Clinical trial NCT04611789
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2020-11-02; Completion date: 2021-02-10
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the safety and tolerability of LY3832479 when it is given by injection just under the skin to healthy participants. Blood tests will be done to check how much LY3832479 is in the bloodstream and how long the body takes to eliminate it. Participation could last up to 16 weeks and may include up to six visits to the study center, with a one-week overnight stay.

Detailed description:

Arms: arm 1: Participants received single subcutaneous dose of 350 milligrams (mg) and 1000 mg LY3832479. arm 2: Participants received single subcutaneous dose of Placebo.
Interventions: intervention 1: LY3832479 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered subcutaneously intervention 2: Administered subcutaneously

Protocol documents:
Prot_000.pdf: 
Pr ot oc ol : J 2 Z- M C- P G A B
A Ra n d o mize d, Place b o- C o ntr olle d, Partici pa nt- a n d I n vesti gat or- Bli n d, P hase 1 St u d y t o 
E val uate t he P har mac o ki netics, Safet y, a n d T olera bilit y of L Y 3 8 3 2 4 7 9 A d mi nistere d 
S u bc uta ne o usl y t o Healt h y Partici pa nts
N C T 0 4 6 1 1 7 8 9 
A p pr o val Date: 3 0- Se p- 2 0 2 0


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Title P a ge
C o nfi d e nti al I nf or m ati o n
T h e i nf or m ati o n c o nt ai n e d i n t hi s d o c u m e nt i s c o nfi d e nti al a n d i s i nt e n d e d f or t h e u s e of cli ni c al i n v e sti g at or s. It i s t h e pr o p ert y of 
Eli Lill y a n d C o m p a n y or it s s u b si di ari e s a n d s h o ul d n ot b e c o pi e d b y or di stri b ut e d t o p er s o n s n ot i n v ol v e d i n t h e cli ni c al 
i n v e sti g ati o n of L Y 3 8 3 2 4 7 9 , u nl e s s s u c h p er s o n s ar e b o u n d b y a c o nfi d e nti alit y a gr e e m e nt wit h Eli Lill y a n d C o m p a n y or it s 
s u b si di ari e s . 
N ot e t o R e g ul at or y A ut h oriti e s: T hi s d o c u m e nt m a y c o nt ai n pr ot e ct e d p er s o n al d at a a n d/ or c o m m er ci all y c o nfi d e nti al i nf or m ati o n 
e x e m pt fr o m p u bli c di s cl o s ur e. Eli Lill y a n d C o m p a n y r e q u e st s c o n s ult ati o n r e g ar di n g r el e a s e/r e d a cti o n pri or t o a n y p u bli c r e l e a s e.
I n t h e U nit e d St at e s, t hi s d o c u m e nt i s s u bj e ct t o Fr e e d o m of I nf or m ati o n A ct ( F OI A) E x e m pti o n 4 a n d m a y n ot b e r e pr o d u c e d or 
ot h er wi s e di s s e mi n at e d wit h o ut t h e writt e n a p pr o v al of Eli Lill y a n d C o m p a n y or it s s u b si di ari e s .
Pr ot oc ol Title: A Ra n d o mi ze d, Pl ace b o -C o n tr olle d, Participa nt - a n d I n vesti gat or -Bli n d, P hase 1 
St u d y  t o E valuate t he P har mac o ki net ics, Safety,  a n d T olera bilit y of L Y 3 8 3 2 4 7 9
A d mi nistere d S u bc uta ne o usl y t o Healt h y Partici pa nts
Pr ot oc ol N u m ber: J 2Z- M C -P G A B
A me n d me nt N u m ber: T his is t he i nit ial pr ot oc ol.
C o m p o u n d : L Y 3 8 3 2 4 7 9
St u d y P h ase: 1
S h ort Title: A Ra n d o mize d, Pl ace b o -C o n tr olle d, P hase 1 St u d y  t o E valuate t he 
P har mac o ki net ics, Safety,  a n d T olera bilit y of L Y 3 8 3 2 4 7 9 A d mi nistere d 
S u bc uta ne o usl y  t o H e alt h y P artici pa nts
S p o ns or N a me: El i Lill y  a n d C o mpa n y
Le g al Re gistere d A d dress: I n dia na p olis, I n dia na U S A 4 6 2 8 5
Re g ul at or y A ge nc y I de ntifier N u m ber:
I N D: 1 5 0 7 0 7
A p pr o v al D ate: Pr ot oc ol El ectr o nicall y Si g ne d a n d A p pr o ve d b y Lill y o n date pr o vi de d bel o w.
A p pr o v al D at e: 3 0- S e p- 2 0 2 0 G M T


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Medical Monitor Name and Contact Information will be provided separately.


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T a ble of C o nte nts
1.
Pr ot oc ol S u m m ar y ......................................................................................................6
1. 1.
S y n o psis .......................................................................................................................6
1. 2.
Sc he ma .........................................................................................................................7
1. 3.
Sc he d ule of Act i vities ( S o A) ........................................................................................8
2.
I ntr o d ucti o n ..............................................................................................................1 4
2. 1.
St u d y  Ratio nale ..........................................................................................................1 4
2. 2.
Bac k gr o u n d ................................................................................................................1 4
2. 3.
Be nefit/ Ris k Assess me nt ............................................................................................1 5
3.
O bjecti ves a n d E n d p oi nts .........................................................................................1 7
4.
St u d y Desi g n .............................................................................................................1 8
4. 1.
O verall Desi g n ............................................................................................................1 8
4. 1. 1.
Scree ni n g a n d E nr oll me nt ...........................................................................................1 8
4. 1. 2.
I n patient  Sta y..............................................................................................................1 8
4. 1. 3.
O ut pati e nt F oll o w-U p ................................................................................................. 1 8
4. 2.
S ci e nt ific Rati o nale f or St u d y Desi g n.........................................................................1 9
4. 3.
J ustificati o n f or D ose..................................................................................................1 9
4. 4.
E n d of St u d y  Defi niti on ..............................................................................................1 9
5.
St u d y P o p ul ati o n ......................................................................................................2 0
5. 1.
I ncl usi on Cri t eria ........................................................................................................2 0
5. 2.
E xcl usi o n Cri t eria .......................................................................................................2 0
5. 3.
Lifest yle C o nsi derat i ons .............................................................................................2 3
5. 3. 1.
Meals a n d Dietar y  Restrict i ons ...................................................................................2 3
5. 3. 2.
Caffei ne, Alc o h o l, a n d T o bacc o..................................................................................2 3
5. 3. 3.
Act i vity ......................................................................................................................2 3
5. 4.
Scree n Fail ures ...........................................................................................................2 3
6.
St u d y I nt er ve nti o n ....................................................................................................2 5
6. 1.
St u d y  I nter ve nti ons A d mi nistere d ...............................................................................2 5
6. 1. 1.
I njecti on V ol u mes a n d F or m ulat i on C o nce ntrati o ns ....................................................2 7
6. 1. 2.
I n t he E ve nt of a Retr os pecti ve P ositi ve Sterility Fi n di n g fr o m 
Pre pare d St u d y ...........................................................................................................2 7
6. 2.
Pre parati o n/ Ha n dl i n g/ St ora ge/ Acc o u nta bility .............................................................2 7
6. 3.
Meas ures t o Mi ni mize Bias: Ra n d o mizat i on a n d Bli n di n g ..........................................2 7
6. 4.
St u d y  I nter ve nti on C o m plia nce ...................................................................................2 8
6. 5.
C o nc o mita nt T hera p y ................................................................................................. 2 8
6. 6.
D ose M o dificat i on ......................................................................................................2 9
6. 6. 1.
D ose -Escal at i on Cri t eria .............................................................................................2 9
6. 6. 2.
Access t o Data d uri n g t he St u d y .................................................................................2 9
6. 6. 3.
T e m p orar y  St o p pi n g Crit eria ......................................................................................2 9
6. 7.
I nter ve nti o n After t he E n d of t he St u d y ......................................................................2 9
7.  
Disc o nti n u ati o n of St u d y I nter ve nti o n a n d P artici p a nt 
Disc o nti n u ati o n/ Wit h dr a w al ....................................................................................3 0
7. 1.
Di sc o nti n uatio n of  St u d y I nter ve nti on ........................................................................3 0


