n has starte d b ut ca n n ot be c o m plete d wit h 6 h o urs of st u d y 
dr u g pre parati o n, t he re mai n der of t he i nf usi o n will n ot be a d mi nistere d a n d st u d y 
i nter ve nti o n will be per ma ne ntl y disc o nti n ue d. 
•  If sec o n d occ urre nce of Gra de 3 or greater I R R, per ma ne ntl y disc o nti n ue st u d y 
i nter ve nti o n. 
•  Gr a de 4 (life -t hre ate ni n g): St o p i nf usi o n a n d i m me diatel y i nstit ute a p pr o priate 
s y m pt o m directe d t hera p y a n d s u p p orti ve meas ures as necessar y, i ncl u di n g b ut n ot 
li mite d t o, c ortic oster oi ds, br o nc h o dilat ors, O2/res pirat or y s u p p ort, a n d vas o press ors. 
H os pitalizati o n a n d/ or i nte nsi ve care u nit a d missi o n ma y be i n dicate d.  
•  Per ma ne ntl y disc o nti n ue st u d y i nter ve nti o n.
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 0 4  
1 0. 1 0.  A p pe n di x 1 0 : C o m m o n Ter mi n ol o g y Criteri a F or A d verse E ve nts  
C T C A E Ter ms   
A Es are defi ne d i n A p pe n di x 3 . A n A E is a ter m t hat is a u ni q ue re prese ntati o n of a s pecific 
e ve nt use d f or me dical d oc u me ntati o n a n d scie ntific a nal yses. Eac h C T C A E ter m as a 
Me d D R A L o west Le vel Ter m.  T he latest a vaila ble versi o n of C T C A E will be use d  
(N CI  NI H, 2 0 2 2 ). 
Defi niti o ns  
A brief defi niti o n is pr o vi de d t o clarif y t he mea ni n g of eac h A E ter m.  
Gr a des  
Gra de refers t o t he se verit y of t he A E  a n d are s pecifie d i n A p pe n di x 3 . F urt her details are 
pr o vi de d bel o w.  C T C A E v 6 . 0 gra des f or GI dis or ders fre q ue ntl y o bser ve d i n t he FI H st u d y  
K A N -1 0 1 -0 1 are pr o vi de d i n Ta ble  4 . 
T he C T C A E dis pla ys Gra des 1 t hr o u g h Gra de 5 wit h u ni q ue cli nical descri pti o ns of se verit y 
f or eac h A E base d o n t his ge neral g ui deli ne: 
•  Gr a de  1:  Mil d; as y m pt o matic or mil d s y m pt o ms; cli nical or dia g n ostic o bser vati o ns 
o nl y; i nter ve nti o n n ot i n dicate d  
•  Gr a de 2:  M o derate; mi ni mal, l ocal or n o ni n vasi ve i nter ve nti o n i n dicate d; li miti n g 
a ge a p pr o priate i nstr u me ntal A D L *  
•  Gr a de 3:  Se vere or me dicall y si g nifica nt b ut n ot i m me diatel y life -t hreate ni n g; 
h os pitalizati o n or pr ol o n gati o n of h os pitalizati o n i n dicate d; disa bli n g ; li miti n g 
selfcare A D L* *  
•  Gr a de 4:  Life -t hreate ni n g c o nse q ue nces; ur ge nt i nter ve nti o n i n dicate d 
•  Gr a de 5:  Deat h relate d t o A E  
A se mi -c ol o n i n dicates ‘ or’ wit hi n t he descri pti o n of t he gra de.  
A si n gle das h ( -) i n dicates a gra de is n ot a vaila ble. 
N ot all gra des are a p pr o priate f or all A Es. T heref ore, s o me A Es are liste d wit h fe wer t ha n 5 
o pti o ns f or Gra de selecti o n. Gra de 5 ( Deat h) is n ot a p pr o priate f or s o me A Es a n d is t heref ore 
n ot a n o pi ni o n.  
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 0 5  
T a ble  4 . 
C T C A E v 6 . 0 or Hi g her Gr a des f or GI Dis or ders O bser ve d i n K A N -1 0 1 -0 1 
( FI H St u d y) 
C T C A E Ter m  
Gr a de 1  
Gr a de 2  
Gr a de 3  
Gr a de 4  
Gr a de 5  
N a use a  
L oss of a p petite 
wit h o ut 
alterati o n i n 
eati n g ha bits 
Oral i nta ke decrease d 
wit h o ut si g nifica nt 
wei g ht l oss, 
de h y drati o n or 
mal n utriti o n  
I na de q uate oral cal oric or 
fl ui d i nta ke; t u be fee di n g, 
T P N, or h os pitalizati o n 
i n dicate d 
 - 
 - 
A b d o mi n al p ai n  
 
Mil d pai n  
M o derate pai n, 
li miti n g i nstr u me ntal 
A D L  
Se vere pai n; li miti n g 
selfcare A D L 
- 
- 
V o miti n g  
I nter ve nti o n n ot 
i n dicate d 
O ut patie nt I V 
h y drati o n; me dical 
i nter ve nti o n i n dicate d 
T u be fee di n g, T P N, or 
h os pitalizati o n i n dicate d  
Life -t hreate ni n g 
c o nse q ue nces  
Deat h  
C o nsti p ati o n  
Occasi o nal or 
i nter mitte nt 
s y m pt o ms; 
occasi o nal use of 
st o ol s ofte ners, 
la xati ves, dietar y 
m o dificati o n, or 
e ne ma 
Persiste nt s y m pt o ms 
wit h re g ular use of 
la xati ves or e ne mas; 
li miti n g i nstr u me ntal 
A D L  
O bsti pati o n wit h ma n ual 
e vac uati o n i n dicate d; 
li miti n g selfcare A D L 
Life -t hreate ni n g 
c o nse q ue nces; 
ur ge nt 
i nter ve nti o n 
i n dicate d 
Deat h  
Di arr he a  
I ncrease of < 4 
st o ols per da y 
o ver baseli ne; 
mil d i ncrease i n 
ost o m y o ut p ut 
c o m pare d t o 
baseli ne  
I ncrease of 4 - 6 st o ols 
per da y o ver baseli ne; 
m o derate i ncrease i n 
ost o m y o ut p ut 
c o m pare d t o baseli ne; 
li miti n g i nstr u me ntal 
A D L  
I ncrease of > = 7 st o ols per 
da y o ver baseli ne; 
h os pitalizati o n i n dicate d; 
se vere i ncrease i n ost o m y 
o ut p ut c o m pare d t o 
baseli ne; li miti n g selfcare 
A D L  
Life -t hreate ni n g 
c o nse q ue nces; 
ur ge nt 
i nter ve nti o n 
i n dicate d 
Deat h  
D ys pe psi a  
Mil d s y m pt o ms; 
i nter ve nti o n n ot 
i n dicate d 
M o derate s y m pt o ms; 
me dical i nter ve nti o n 
i n dicate d 
Se vere s y m pt o ms; o perati ve 
i nter ve nti o n i n dicate d 
 - 
 - 
Fl at ule nce  
Mil d s y m pt o ms; 
i nter ve nti o n n ot 
i n dicate d 
M o derate s y m pt o ms; 
ps yc h os ocial se q uelae 
- 
- 
- 
C T C A E:  C o m m o n Ter mi n ol o g y Criteria f or A d verse E ve nts ; FI H: First- i n- H u ma n, A D L: Acti vities of dail y 
li vi n g. 
 
Acti vities of D ail y Li vi n g  
*  I nstr u me ntal A D L refer t o pre pari n g meals, s h o p pi n g f or gr oceries or cl ot hes, usi n g t he 
tele p h o ne, ma na gi n g m o ne y, etc. 
* * Selfcare A D L refer t o bat hi n g, dressi n g a n d u n dressi n g, fee di n g self, usi n g t he t oilet, 
ta ki n g me dicati o ns, a n d n ot be d ri d de n.  