C O N FI D E N TI A L
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7. 2.
P arti cipa nt Disc o nti n uati o n/ Wit h dra wal fr o m t he St u d y .............................................3 0
7. 2. 1.
Di sc o nti n uatio n of  I na d verte ntl y Enr olle d Partici pa nts ...............................................3 0
7. 3.
L ost t o F oll o w - u p .......................................................................................................3 1
8.
St u d y Assess me nts a n d Pr oce d ures .........................................................................3 2
8. 1.
Efficac y Assess me nts ................................................................................................. 3 2
8. 2.
S af et y Assess me nts ....................................................................................................3 2
8. 2. 1.
P h ysical E xa mi nat i ons ................................................................................................3 2
8. 2. 2.
Vi t al Sig ns.................................................................................................................. 3 2
8. 2. 3.
Electr ocar di o gra ms .....................................................................................................3 2
8. 2. 4.
Cli nical Safet y  La b orat or y Assess me nts .....................................................................3 3
8. 2. 5.
He pati c M o nit orin g .....................................................................................................3 3
8. 2. 6.
I njecti on Si te Reactio n Assess me nt .............................................................................3 5
8. 3.
A d verse E ve nts a n d Seri o us A d verse E ve nts ..............................................................3 5
8. 3. 1.
Ti me Peri o d a n d Fre q ue nc y  for C ollect i n g A E a n d S A E 
I nf or mat i on .................................................................................................................3 6
8. 3. 2.
Met h o d of Detecti n g A Es a n d S A Es ...........................................................................3 6
8. 3. 3.
F o ll ow- u p of  A Es a n d S A Es.......................................................................................3 6
8. 3. 4.
Re g ulat or y  Re p orti n g Re q uire me nts f or S A Es............................................................3 6
8. 3. 5.
Pre g na nc y ...................................................................................................................3 7
8. 3. 6.
H y perse nsi tivi t y R e a ctio ns .........................................................................................3 7
8. 3. 7.
S A R S -C o V -2 I nfect i on ...............................................................................................3 7
8. 3. 8.
Pr o d uct C o m plai nt s ....................................................................................................3 7
8. 4.
Treat me nt of O ver d ose ...............................................................................................3 8
8. 5.
P har mac o ki net ics........................................................................................................3 8
8. 5. 1.
Bi oa nal y tic al ..............................................................................................................3 9
8. 6.
P har mac o d y na mics .....................................................................................................3 9
8. 7.
Ge net ics .....................................................................................................................3 9
8. 8.
Bi o m ar kers .................................................................................................................3 9
8. 9.
I mm u n o ge nicit y Assess me nts .....................................................................................3 9
8. 1 0.
Heal t h Ec o n o mics.......................................................................................................4 0
9.
St atistic al C o nsi der ati o ns .........................................................................................4 1
9. 1.
Stati stical H y p ot heses................................................................................................. 4 1
9. 2.
S a m ple Si ze Deter mi nat i on .........................................................................................4 1
9. 3.
P o p ul at i ons f or A nal yses ............................................................................................4 1
9. 4.
Stati stical A nal yses .....................................................................................................4 1
9. 4. 1.
Ge neral C o nsi derati o ns ...............................................................................................4 2
9. 4. 2.
Pri mar y E n d p o i nt: P har mac o ki net ics ..........................................................................4 2
9. 4. 3.
Sec o n dar y  E n d p oi nt: Safety ........................................................................................4 2
9. 4. 4.
E x pl or at or y  E n d p oi nt: I njecti on Si te Reactio n Assess me nts ........................................4 3
9. 5.
I nteri m A nal yses.........................................................................................................4 3
9. 6.
Data M o nit ori n g C o m mittee ( D M C) ...........................................................................4 3
1 0.
S u p p orti n g D oc u me nt ati o n a n d O per ati o n al C o nsi der ati o ns ................................4 4
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 ............................................................................................................4 4
1 0. 1. 1.
Re g ulat or y  a n d Et hical C o nsi derati ons ........................................................................4 4


C O N FI D E N TI A L
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1 0. 1. 2.
I nf or me d C o nse nt Pr ocess ..........................................................................................4 4
1 0. 1. 3.
Data Pr otecti o n ...........................................................................................................4 5
1 0. 1. 4.
Di sse mi nati on of Cli nical St u d y  Data .........................................................................4 5
1 0. 1. 5.
Data Q ualit y Ass ura nce ..............................................................................................4 5
1 0. 1. 6.
S o urce D oc u me nts ......................................................................................................4 7
1 0. 1. 7.
St u d y  a n d Site Start a n d Clos ure .................................................................................4 7
1 0. 1. 8.
P u blicat i on P olic y .......................................................................................................4 8
1 0. 1. 9.
I n vesti gat or I nf or mati on .............................................................................................4 8
1 0. 1. 1 0. L o n g -Ter m  Sa m ple Rete nti on .....................................................................................4 8
1 0. 2.
A p pe n di x 2: Cli nical La b orat or y  Tests........................................................................4 9
1 0. 2. 1.
Bl o o d S a m pli n g S u m mar y ..........................................................................................5 1
1 0. 3.
A p pe n di x 3: A d verse E ve nts: Defi nit i ons a n d Pr oce d ures f or 
Rec or di n g, E val uat i n g, F oll o w-u p, a n d Re p orti n g .......................................................5 2
1 0. 3. 1.
Defi nit i on o f A E .........................................................................................................5 2
1 0. 3. 2.
Defi nit i on o f S A E .......................................................................................................5 3
1 0. 3. 3.
Rec or di n g a n d F o ll ow- U p of A E a n d/ or S A E .............................................................5 4
1 0. 3. 4.
Re p orti n g of S A Es ......................................................................................................5 6
1 0. 4.
A p pe n di x 4: C o ntrace pti ve G ui da nce a n d C o llecti o n of 
Pre g na nc y I nf or mati o n ...............................................................................................5 7
1 0. 4. 1.
W o me n .......................................................................................................................5 7
1 0. 4. 2.
Me n ............................................................................................................................5 7
1 0. 4. 3.
C ollect i on of Pre g na nc y  I nfor m at i on ..........................................................................5 8
1 0. 5.
A p pe n di x 5: Ge netics ................................................................................................. 6 0
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 ...............................................................................................................6 1
1 0. 7.
A p pe n di x 7: Rec o m me n de d La b orat or y Test i n g f or 
H y perse nsi tivi t y E ve nts..............................................................................................6 3
1 0. 8.
A p pe n di x 8: A b bre viat i ons .........................................................................................6 5
1 1.
Refere nces .................................................................................................................6 8


CONFIDENTIAL
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1.
Protocol Summary
1.1.
Synopsis
Protocol Title: A Randomized, Placebo-Controlled, Participant- and Investigator-Blind, Phase 1 
Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of LY3832479 Administered 
Subcutaneously to Healthy Participants
Short Title: A Randomized, Placebo-Controlled, Phase 1 Study to Evaluate the 
Pharmacokinetics, Safety, and Tolerability of LY3832479 Administered Subcutaneously to 
Healthy Participants
Rationale: The clinical program for LY3832479 so far has involved IV dosing of LY3832479.
Study PGAB will investigate SC dosing of LY3832479. Single SC doses of LY3832479, 350 mg
and 1000 mg, will be administered to establish the PK, safety, and tolerability profiles in healthy 
participants.
Objectives and Endpoints
Objectives
Endpoints
Primary
To determine the PK of single SC doses of 
LY3832479 in healthy participants
AUC(0-∞) and Cmax
Secondary
To describe safety and tolerability following 
single SC doses of LY3832479 in healthy 
participants
Incidence of spontaneously reported AEs, 
TEAEs, and SAEs; vital signs; clinical 
laboratory results
Abbreviations: AE = adverse event; AUC(0-∞) = area under the concentration versus time curve from time 0 to 
infinity; Cmax = maximum observed drug concentration; ISR = injection site reaction; PK = pharmacokinetics; 
SAE = serious adverse event; SC = subcutaneous; TEAE = treatment-emergent adverse event.