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 0 6  
1 0. 1 1.  A p pe n di x 1 1: A S A P h ysic al St at us Cl assific ati o n S yste m  
A S A P h ysic al St at us  
Cl assific ati o n  
Defi niti o n  
A d ult E x a m ples, i ncl u di n g, b ut n ot 
Li mite d t o:  
A S A I  
A n or mal healt h y patie nt  
Healt h y, n o n -s m o ki n g, n o or mi ni mal 
alc o h ol use 
A S A II  
A patie nt wit h mil d s yste mic 
disease  
Mil d diseases o nl y wit h o ut s u bsta nti ve 
f u ncti o nal li mitati o ns. C urre nt s m o ker, s ocial 
alc o h ol dri n ker, pre g na nc y, o besit y 
( 3 0 < B MI < 4 0), well-c o ntr olle d D M/ H T N, 
mil d l u n g disease  
A S A III  
A patie nt wit h se vere s yste mic 
disease  
S u bsta nti ve f u ncti o nal li mitati o ns; O ne or 
m ore m o derate t o se vere diseases. P o orl y 
c o ntr olle d D M or H T N, C O P D, m or bi d 
o besit y ( B MI ≥4 0), acti ve he patitis, alc o h ol 
de pe n de nce or a b use, i m pla nte d pace ma ker, 
m o derate re d ucti o n of ejecti o n fracti o n, 
E S R D u n de r g oi n g re g ularl y sc he d ule d 
dial ysis, hist or y ( > 3 m o nt hs) of MI, C V A, 
TI A, or C A D/ste nts  
A S A I V  
A patie nt wit h se vere s yste mic 
disease t hat is a c o nsta nt t hreat t o 
life 
Rece nt ( < 3 m o nt hs) MI, C V A, TI A or 
C A D/ste nts, o n g oi n g car diac isc he mia or 
se vere val ve d ysf u ncti o n, se vere re d ucti o n of 
ejecti o n fracti o n, s h oc k, se psis, DI C, A R D or 
E S R D n ot u n der g oi n g re g ularl y sc he d ule d 
dial ysis  
A S A V  
A m ori b u n d patie nt w h o is n ot 
e x pecte d t o s ur vi ve wit h o ut t he 
o perati o n  
R u pt ure d a b d o mi nal/t h oracic a ne ur ys m, 
massi ve tra u ma, i ntracra nial blee d wit h mass 
effect, isc he mic b o wel i n t he face of 
si g nifica nt car diac pat h ol o g y or m ulti ple 
or ga ns/s yste m d ysf u ncti o n  
A S A VI  
A declare d brai n -dea d patie nt 
w h ose or ga ns are bei n g re m o ve d 
f or d o n or p ur p oses 
 
A R D -Ac ute Res pirat or y Distress ; A S A -A merica n S ociet y of A nest hesi ol o gists; B MI -B o d y Mass I n de x; 
C A D -C or o nar y Arter y Disease; C O P D -C hr o nic O bstr ucti ve P ul m o nar y Disease ; C V A -Cere br o vasc ular 
Acci de nt ; DI C -Disse mi nate d I ntra vasc ular C oa g ulati o n; D M -Dia betes Mellit us; E S R D -E n d -Sta ge Re nal 
Disease; H T N -H y perte nsi o n ; MI -M y ocar dial I nfarcti o n ; TI A -Tra nsie nt Isc he mic  Attac k  
A merica n S ociet y of A nest hesi ol o gists. ( 2 0 2 0)  
 
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 0 7  
1 0. 1 2.  A p pe n di x 1 2: A b bre vi ati o ns  
T he f oll o wi n g is a list of a b bre viati o ns t hat ma y be use d i n t he pr ot oc ol.   