C O N FI D E N TI A L
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O ver all Desi g n
T his is a si n gle -sit e st u d y in healt h y partici pa nts w h o will recei ve a si n gle S C d ose of 
L Y 3 8 3 2 4 7 9. T he st u d y  will be partici pa nt - a n d i n vesti gat or -bli n de d, ra n d o mize d, a n d place b o
c o ntr olle d .
Discl os ure St ate me nt : T hi s is a P K a n d safet y stu d y t o test L Y 3 8 3 2 4 7 9 a n d place b o i n u p t o 2 
d ose c o h orts .
N u m ber of P artici p a nt s:
A ma xi m u m of  22 p artici pa nts, i n 2 c o h orts of at least 9 partici pa nts, will be e nr o lle d t o st u d y 
i nter ve nt i on wi t h t he i nte nti on t hat at l east 6  partici pa nts ra n d o mize d t o L Y 3 8 3 2 4 7 9 ha ve 
s ufficie nt e val ua ble data i n eac h c o h ort .
I nter ve nti o n Gr o u ps a n d D ur ati o n :
T his is a si n gle -d ose st u d y  wit h a n esti mate d d urati on f or eac h partici pa nt of u p t o 1 6 we e ks 
fr om scree ni n g t hr o u g h f oll ow- u p. Partici pa nts will be scree ne d wit hi n 1 4 da ys pri or t o Da y  1 of 
d osi n g f or eac h c o h ort , wit h a n all owa ble wi n d o w of u p t o 2 8 da y s.
D at a M o nit ori n g C o m mittee: N o
1. 2.
Sc he m a
A b bre viat i ons: L Y = L Y 3 8 3 2 4 7 9 ; P B O = place b o; S C = s u bc uta ne o us.


C O N FI D E N TI A L
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1. 3.
Sc he d ule of Acti vities ( S o A)
Pr oce d ure / 
Assess me nts
Scree ni n g
Tre at me nt Peri o d
F oll o w -u p Visits
C o m me nt
Visit N u m ber
V 1
V 2
V 3  
V 4  
V 5
V 6/
E D
Wee k(s)
0
2 
4 
8 
1 2
St u d y D a y
- 1 4
t o – 1
- 1 
1 
2 
3 
4 
5 
6 
7 
1 5
± 2 d
2 9
± 3 d
6 0
± 3 d
8 5
± 3 d
I nf or me d 
c o nse nt 
( writte n)
X
Re vie w/
c o nfir m I/ E 
criteria
X  
X
After scree ni n g, e ns ure 
partici pa nts c o nti n ue t o meet 
I/E criteria.
Me dical 
h ist or y
i ncl u di n g pre-
e xisti n g 
c o n diti o ns
X
Wei g ht/ hei g ht
X
X
Hei g ht at scree ni n g o nl y.
Uri nal ysis
X
X
C O VI D - 1 9 
cli nical 
scree ni n g
X  
X
X  
X  
X  
X
S y m pt o ms a n d rece nt 
c o ntact (see Secti o n 5. 2 f or a 
descri pti o n of s y m pt o ms a n d 
cl ose c o ntact). At desi g nate d 
ti me p oi nts a n d as nee de d 
d uri n g t he st u d y.
S A R S -C o V - 2 
ser ol o g y
X
X  
X  
X  
X
Ser ol o g y res ults are n ot 
nee de d bef ore d osi n g.


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Pr oce d ure / 
Assess me nts
Scree ni n g
Tre at me nt Peri o d
F oll o w -u p Visits
C o m me nt
Visit N u m ber
V 1
V 2
V 3  
V 4  
V 5
V 6/
E D
Wee k(s)
0
2 
4 
8 
1 2
St u d y D a y
- 1 4
t o – 1
- 1 
1 
2 
3 
4 
5 
6 
7 
1 5
± 2 d
2 9
± 3 d
6 0
± 3 d
8 5
± 3 d
S A R S -C o V - 2 
p oi nt -of -care 
test
X  
X
A d diti o nal p oi nt -of -care 
tests ma y be c o n d ucte d at 
t he i n vesti gat or’s discreti o n. 
See Secti o n 8. 3. 7 .
Nas o -
p har yn geal
s wa b
X
Ca n be bef ore or after 
L Y 3 8 3 2 4 7 9 a d mi nistrati o n. 
F or researc h p ur p oses. See 
Secti o n 8. 3. 7 .
Nasal s wa b
X
F or researc h p ur p oses. T h is
swa b ma y be ta ke n if a 
p oi nt -of -care test is d o ne 
d uri n g t he st u d y, as 
descri be d i n Secti o n 8. 3. 7 .
A d missi o n t o 
st u d y site
X
Disc har ge 
fr o m st u d y
site
X
P h ysical 
e xa mi nati o n
M e dical 
assess me nt
X  
X
Pre d ose
X
X
As nee de d
X
F ull P E/ M A at scree ni n g 
a n d Visit 6 / E D. S y m pt o m -
directe d P E /M A
at all ot her
i n dicate d ti me p oi nts a n d as 
dee me d necessar y b y t he 
i n vesti gat or or desi g nee .


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Procedure / 
Assessments
Screening
Treatment Period
Follow-up Visits
Comment
Visit Number
V1
V2
V3
V4
V5
V6/
ED
Week(s)
0
2
4
8
12
Study Day
-14
to –1
-1
1
2
3
4
5
6
7
15
±2d
29
±3d
60
±3d
85
±3d
Vital signs: 
blood pressure, 
body 
temperature, 
pulse ratea
X
X
Predose
24 h 
(±2 h)
X
X
X
X
X
X
Vital signs should be taken 
following at least 5-min rest 
in a supine position. Vital 
signs may be taken any time 
prior to dosing. If screening 
takes place on Day -1, there 
is no need to take vital signs 
twice on Day -1.
Single 12-lead 
ECG
X
X
ECG should be taken 
following at least 5-min rest 
in a supine position.
Concomitant 
medications 
review
X
X
X
X
X
X
AE review
X
X
Predose
X
X
X
X
X
X
X
X
X
X
AEs to be reviewed only 
after participant has signed 
the study ICF.
HIV, hepatitis 
B/C serology
X


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Procedure / 
Assessments
Screening
Treatment Period
Follow-up Visits
Comment
Visit Number
V1
V2
V3
V4
V5
V6/
ED
Week(s)
0
2
4
8
12
Study Day
-14
to –1
-1
1
2
3
4
5
6
7
15
±2d
29
±3d
60
±3d
85
±3d
Pregnancy test
(women only)b
X
X
X
Serum pregnancy test at 
screening, urine test at other 
timepoints. Day -1 urine test 
refers to test at admission; 
this is not needed if 
admissions is on the same 
day as screening. Postdose 
urine test(s) can be 
performed at the judgment 
of the investigator, if 
pregnancy is suspected.
Clinical 
laboratory
testsa
X
X
X
X
X
X
X
Fasting is not required for 
these tests. If screening takes 
place on Day -1, there is no 
need to conduct these tests 
twice on Day -1.
Breath or urine 
ethanol screen
X
Ethanol screen may be 
repeated at other time points 
at the discretion of the 
investigator.
Urine drug 
screen
X
X
Day -1 urine test refers to 
test at admission; this is not 
needed if admission occurs 
on the same day as 
screening. Drug screen may 
be repeated at other time 
points at the discretion of the 
investigator.