A b bre vi ati o n  
Ter m  
A bs  
abs ol ute  
A D A  
anti -dr u g a nti b o dies  
A D L  
acti vity/acti vit ies of dail y li vi n g 
A E  
a d verse e ve nt  
A KI  
ac ute ki d ne y i nj ur y  
A L P  
al kali ne p h os p hatase 
A L T  
ala ni ne a mi n otra nsferase  
A N C  
a bs ol ute ne utr o p hil c o u nt  
A N C O V A  
anal ysis of c ovaria nce  
A N O V A  
a nal ysis of c o varia nce  
a PT T  
acti vate d partial t hr o m b o plasti n ti me  
A R D  
Ac ute res pirat or y distress  
A S A  
A merica n S ociet y of A nest h esi ol o gists  
A S T  
as partate a mi n otra nsferase  
A U C  
area u n der t he c ur ve  
A U C i nf 
area u n der t he plas ma -c o nce ntrati o n  ti me c ur ve fr o m ti me 0  e xtra p olate d t o i nfi nite 
ti me 
A U C last 
area u n der t he plas ma c o nce ntrati o n -ti me pr ofile fr o m ti me 0 t o t he ti me of t he last 
q ua ntifia ble c o nce ntrati o n ( Clast) 
A V  
atri o ve ntric ular 
A x M P  
a u xiliar y me dici nal pr o d uct  
-h C G  
-h u ma n c h ori o nic g o na d otr o pi n  
B L  
baseli ne  
B MI  
B o d y mass i n de x  
B P  
bl o o d press ure  
b p m  
beats per mi n ute  
C D S D  
Celiac Disease S y m pt o m Diar y  
C A D  
c or o nar y arter y disease  
Ce D  
celiac disease 
C F R  
C o de of Fe deral Re g ulati o ns  
CI  
co nfi de nce i nter val  
CI O M S  
C o u ncil f or I nter nati o nal Or ga nizati o ns of Me dical Scie nces  
C K  
creati ne ki nase 
C K D -E PI  
c hr o nic ki d ne y disease e pi de mi ol o g y  
C ma x   
m a xi m u m plas ma  c o nce ntrati o n  
C O 2 
car b o n di o xi de ( bicar b o nate)  
C O P D  
chr o nic o bstr ucti ve p ul m o nar y disease  
C O VI D -1 9  
c or o na vir us disease 2 0 1 9  
C last 
last q ua ntifia ble c o nce ntrati o n  
C M  
c o nc o mita nt me dicati o ns  
C R F  
case re p ort f or m  
C R O  
c o ntract researc h or ga nizati o n  
C S R  
Cli nical St u d y Re p ort  
C T  
cli nical trial  
C T C A E  
C o m m o n Ter mi n ol o g y Criteria f or A d verse E ve nts  
C TI S  
Cli nical Trial I nf or mati o n S yste m  
C V  
C ar di o vasc ular ; 
C oefficie nt of variati o n  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 0 8  
A b bre vi ati o n  
Ter m  
C V A  
C ere br o vasc ular attac k  
D  
da y  
D C T  
data c ollecti o n t o ol  
D G P  
dea mi date d glia di n pe pti de(s)  
DI C  
Disse mi nate d I ntra vasc ular C oa g ulati o n;  
DI LI  
dr u g -i n d uce d li ver i nj ur y 
D M  
Dia betes mellit us  
D N A  
de o x yri b o n ucleic aci d  
D S M B  
Data Safet y M o nit ori n g B oar d  
D U  
dis pe nsa ble u nit  
E A E  
e x peri me ntal a ut oi m m u ne e n ce p hal o m yelitis  
E C  
et hics c o m mittee  
E C C  
e mer ge nc y c o ntact car d  
E C G  
electr ocar di o gra m or electr ocar di o gra p h y  
e Cr Cl 
esti mate d creati ni ne cleara nce  
e C R F 
electr o nic case re p ort f or m  
E D B  
e x p os ure d uri n g breastfee di n g  
E D P  
e x p os ure d uri n g pre g na nc y  
E F D  
e m br y o nic fetal de vel o p me nt  
E G D  
es o p ha g o gastr o d u o de n osc o p y  
e G F R 
esti mate d gl o mer ular filtrati o n rate  
e S A E 
electr o nic seri o us a d verse e ve nt 
E S R D  
E n d -sta ge re nal disease 
E T  
earl y ter mi nati o n 
et al 
an d ot hers  
E U  
E ur o pea n U n i o n 
E u dra C T  
E ur o pea n U ni o n Dr u g Re g ulati n g A ut h orities Cli nical Trials ( E ur o pea n Cli nical Trials 
Data base)  
F A S  
f ull a nal ysis set 
FI H  
F irst-i n-h u ma n  
F S H  
f ollicle-sti m ulati n g h or m o ne 
F U  
f oll o w-u p  
G C  
g l ute n c halle n ge 
G C P  
G o o d Cli nical Practice  