C O N FI D E N TI A L
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1 2
Pr oce d ure / 
Assess me nts
Scree ni n g
Tre at me nt Peri o d
F oll o w -u p Visits
C o m me nt
Visit N u m ber
V 1
V 2
V 3  
V 4  
V 5
V 6/
E D
Wee k(s)
0
2 
4 
8 
1 2
St u d y D a y
- 1 4
t o – 1
- 1 
1 
2 
3 
4 
5 
6 
7 
1 5
± 2 d
2 9
± 3 d
6 0
± 3 d
8 5
± 3 d
S C 
L Y 3 8 3 2 4 7 9 or 
place b o d osi n g
X
L Y 3 8 3 2 4 7 9 
P K sa m pli n g a
X
X
X 
X  
X  
X  
X  
X  
X  
X  
X
Da y 1 c ollecti o n s h o ul d be 
4 - 8h p ost d ose . T he e xact 
ti me of dra w m ust be 
rec or de d.
F or Da y 2 o n war ds, P K 
sa m ples ma y be ta ke n at a n y 
ti me after vital si g ns.
I njecti o n site 
assess me nts c
Pre d ose; 
1 m i n ± 1 mi n , 
1 0 mi n
± 2 mi n , 
3 0 m i n 
± 5 mi n , 
2 4 0 mi n 
± 1 0 mi n
2 4 h 
± 4 h
X  
X  
X  
X  
X  
X  
X
T i me p oi nts i ncl u de I S R 
assess me nt, V A S , if pai n is 
re p orte d, a n d t he e x pl orat or y 
Scarletre d t o ol. Scarletre d 
ti mi n g is fle xi ble a n d not 
c o nfi ne d t o t he wi n d o ws 
s h o w n, e xce pt f or pre d ose .
See Secti o n 8. 2. 6 f or detail.
I m m u n o ge n-
icit y
Pre d ose
X  
X  
X  
X
Ser u m sa m ple 
f or e x pl orat or y 
bi o mar kers a
Pre d ose
X
X  
X  
X  
X
P har mac o -
ge netics 
sa m plea
Pre d ose
F or st ora ge o nl y.


C O N FI D E N TI A L
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A b bre viati o ns: A E = a d verse e ve nt; C O VI D -1 9 = C or o na vir us disease -2 0 1 9; E C G = electr ocar di o gra m; E D = earl y disc o nti n uati o n; h = h o urs; HI V = h u ma n 
i m m u n o deficie nc y vir uses; I/ E = i ncl usi o n/e xcl usi o n; IC F = i nf or me d c o nse nt f or m; M A = me dical assess me nt; I S R = i njecti o n site reacti o n; m i n = mi n utes; 
P E = p h y sical e xa mi nati o n; P K = p har mac o ki netics; 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; S C = s u bc uta ne o us ; V = visit; V A S = 
vis ual a nal o g scale .
a
W he n c o n d ucte d o n t he sa me da y, t he or d er  of pr oce d ures s h o ul d be vital si g ns, E C G, a n d t he n bl o o d sa m pli n g.
b
F or w o me n w h o are c o nsi dere d t o be p ost me n o pa usal, f ollicle-sti m ulati n g h or m o ne s ho ul d be dra w n t o c o nfir m p ost me n o pa usal stat us if necessar y, acc or di n g 
t o A p pe n di x 4 ( Secti o n 1 0. 4 ).
c
In case a n I S R is still prese nt o n Da y 2 9, a d diti o nal I S R assess me nts will be perf or me d at s u bse q ue nt visits. I n case a n I S R is prese nt o n a n earl y
disc o nti n uati o n visit, a n I S R assess me nt s h o ul d be perf or me d at t his visit.


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2.
Introduction
2.1.
Study Rationale
The clinical program for LY3832479 so far has involved IV dosing of LY3832479 to healthy 
participants.
Study PGAB, will investigate SC dosing of LY3832479. Single SC doses of LY3832479,
350 mg and 1000 mg, will be administered to establish the PK, safety, and tolerability profiles in 
healthy participants.
2.2.
Background
The viral pathogen causing the COVID-19 pandemic is the SARS-CoV-2. Viral entry into host 
cells involves its structural Spike glycoprotein. The Spike glycoprotein attaches itself via its 
RBD to the human ACE2, enabling sufficient proximity for the virus to fuse with the target cell 
membrane. Angiotensin-converting enzyme 2 is expressed in the membrane of various cell types 
in a variety of tissues, primarily in the lung, small intestine, kidney, and vascular endothelium 
(Hamming et al. 2004; Human Protein Atlas Project [WWW]). There are no approved therapies 
to date for the treatment of COVID-19; Remdesivir and convalescent plasma are available under 
an emergency use authorization in the United States (FDA 2020 [WWW]; Gilead Sciences 
2020).
LY3832479 is a neutralizing IgG-1 mAb that specifically binds the Spike glycoprotein RBD 
with high affinity, preventing its interaction with the ACE2 human receptor. This in turn blocks 
viral cell fusion, preventing SARS-CoV-2 invasion of human cells, inhibiting viral replication. 
As the binding epitope of LY3832479 to RBD covers the most conserved RBD/ACE2 
interaction site based on an analysis of the LY3832479-RBD complex x-ray structure, 
LY3832479 is expected to neutralize all currently described viral strains.
The amino acid sequence of recombinant antibody LY3832479 was derived from human 
memory B cells of a convalescent patient with COVID-19. Point mutations (L234A, L235A; 
LALA mutation) were introduced into the Fc domain of the native human IgG1 antibody to 
eliminate Fc effector function, to reduce the risk of ADE.
Preclinical experience with LY3832479
Nonclinical safety studies conducted to date using the IV route of administration have not 
demonstrated safety concerns. Toxicity studies supporting LY3832479 clinical trials consist of a 
tissue cross-reactivity study in human and cynomolgus tissues, a 21-day cynomolgus monkey
toxicity study (IV administration), and an evaluation of ADE in vitro. Tissue cross-reactivity 
data did not suggest off-target binding of clinical relevance and supports use of the cynomolgus 
monkey as the nonclinical safety model. No test article-related effects were identified, other than 
a reversible non-adverse increase in IgG serum concentration in the 21-day repeat-dose toxicity 
study in cynomolgus monkeys; therefore, the NOAEL was 205 mg/kg (highest dose tested). 
Lastly, no evidence for ADE was observed in vitro. An in vivo ADE assessment in African green 
monkeys is in process; additional data will be communicated when results are available.


C O N FI D E N TI A L
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1 5
Cli nic al e x perie nce wit h L Y 3 8 3 2 4 7 9
L Y 3 8 3 2 4 7 9 has bee n a d mi nistere d t o h u ma ns i n 2 cli nical st u dies t hat are still o n g o i n g, St u d y  
J S 0 1 6- 0 0 1-I a n d St u d y P G A A .
St u d y J S 0 1 6 - 0 0 1-I
T he FI H St u d y  J S 0 1 6- 0 0 1-I e nr olle d 4 0 healt h y C hi nese partici pa nts w h o recei ve d a si n gle I V 
i nf usi on of 2. 5 -, 1 0-, 2 5-, a n d 5 0-m g/ k g of  L Y3 8 3 2 4 7 9 ( n = 4 0) or pl ace b o ( n = 1 0).
As of 1 7 J ul y 2 0 2 0 ( C o h ort 1 c o m plete d D 3 6, C o h ort 2 c o m plete d D 2 2, C o h ort 3 c o m plete d 
D 1 5, a n d C o h ort 4 c o m plete d D 8) , n o S A E s were re p orte d ; a n d L Y 3 8 3 2 4 7 9 a p peare d well 
t olerate d wit h o ut a n y  i de ntifie d safety si g nal. T he m ost c o m m o n  cli nical T E A E was u p per 
res pir at or y tract i nfecti on ( 3 cases).
St u d y P G A A
T he P hase 1 , si n gle asce n di n g d ose St u d y  P G AA e nr olle d 2 6 healt h y part ici pa nts i n t he U nite d 
States , w h o recei ve d a si n gle I V i nf usi o n of 7 0 0 m g ( n = 7) , 2 8 0 0 m g ( n = 7) , a n d 7 0 0 0 m g of
L Y 3 8 3 2 4 7 9 ( n =6 ) or place b o ( n =6 ).
As of 1 1 J ul y 2 0 2 0 , ( C o h ort 1 c o m plete d D 1 5, C o h ort 2 c o m plete d D 8, a n d C o h ort 3 c o m plete d 
D 4), n o S A E s were re p orte d ; a n d L Y3 8 3 2 4 7 9 a p peare d well t olerate d wit h o ut a n y ide ntifie d 
safety si g nal. T he m ost c o m m o n  T E A E was hea dac he, re p orte d i n 1 s u bject fr om C o h ort 1 a n d 2 
s u bjects fr om C o h ort 2 . All T E A Es were mil d a n d res ol v e d s p o nta ne o usl y.
S er u m  dr u g c o nce ntrati o ns ha ve bee n o btai ne d u p t o st u d y  D a y 5 7 i n S t u d y P G A A. Base d o n 
t hese preli mi nar y d at a, t he o bser ve d P K is c o nsiste nt wit h pre vi o us m o del pre dicti ons ( base d o n 
all o metric scali n g fr o m m o n ke y P K) ; a n d t he mea n half -life is e x pecte d t o be i n t he ra n ge of 2 2
t o 2 5 da ys . T he c urre nt data als o i n dicate t he P K t o be d ose- pr o p orti o nal . Preli mi nar y  P K data 
fr om St u d y  J S 0 1 6- 0 0 1-I als o a p peare d t o be si milar t o t hat  of St u d y  P G A A .
A d dit i onal i nf or mati o n ca n be f o u n d i n t he I B.
2. 3.
Be nefit/ Ris k Assess me nt
T here i s n o a nticipate d t hera pe u tic be nefit for t he parti ci pa nts.
T he m a xi m u m pla n ne d d ose of L Y 3 8 3 2 4 7 9 i n t his st u d y is 10 0 0 m g S C. T hi s is lo wer t ha n t he 
ma xi m u m d ose deli vere d I V i n pre vi o us st u dies.
P ote nti al ris ks relate d t o S C i njecti ons of  L Y 3 8 3 2 4 7 9 are as f o ll ows :