G F D  
g l ute n-free diet 
G G T  
ga m ma -gl uta m yl tra nsferase  
GI  
gastr oi ntesti nal  
G M  
ge o metric mea n  
G P  
glia di n pe pti de  
H Bc A b  
he patitis B c ore a nti b o d y 
H Bs A b  
he patitis B s urface a nti b o d y  
H Bs A g  
he patitis B s urface a nti ge n  
H B V  
h e patitis B vir us  
H C V  
he patitis C vir us  
H C V A b  
he patitis C vir us a nti b o d y  
HI V  
h u ma n i m m u n o deficie nc y vir us  
H L A  
h u ma n le u k oc yte a nti ge n  
H L A -D Q 2. 5  
h u ma n le u k oc yte a nti ge n l oci e nc o de d b y  H L A -D Q A 1 * 0 5 a n d H L A -D Q B 1 * 0 2 
( h o m oz y g otes or heter oz y g otes) ge n ot y pe 
H L A -D Q 8  
h u ma n le u k oc yte a nti ge n ser ot y pe wit h t he HL A -D Q ser ot y pe gr o u p  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 0 9  
A b bre vi ati o n  
Ter m  
H L A -D Q A 1 a n d 
H L A -D Q B 1  
h u ma n le u k oc yte a nti ge n l oci  
H R  
heart rate  
H R T  
h or m o ne re place me nt t hera p y  
H T N  
h y perte nsi o n  
I A 
interi m a nal ysis  
I B 
I n vesti gat or’s Br oc h ure 
I B S 
Irrita ble B o wel S y n dr o me 
I C D 
Inf or me d C o nse nt D oc u me nt  
I C H 
I nter nati o nal C o u ncil f or Har m o nisati o n of Tec h nical Re q uire me nts f or 
P har mace uticals f or H u ma n Use  
I D 
Ide ntificati o n  
I E L 
i ntrae pit helial l y m p h oc ytes 
I g A 
i m m u n o gl o b uli n A 
I g G 
i m m u n o gl o b uli n G 
I L-2  
i nterle u ki n-2  
I M P 
i n vesti gati o nal me dici nal pr o d uct 
I N D 
In vesti gati o nal N e w Dr u g  
I N R 
i nter nati o nal n or malize d rati o 
I P A L 
I n vesti gati o nal Pr o d uct Acc o u nta bilit y L o g  
I P M 
In vesti gati o nal pr o d uct ma n ual  
I R B 
Instit uti o nal R e vie w B oar d  
I R R 
i nf usi o n-relate d reacti o n 
I R T 
I nteracti ve Res p o nse Tec h n ol o g y 
I V 
intra ve n o us (l y) 
K DI G O  
Ki d ne y Disease: I m pr o vi n g Gl o bal O utc o mes  
K el 
eli mi nati o n rate c o nsta nt 
L B B B  
left b u n dle bra nc h bl oc k 
L F T  
li ver f u ncti o n test 
L S M  
least-s q uares mea n  
M A D  
m ulti ple asce n di n g d ose  
Me d D R A  
Me dical Dicti o nar y f or Re g ulat or y Acti vities  
M H C  
maj or hist oc o m pati bilit y c o m ple x  
MI  
M y ocar dial i nfarcti o n  
M QI  
me dicall y q ualifie d i n di vi d ual  
M T D  
ma xi m u m t olerate d d ose  
N A  
N ot A p plica ble  
N CI  
Nati o nal Ca ncer I nstit ute  
NI M P  
n o ni n vesti gati o nal me dici nal pr o d uct  
N O A E L  
n o o bser ve d a d verse effect le vel  
n  
n u m ber  
O 2  
diat o mic o x y ge n  
O T C  
o ver t he c o u nter  
P B O  
p lace b o 
P GI C  
Patie nt Gl o bal I m pressi o n of C ha n ge  
P GI S  
Patie nt Gl o bal I m pressi o n of Se verit y  
PI  
Pri mar y I n vesti gat or  
P K  
p har mac o ki netic(s)  
P O  
b y m o ut h ; oral (l y) 
P P  
per pr ot oc ol  
P P S  
per pr ot oc ol set  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 1 0  
A b bre vi ati o n  
Ter m  
P R  
p ulse rate  
P R O  
patie nt re p orte d o utc o mes  
P S S A  
Pfizer S A E s u b missi o n assista nt  
P T  
pr ot hr o m bi n ti me  
P V C  
pre mat ure ve ntric ular c o ntracti o ns  
Q Tc  
c orrecte d Q T i nter val  
Q Tc F  
Q Tc c orrecte d usi n g Fri dericia’s f or m ula  
q ual  
q ualitati ve  
R B C  
re d bl o o d cell 
R N A  
ri b o n ucleic aci d 
R SI  
refere nce safet y i nf or mati o n 
S A D  
si n gle asce n di n g d ose 
S A E  
seri o us a d verse e ve nt 
S A P  
S tatistical A nal ysis Pla n  
S A R S -C o V -2  
se vere ac ute res pirat or y s y n dr o me c or o na vir us 2 
Scr.  