H y perse nsi tivi t y reacti ons a n d I S Rs: St u d y  partici pa nts will be i n- h o use f or t he first 7
da ys after d osi n g, w hic h will e na ble cl ose m o nit ori n g f or h y perse nsi tivi t y reacti ons a n d 
I S Rs p ost-i njecti on.

A nt i b o d y-de pe n de nt e n ha nce me nt of viral re plicat i o n i n case a n y of t hese health y 
v o l unt eers c o ntract a S A R S -C o V -2 i nfect i on w hile t he y still ha ve si g nifica nt L Y 3 8 3 2 4 7 9 
e x p os ure after d osi n g : T his p he n o me n o n has bee n o bser ve d wit h s o me ot her vir uses 
i ncl u di n g t he de n g ue vir us, b ut is o nl y a t he oretical ris k with o ut cli nical e vi de nce i n t he 
case of res pirat or y c or o na vir uses ( Gra ha m 2 0 2 0). I n a d diti on, L Y 3 8 3 2 4 7 9 was 
s pecificall y e n gi neere d t o a v oi d t his ris k as e x plai ne d i n Secti o n 2. 2 .


CONFIDENTIAL
J2Z-MC-PGAB
16

Unknown risks related to on-target and off-target toxicity. These risks are low due to the
o
fact that LY3832479 targets a foreign protein
o
human origin of LY3832479 (the LALA mutations do not involve the RBD of 
LY3832479), and
o
absence of binding in the TCR studies performed in humans and monkeys.
Given the totality of data on LY3832479, the overall benefit/risk assessment of this study is 
considered favorable.
More detailed information about the known and expected benefits and risks and reasonably 
expected AEs of LY3832479 may be found in the IB.


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3.
Objectives and Endpoints
Objectives
Endpoints
Primary
To determine the PK of single SC doses of 
LY3832479 in healthy participants
AUC(0-∞) and Cmax
Secondary
To describe safety and tolerability following 
single SC doses of LY3832479 in healthy 
participants
Incidence of spontaneously reported AEs, 
TEAEs, and SAEs; vital signs; clinical 
laboratory results
Exploratory
To assess ISRs following single SC doses of 
LY3832479 in healthy participants
Characterization and measurement of 
incidence and severity of ISRs (including 
injection site pain) using data collected from 
the ISR assessment, as well as the exploratory 
tool (Scarletred)
To determine the immunogenicity of 
LY3832479 following single SC doses in 
healthy participants
Incidence of TEADA
Abbreviations: AE = adverse event; AUC(0-∞) = area under the concentration versus time curve from time 0 to 
infinity; ISR = injection site reaction; PK = pharmacokinetics; SAE = serious adverse event; SC = subcutaneous; 
TEADA = treatment-emergent antidrug antibodies; TEAE = treatment-emergent adverse event.


C O N FI D E N TI A L
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1 8
4.
St u d y Desi g n
4. 1.
O ver all Desi g n
T his is a si n gle -sit e st u d y in healt h y partici pa nts w h o will recei ve a si n gle S C d ose of 
L Y 3 8 3 2 4 7 9. T he s t u d y will be partici pa nt - a n d i n vesti gat or -bli n de d, ra n d o mize d, a n d place b o
c o ntr olle d .
4. 1. 1.
Scree ni n g a n d E nr oll me nt
U p t o 2 c o h orts ma y be e nr olle d wit h at least 9 partici pa nts per c o h ort ( 7 L Y 3 8 3 2 4 7 9 : 2 place b o ), 
wi t h t he i nte nti on t hat at least 6   partici pa nts ra n d o mize d t o L Y 3 8 3 2 4 7 9 ha ve s ufficie nt e val ua ble
data i n eac h c o h ort.
P arti cipa nts will be scree ne d wit hi n 1 4 da ys pri or t o Da y  1 of d osi n g f or eac h c o h ort , wit h a n 
all o wa ble wi n d o w of u p t o 2 8 da ys (see Sec tio n 5. 4 ). Partici pa nts will be a d mitte d t o t he C R U as 
part of a n i n pat ient  visit o n Da y -1 a n d will be se q ue nt iall y e nr olle d a n d t he n ra n d o mize d t o 
treat me nt.
4. 1. 2.
I n p atie nt S t a y
P arti cipa nts will be a d mit te d t o t he st u d y site o n Da y - 1. T he y will re mai n i n patient  u ntil 
di sc har ge o n Da y 7 after st u d y pr oce d ures are c o m plete.
D osi n g
D osi n g will occ ur o n Da y  1. I nte n de d d oses of L Y 3 8 3 2 4 7 9 are as f o ll ows:

C o h ort 1 : 3 5 0 m g

C o h ort 2: 1 0 0 0 m g
See Secti o n 6. 1 f or detail of i njecti on v o l umes.
P arti cipa nts will u n der g o P K sa m pli n g a n d safet y assess me nt after d osi n g.
F or C o h ort 1, a safety re vie w will be co n d ucte d t o deter mi ne w het her it is a p pr o priate t o pr ocee d 
wi t h d osi n g of t he ne xt c o h ort. T hi s safet y re vie w will be c o n d ucte d base d o n data fr o m at least 5
parti ci pa nts assi g ne d t o L Y 3 8 3 2 4 7 9 , after at least 4 da y s after d osi n g.
P ost d ose s a m pli n g
O n Da ys 1 t hr o u g h 7, partici pa nts will u n der g o P K sa m pli n g a n d safet y assess me nt as s h o w n i n 
t he S o A ( Sectio n 1. 3 ).
4. 1. 3.
O ut p atie nt F oll o w - U p
F o ll ow- u p visits will be c o n d ucte d t hr o u g h D a y 8 5, as s h o w n i n t he So A ( Secti o n 1. 3 ).
I n t he e ve nt a partici pa nt has s us pecte d or c o nfir me d S A R S-C o V - 2 i nfecti on, f o ll ow- u p visi ts 
ma y be c o n d ucte d at t he partici pa nt’s h o m e.


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4.2.
Scientific Rationale for Study Design
This is the first study to evaluate a new formulation of LY3832479 (125 mg/mL in 20 mM 
L-histidine pH 6.0, 8.04% sucrose, 0.05% polysorbate 80, and water for injection) in humans via 
SC administration. This study will be conducted with healthy participants, rather than patients 
with COVID-19, because the important biopharmaceutic questions related to the new SC route of 
administration, such as PK and tolerability, will be more efficiently investigated in the healthy 
human population.
The 4-day safety review together with inpatient status after dosing is sufficient to detect an acute 
adverse systemic response that would preclude dose escalation.
Placebo will be used as a comparator to allow interpretation of safety and tolerability data 
following administration of LY3832479.
4.3.
Justification for Dose
Previous studies have evaluated LY3832479 IV doses in a range of 700 mg to 7000 mg and 
shown to be safe and well tolerated, using the LY3832479 drug product (40 mg/mL in 20 mM 
L-histidine, pH 6.0, 4.5% mannitol, 0.02% polysorbate 80, and water for injection).
For Study PGAB, the planned doses of LY3832479 350 mg and 1000 mg have been chosen to 
evaluate PK following this new SC route of administration.
The SC doses of 350 mg and 1000 mg are expected to result in much lower plasma 
concentrations (Cmax and AUC) in comparison to the previously studied upper IV dose of
7000 mg. The upper SC dose of 1000 mg is primarily limited by study drug concentration of 
125 mg/mL, which requires 4 SC injections of 2 mL.
4.4.
End of Study Definition
A participant is considered to have completed the study if he/she has completed all required
phases of the study including the last scheduled procedure shown in the SoA.
The end of the study is defined as the date of last scheduled procedure shown in the SoA for the 
last participant.


C O N FI D E N TI A L
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5.
St u d y P o p ul ati o n
Pr os pecti ve a p pr o val o f pr ot oc ol  de viatio ns t o recr ui t me nt a n d e nr o ll me nt criteria, als o k n o w n as 
pr ot oc ol  wai vers or e xe m pti ons, is n ot per mitte d.
5. 1.
I ncl usi o n Criteri a
P arti cipa 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 o f t he fol l owi n g criteria a p pl y:
A ge
1.
are a ge d 1 8 t o 6 0 years at t he ti me of si g ni n g t he i nf or me d c o nse nt
T y pe of P artici p a nt a n d Dise ase C h ar acteristics
2.
are o vertl y healt h y as de ter mi ne d b y me dical e val uati o n i ncl u di n g me dical hist or y a n d 
p h ysical e xa mi nat i on
3.
ha ve safet y la b orat or y test res ults wit hi n t he refere nce ra n ge f or t he p o p ulat i on at t he
st u d y site, or res ults wit h acce pta ble de viati ons t hat are j u d ge d t o be n ot cli nicall y 
sig nifica nt b y  t he i n vesti gat or
4.
ha ve ve n o us access s ufficie nt t o all o w f or bl o o d sa m pli n g as descri be d i n t his pr ot oc ol 
( S o A, Sectio n 1. 3 )
5.
are relia ble a n d willi n g t o ma ke t he mselves a vaila ble f or t he d urati o n of t he st u d y
6.
are willi n g t o f o ll ow st u d y  pr oce d ures, i ncl u di n g ha v i n g nasal or nas o p har y n geal s wa bs
c ollecte d as descri be d i n t his pr ot oc ol ( S o A, Secti o n 1. 3 )
Wei g ht
7.
ha ve a B MI wi t hi n t he ra n ge ≥1 8. 5 t o < 3 5 k g/ m 2
Se x
8.
are m ale or fe male
a.
m ale partici pa nts m u st a gree t o a d here t o c o ntrace pti o n restricti ons
b.
fe male partici pa nts m u st be of n o n -c hil d beari n g p ote ntial
C o ntrace pti o n re q uire me nts a n d defi nit i on of n o n -c hil d beari n g p ote ntial are detaile d i n 
A p pe n di x 4 ( Secti o n 1 0. 4 ).
I nf or me d C o nse nt
9.
are ca pa ble of gi vi n g si g ne d i nf or m e d c o nse nt as descri be d i n A p pe n di x 1 ( Sectio n 1 0. 1 ),
w hic h i ncl u des c om p lia nce with t he re q uire me nts a n d restricti o ns liste d i n t he I C F a n d i n 
t his pr ot oc ol
5. 2.
E xcl usi o n Criteri a
P arti cipa nts are e xcl u de d fr o m  t he st u d y if a n y of t he f o ll owi n g cri t eria a p pl y:
Me dic al C o n diti o ns
1 0. ha ve c urre nt S A R S -C o V -2 i nfect i on c o nfir me d b y nasal or nasal p har y n geal s wa b res ults 
at scree ni n g or Da y  - 1 ( p oi nt-of -care test or a n y ot her a d diti onal test o n s uc h s wa bs )


CONFIDENTIAL
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11. have had prior SARS-CoV-2 infection within 6 weeks before screening, confirmed by 
either previous nucleic acid-based test, or previous serology
12. have suspected current SARS-CoV-2 infection, in the opinion of the investigator, based 
on either or both of the following:
a.
a recent exposure to SARS-CoV-2, defined as

living in the same household as a person with SARS-CoV-2

having had direct physical contact with a person with SARS-CoV-2 (for 
example, shaking hands)

having unprotected direct contact with infectious secretions of a person with 
SARS-CoV-2 (for example, being coughed on or touching used paper 
tissues with a bare hand); or

having had face-to-face contact with a person with SARS-CoV-2, within 
2 m and for more than 15 minutes
b. signs or symptoms that, in the opinion of the investigator, are suggestive of 
infection (for example, fever, dry cough, shortness of breath, hypoxia, etc.)
13. have a history or presence of cardiovascular (including hypertension), respiratory, 
hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric, or neurological 
disorders that, in the opinion of the investigator, are capable of
a.
significantly altering the absorption, metabolism, or elimination of drugs
b. constituting a risk while taking the investigational product, or
c.
interfering with the interpretation of data
14. have clinically significant abnormal ECG results constituting a risk while taking the 
investigational product, as determined by the investigator
15. have an abnormal blood pressure as determined by the investigator. In case blood 
pressure appears to be abnormally high during the screening period, it is possible to 
repeat the measure(s) 1 time in a quiet room to avoid an exclusion due to the white coat 
effect
16. have significant allergies to humanized mAbs
17. have any of the following that are clinically significant:
a.
multiple or severe drug allergies
b. intolerance to topical corticosteroids, or
c.
severe posttreatment hypersensitivity reactions (including, but not limited to, 
erythema multiforme major, linear immunoglobulin A dermatosis, toxic 
epidermal necrolysis, or exfoliative dermatitis)
18. have known allergies to LY3832479, related compounds, or any components of the 
formulation
19. have had lymphoma, leukemia, or any malignancy within the past 5 years, except for 
basal cell or squamous epithelial carcinomas of the skin that have been resected with no 
evidence of metastatic disease for 3 years
20. have had breast cancer within the past 10 years
21. show evidence of HIV infection and/or positive human HIV antibodies
22. show evidence of current hepatitis C (that is, test positive for anti-hepatitis C antibody 
with confirmed presence of HCV RNA)


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Note: Patients with a previous diagnosis of hepatitis C who received antiviral therapy and 
achieved a sustained virological response may be eligible for inclusion in the study, 
provided that they have no detectable HCV RNA on the screening HCV polymerase 
chain reaction test for this protocol. A sustained virological response is defined as an 
undetectable HCV RNA level 24 weeks after completion of a full, documented course of 
an approved antiviral therapy for HCV.
Patients who have spontaneously cleared HCV infection, defined as (1) a positive HCV
antibody test and (2) a negative HCV RNA test, with no history of HCV antibody (anti-
HCV) treatment, may be eligible for inclusion in the study, provided that they have no
detectable HCV RNA at screening for this study.
23. have history of hepatitis B infection, or show evidence of current hepatitis B:
a.
test positive for hepatitis B surface antigen, and/or
b. test positive for hepatitis B core antibody and negative for hepatitis B surface 
antibody
Prior/Concomitant Therapy
24. have received treatment with biologic agents (such as mAbs, including marketed drugs
and drugs given emergency use authorization) within 3 months or 5 half-lives (whichever 
is longer) prior to dosing
25. have previously completed or withdrawn from this study and have previously received 
LY3832479
26. intend to use over-the-counter medication in the 7 days prior to dose administration or 
prescription medication in the 14 days prior to dose administration, with the exception of 
hormone replacement therapy, thyroid replacement medications, vitamin and mineral 
supplements, and occasional use of acetaminophen. Note that acetaminophen is NOT 
allowed within 24 hours before dosing.
Prior/Concurrent Clinical Study Experience
27. are currently enrolled in a clinical study involving an investigational product or any other 
type of medical research judged not to be scientifically or medically compatible with this 
study
28. have participated in a clinical study involving an investigational product, with last dose
within the past 30 days or 5 half-lives, whichever is longer, prior to dosing
Other Exclusions
29. are pregnant or breast feeding
30. have donated blood of more than 500 mL within the previous 3 months of study 
screening, or intend to donate blood during the course of the study
31. have an average weekly alcohol intake that exceeds 21 units per week (males) or 14 units 
per week (females), or are unwilling to stop alcohol consumption from 48 hours prior to 
admission to and while resident at the CRU (1 unit = 12 oz or 360 mL of beer; 5 oz or 
150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
32. currently smoke in excess of 10 cigarettes per day or are unwilling to abide by CRU 
smoking restrictions