scree ni n g 
Scr eat 
ser u m creati ni ne 
Sc ys  
ser u m c ystati n C 
S o A  
sc he d ule of acti vities 
S O C  
sta n dar d of care 
S O P  
sta n dar d o perati n g pr oce d ure 
S R S D  
Si n gle Refere nce Safet y D oc u me nt  
S U S A R  
S us pecte d U ne x pecte d Seri o us A d verse Reacti o ns  
t½   
ter mi nal p hase half-life 
T B D  
t o be deter mi ne d 
T bili  
t otal bilir u bi n 
T E A E  
treat me nt-e mer ge nt a d verse e ve nts  
TI A  
T ra nsie nt isc he mic attac k 
T ma x  
ti me t o reac h Cma x  
T P N  
t otal pare nteral n utriti o n 
t T G 
tra ns gl uta mi nase 
U L N  
u p per li mit of n or mal  
U S  
U nite d States  
U TI  
uri nar y tract i nfecti o n  
V  
visit  
V h: C d  
vill o us hei g ht:cr y pt de pt h rati o  
W B C  
w hite bl o o d cell  
W O C B P  
w o ma n/ w o me n of c hil d beari n g p ote ntial  
 
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 1 1  
1 1.  R E F E R E N C E S  
A del ma n D C, M urra y J, W u T T , et al. Meas uri n g c ha n ge i n s mall i ntesti nal hist ol o g y i n 
patie nts wit h celiac disease. T he A merica n J o ur nal of Gastr oe nter ol o g y. 2 0 1 8.  1 1 3: 3 3 9 -4 7.  
A merica n S ocie nt y of A nest hesi ol o gists. State me nt o n A S A P h ysical Stat us Classificati o n 
S yste m.  2 0 2 0.  
Da ves o n AJ M, Ee H C, A n dre ws J M, et al. E pit o pe -S pecific I m m u n ot hera p y Tar geti n g C D 4 -
P ositi ve T Cells i n Celiac Disease: Safet y, P har mac o ki netics, a n d Effects o n I ntesti nal 
Hist ol o g y a n d Plas ma C yt o ki nes wit h Escalati n g D ose Re gi me ns of Ne x va x 2 i n a 
Ra n d o mi ze d, D o u ble -Bli n d, Place b o -C o ntr olle d P hase 1 St u d y. E Bi o Me dici ne. 2 0 1 7; 2 6: 7 8 -
9 0.  
Gree n P H R, Sta vr o p o ul os S N, Pa na gi S G, et al. C haracteristics of a d ult celiac disease i n t he 
U S A: res ults of a nati o nal s ur ve y. T he A merica n J o ur nal of Gastr oe nter ol o g y. 
2 0 0 1; 9 6( 1): 1 2 6 -3 1.  
Gree n P H R, Ja bri B. Celiac Disease. A n n ual Re vie w of Me dici ne. 2 0 0 6; 5 7( 1): 2 0 7 -2 1.  
Half da nars o n T R, Litz o w M R, M urra y J A. He mat ol o gic ma nifestati o ns of celiac disease. 
Bl o o d. 2 0 0 7; 1 0 9( 2): 4 1 2 -2 1.  
I n ker L A, E nea n ya N D, C ores h J, et al. Ne w Creati ni ne- a n d C ystati n C -Base d E q uati o ns t o 
Esti mate G F R wit h o ut Race. N E n gl J Me d. 2 0 2 1; 3 8 5( 1 9): 1 7 3 7 -4 9.  