C O N FI D E N TI A L
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2 3
3 3. re g ularl y use k n o w n dr u gs of a b use a n d/ or s h o w p osit i ve fi n di n gs o n dr u g scree ni n g 
u nless t he y  were prescri be d b y a p h ysicia n (f or e xa m ple, be nz o diaze pi nes)
3 4. are Lill y em pl o yees or are e m pl o yees of a t hir d -p art y  or ga nizat i on i n v ol ve d wi t h t he 
st u d y t hat re q uires e xcl usio n of  its e mpl o y ees are st u d y site pers o n nel direct l y affiliate d 
wi t h t his st u d y or t heir i m me diate fa milies. I m me diate fa mil y is defi ne d as a s p o use, 
bi o l ogical  or le gal g uar dia n, c hil d, or si bli n g.
3 5. h a ve tatt o os or scars o ver t he a b d o me n, or ot her fact ors (f or e xa m ple, ras h or e xcessi ve 
f ol ds of s ki n) t hat, i n t he i n vesti gat or's o pi ni on, w o ul d i nterfere wi t h injecti o n si t e 
assess me nts
3 6. i n t he o pi ni on of t he i n vest i gat or or s p o ns or, are u ns uita ble f or i ncl usi on i n t he st u d y
5. 3.
Lifest yle C o nsi der ati o ns
Re pr o d ucti ve a n d co ntrace pti ve g ui da nce is pr o vi de d i n A p pe n di x 4 ( Secti o n 1 0. 4 ).
5. 3. 1.  
Me als a n d Diet ar y Restricti o ns
P arti cip a nts will be re q uire d t o fast (e xce pt f or water) f or at least 2 h o u rs bef ore bei n g gi ve n a 
d ose of L Y 3 8 3 2 4 7 9 (see S o A , Sectio n 1. 3 ). Sta n dar d meals will be a d mi nistere d w hile 
parti ci pa nts are resi de nt at t he stu d y sit e.
5. 3. 2.  
C affei ne, Alc o h ol, a n d T o b acc o
P arti cipa nts m u st a bide b y  t he C R U restrict i on p olic y  re gar di n g c o ns u m pti on of caffei ne, 
alc o h o l, a n d t o bacc o.
5. 3. 3.
Acti vit y
P arti cipa nts s h o ul d f ol l ow all sit e pr oce d ures a n d l ocal g ui deli nes f or meas ures i nte n de d t o 
pre ve nt C o vi d - 1 9 i nfecti o n.
P arti cip a nts s h o uld n ot e n ga ge i n stre n u o us p h ysical e xercise or acti vit ies fr om 4 8 h o urs pri or t o
d osi n g u nt il disc har ge fr o m t he st u d y or c o m pleti on of all st u d y  pr oce d ures. W he n certai n st u d y
pr oce d ures are i n pr o gress at t he site, partici pa nts ma y be re q uire d t o r e mai n s u pi ne or sitti n g .
5. 4.
Scree n F ail ures
Scree n fail ures are defi ne d as part ici 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 e nr olle d i n t he st u d y.
I n di vi d uals w h o f ulfill eli gi bility crit eria, b ut are n ot ra n d o mize d wit hi n t he 1 4 -d a y  scree ni n g 
wi n d o w, ma y st ill e nr oll i n t he st u d y pr o vide d ra n d o mizat i on occ urs wit hi n 2 8 da ys of t he first 
scree ni n g visit, a n d pr o vide d t hat t he y  re peat site pr oce d ures t o c o nfir m C o vi d - 1 9 stat us. T hese 
s u bjects d o n ot nee d t o be d oc u me nte d as scree n fail ures. S u bjects w h o are eli gi ble , b ut are n ot 
e nr o lle d wit hi n 2 8 da ys of t heir i nit ial scree ni n g visit, will nee d t o f oll o w re- scree n pr oce d ures 
descri be d bel o w.
F or t he p ur p oses of assessi n g eli gi bilit y,  scree ni n g c li nical la borat or y tests ma y be re peate d if t he 
res ult is c o nsi dere d li kel y d ue t o a tec h nical or ha n dli n g err or .


CONFIDENTIAL
J2Z-MC-PGAB
24
Individuals who do not meet the criteria for participation in this study (screen failure) due to a 
transient minor illness or concomitant medication may be re-screened if and when they later 
meet eligibility criteria.
Re-screened participants should be assigned a new screening number. When re-screening, all
screening tests and procedures should be repeated (except safety laboratory analyses, if 
randomization is to occur within 28 days of the first screening tests). Individuals may be re-
screened once, and must sign a new ICF.


C O N FI D E N TI A L
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2 5
6.
St u d y I nter ve nti o n
T he st u d y  int er ve nt i on will be gi ve n i n t he C R U b y q ualifie d C R U pers o n nel as desi g nate d b y  
t he i n vest i gat or. St u d y i njecti ons s h o ul d be gi ve n b y a li mite d n u m ber of pers o n nel f or 
c o nsiste nc y.
I njecti o n site
I njecti on site selecte d f or S C a d mi nistrati o n s h o ul d be t he a b d o mi nal re gi o n a p pr o xi matel y 5 c m 
fr om t he u m bilic us ; a n d t he treat me nt has t o be a d mi nistere d t hr o u g h t he nee dle a p plie d at 
a p pr o xi matel y 4 5° wit h pi nc hi n g of t he s ki n.
P arti cipa nts will recei ve mul tiple i nject i ons per d ose, eac h i nject i on s h o ul d be a d mi nistere d i n a 
differe nt a b d o mi nal q ua dra nt (r otati n g f or i nsta nce fr om rig ht u p per q ua dra nt, t o ri g ht l o wer 
q ua dra nt, t o left l o wer q ua dra nt, a n d t o left u p per q ua dra nt); t he q ua dra nt use d s h o ul d be 
rec or de d at t he ti me of t he i njecti o n.
All i njectio ns s h o ul d be perf or m e d wit hi n a t otal of 1 0 mi n utes ma xi m u m . Eac h i njecti o n is 
f oll owe d b y a n assess me nt of t he i nject i on site , as descri be d i n Secti o n 8. 2. 5 .
T he sa me t y p e of  s yrin ge a n d ne e dle s h o uld be use d f or all s u bjects t o e ns ure all i nject i ons are 
deli vere d t o a c o nsiste nt de pt h tar get i nt o t he S C s pace.
6. 1.
St u d y I nter ve nti o ns A d mi nistere d
I nter ve nti o n
L Y 3 8 3 2 4 7 9 
Pl ace b o
T y pe 
Bi ol o gic
N ot a p plica ble
D ose F or m ul ati o n
s ol uti o n
0. 9 % so di u m c hl ori de s ol uti o n
U nit D ose Stre n gt h(s)
2 6 2. 5 m g/ 2. 1 m L vial ( 1 2 5 m g/ m L)
Place b o
Pl a n ne d D os a ge Le vel(s)
C o h ort 1 : 3 5 0 m g
C o h o rt 2: 1 0 0 0 m g
N ot a p plica ble
R o ute of A d mi nistr ati o n
S C i njecti o n
S C i njecti o n
Use
e x peri me ntal
place b o
I M P a n d NI M P
I M P
I M P
S o urci n g
F r om Lill y
C o m merciall y a vaila ble 0. 9 % s o di u m 
c hl ori de s ol uti o n
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 a n d will be la bele d 
a p pr o priatel y
C o m merciall y a vaila ble 0. 9 % s o di u m 
c hl ori de s ol uti o n will be use d as a 
place b o f or t his st u d y


CONFIDENTIAL
J2Z-MC-PGAB
26
Abbreviations: IMP = investigational medicinal product; NIMP = non-investigational medicinal product; 
SC = subcutaneous.