M urra y J A, Wassaf D, D u n n K, et al. Safet y a n d t olera bilit y of K A N -1 0 1, a li ver -tar gete d 
i m m u ne t olera nce t hera p y, i n patie nts wit h c oeliac disease ( A Ce D): a p hase 1 trial. La ncet 
Gastr oe nter ol He pat ol. 2 0 2 3; 8( 8): 7 3 5 -4 7.  
N CI  NI H. C o m m o n Ter mi n ol o g y Criteria f or A d verse E ve nts. Versi o n 6. 0. . 2 0 2 2. A vaila ble 
fr o m: htt ps://cte p.ca ncer. g o v/ pr ot oc ol de vel o p me nt/electr o nic _a p plicati o ns/ctc. ht m . 
Accesse d: 2 4 A u g ust 2 0 2 2.  
R u bi o -Ta pia A, Hill I D, Kell y C P, et al. A C G Cli nical G ui deli nes: Dia g n osis a n d 
Ma na ge me nt of Celiac Disease. A merica n J o ur nal of Gastr oe nter ol o g y. 2 0 1 3; 1 0 8( 5): 6 5 6 -7 6.  
See J A, Ka u ki ne n K, Ma k haria G K, et al. Practical i nsi g hts i nt o gl ute n -free diets. Nat ure 
Re vie ws Gastr oe nter ol o g y a n d He pat ol o g y. 2 0 1 5; 1 2( 1 0): 5 8 0 -9 1.  
Si n g h P, Ar ora A, Stra n d T A, et al. Gl o bal Pre vale nce of Celiac Disease: S yste matic Re vie w 
a n d Meta -a nal ysis. Cli nical Gastr oe nter ol o g y a n d He pat ol o g y. 2 0 1 8; 1 6( 6): 8 2 3 -3 6.e 2.  
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)

K A N -1 0 1  
Pr ot oc ol K A N -1 0 1 -0 3  
Fi nal Pr ot oc ol  A me n d me nt  0 1 , 2 0  Marc h 2 0 2 4   
 
C O N FI D E N TI A L  
C T 0 2 -G S O P Cli nical Pr ot oc ol Te m plate P hase 1 2 3 4 ( 1 4  A pril 2 0 2 3 ) 
Pa ge 1 1 2  
S olli d L M, Mar k usse n G, E k J, et al. E vi de nce f or a pri mar y ass ociati o n of celiac disease t o a 
partic ular H L A -D Q al p ha/ beta heter o di mer. J o ur nal of E x peri me ntal Me dici ne. 
1 9 8 9; 1 6 9( 1): 3 4 5 -5 0.  
S olli d L M, Qia o S -W, A n ders o n R P, et al. N o me nclat ure a n d listi n g of celiac disease 
rele va nt gl ute n T-cell e pit o pes restricte d b y H L A -D Q m olec ules. I m m u n o ge netics. 
2 0 1 2; 6 4( 6): 4 5 5 -6 0.  
S olli d L M, Ja bri B. Tri g gers a n d dri vers of a ut oi m m u nit y: less o ns fr o m c oeliac disease. 
Nat ure Re vie ws I m m u n ol o g y. 2 0 1 3; 1 3( 4): 2 9 4 -3 0 2.  
T h o ms o n A W, K n olle P A. A nti ge n -prese nti n g cell f u ncti o n i n t he t oler o ge nic li ver 
e n vir o n me nt. Nat ure Re vie ws I m m u n ol o g y. 2 0 1 0; 1 0( 1 1): 7 5 3 -6 6.  
Tr uitt K E, Da ves o n AJ M, Ee H C, et al. Ra n d o mise d cli nical trial: a place b o -c o ntr olle d st u d y 
of s u bc uta ne o us or i ntra der mal N E X V A X 2, a n i n vesti gati o nal i m m u n o m o d ulat or y pe pti de 
t hera p y f or c oeliac disease. Ali me ntar y p har mac ol o g y a n d t hera pe utics. 2 0 1 9; 5 0( 5): 5 4 7-5 5.  
 
0 9 0 1 7 7 e 1 a 0 4 1 c 2 d 5\ A p pr o v e d\ A p pr o v e d O n: 2 2- M ar- 2 0 2 4 1 3: 5 2 ( G M T)