CONFIDENTIAL
J2Z-MC-PGAB
27
6.1.1.
Injection Volumes and Formulation Concentrations
Injection volumes are as follows:
Cohort (LY3832479 dose)
Number of injections and volumes
Cohort 1 (350 mg)
2x 1.4 mL
Cohort 2 (1000 mg)
4x 2.0 mL
The LY3832479 formulation concentration will be 125 mg/mL in all cases.
6.1.2.
In the Event of a Retrospective Positive Sterility Finding from Prepared Study
Intervention
If a positive sterility finding occurs in the terminally sterile filtered study intervention, the
participants who were dosed from the impacted batch should be contacted immediately and
undergo a full physical examination including, but not limited to, blood pressure, pulse rate, and
body temperature.
A blood sample should be collected for culture and assayed for inflammatory markers such as
C-reactive protein and elevations in white blood cell counts.
If the signs and symptoms indicated a participant has a possible infection, they will be clinically
managed, treated, and followed up until resolution. Any AEs will be recorded as appropriate.
6.2.
Preparation/Handling/Storage/Accountability
The investigator or designee must confirm appropriate temperature conditions have been 
maintained during transit for all study intervention received, and any discrepancies are reported 
and resolved before use of the study intervention.
To protect blinding, the interventions must be prepared by unblinded site personnel qualified to 
prepare study intervention who are not involved in any other study-related procedures.
Instructions for preparation will be provided by the sponsor.
Only participants enrolled in the study may receive study intervention, and only authorized site 
staff may supply or administer study intervention.
All study intervention must be stored in a secure, environmentally controlled, and monitored 
(manual or automated) area in accordance with the labeled storage conditions with access limited 
to the investigator and authorized site staff.
The investigator, institution, or the head of the medical institution (where applicable) is 
responsible for study intervention accountability, reconciliation, and record maintenance (i.e., 
receipt, reconciliation, and final disposition records).
Further guidance and information for the final disposition of unused study interventions are 
provided in the pharmacy manual.
6.3.
Measures to Minimize Bias: Randomization and Blinding
Randomization tables for allocation of either LY3832479 or placebo will be prepared by the 
statistician or his/her designee.


C O N FI D E N TI A L
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2 8
T his st u d y  will b e p artici pa nt - a n d i n vest i gat or-bli n d.
Bli n di n g will be mai ntai ne d t hr o u g h o ut t he c o n d uct of t he st u d y  as descri be d i n t he se parate 
Bli n di n g Pla n.
E mer ge nc y  c o des will be a vaila ble t o t he i n vest i gat or. A c o de, w hic h re veals t he treat me nt gr o u p 
f or a s pecific st u d y s u bject, ma y be o pe ne d d uri n g t he st u d y o nl y if t he s u bject’s well-bei n g 
re q uires k n o wle d ge of t he s u bject’s treat me nt assi g n me nt.
I n case of a n e mer ge ncy,  t he i n vesti gat or has t he s ole res p o nsi bility f or deter mi ni n g if u n bli n di n g 
of  a s u bject’s treat me nt assig n m e nt i s warra nte d f or me dical ma na ge me nt of t he e ve nt. T he 
s u bject’s safety 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 nat i on. If t he 
i n vesti gat or deci des t hat u n bli n di n g is warra nte d, it is t he res p o nsi bility of  t he i n vestigat or t o 
pr o m ptl y d oc u m e nt t he decisi o n a n d rati o nale a n d n otif y Lill y as s o o n as p ossi ble.
If a n i n vesti gat or, site pers o n nel perf or mi n g assess me nts, or partici pa nt is u n bli n de d d uri n g 
d osi n g , t he partici pa nt must be wi t hdra w n fr o m  furt her st u d y  int er ve nt i on . If a n y a mo u nt of  
st u d y int er ve ntio n was a d mi nistere d, f oll o w pr oce d ures acc or di n g t o t he S o A , as descri be d i n 
Secti o n 7. 1 .
U p o n c o m plet i on of t he st u d y , all c o des must be ret ur ne d t o Lill y  or its desi g nee.
6. 4.
St u d y I nter ve nti o n C o m pli a nce
P articipa nts will recei ve st u d y  int er ve nt i on di rectl y fr om t he i n vesti gat or or desi g nee, u n der 
me dical s u per visi o n. T he date a n d ti me of d os i n g i n t he cli nic will be rec or de d i n t he s o urce 
d oc u m e nts a n d i n t he C R F. T he d ose of st u d y  int er ve nt i on a n d st u d y  p artici pa nt ide nt ificati on 
will be c o nfir me d at t he ti me of d os i n g b y a me m ber of t he st u d y site pers o n nel ot h er t ha n t he 
pers o n a d mi nisteri n g t he st u d y  int er ve nt i on.
6. 5.
C o nc o mit a nt T her a p y
All c o nc o mit a nt me dicat i on s, w het her prescri pt i on or o ver t he c o u nter, use d at baseli ne a n d/ or 
d uri n g t he c o urse of t he trial, m ust be rec or de d o n t he C o nc o mita nt Me dicat i on e C R F.
P arti cipa nts will be i nstr ucte d t o c o ns ult t he i n vest i gat or or ot her a p pr o priate st u d y pers o n nel at 
t he st u d y sit e b ef ore ta ki n g a n y ne w me d icati ons or s u p ple me nts d uri n g t he st u d y .
I n ge neral, c o nc o mita nt medicat i on s h o ul d be a v o i de d. Use of c hr o nic, sta ble d oses of h or m o ne 
r e place me nt t hera p y, t h yr oid r e pl ace me nt me dicati o ns, or vita mi n a n d mi neral s u p ple me nts is 
all o we d.
Aceta mi n o p he n ( 1 g, ma xi m u m 3 g/ 2 4 h o urs) ma y be a d mi nistere d at t he discreti o n of t he 
i n vesti gat or f or treat me nt of hea dac he, etc. H o we ver, aceta mi n o p he n ma y n ot be gi ve n wit hi n 
2 4 h o urs bef ore d osi n g.
If t he nee d f or c o nc o mita nt me dicati on ( ot her t ha n aceta mi n o p he n) arises, i ncl usi o n or 
c o nti n uat i on of t he partici pa nt ma y be at t he discret i on of t he i n vesti gat or after c o ns ultati o n wit h 
a Lill y cli nical p har mac olo gi st or C R P.
A n y me dicat i on use d d uri n g t he c o urse of t he st u d y m ust be d oc u me nte d.
All vacci nes are pr o hi bite d u nt il st u d y c o mpleti o n.


C O N FI D E N TI A L
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6. 6.
D ose M o dific ati o n
De pe n di n g o n t he res ults of a gi ve n trial- le vel s af et y re vie w, t he d ose of t he s u bse q ue nt c o h ort 
ma y be a dj uste d. Beca use t hese a dj ust me nts t o d ose le vels are all o wa ble c ha n ges per mitte d b y 
t he pr ot oc ol, t he y w o uld n ot re q ui re a pr ot oc ol a me n d me nt.
6. 6. 1.
D ose -Es c al ati o n Criteri a
D ata will be e val uate d o n a n o n g oi n g basis.
After at l east 5 partici pa nts assi g ne d t o L Y 3 8 3 2 4 7 9 ha ve c o m plete d Da y  4 i n a gi ve n c o h ort, all 
safety data a vaila ble u p t o t his c ut off date (A Es a n d vital si g ns) will be re vie we d t o deter mi ne 
w het her t he ne xt c o h ort ca n be ra n d o mize d after a gree me nt bet wee n Lill y’s me dical m o nit or a n d 
t he i n vest i gat or. Safety a n d t olera bilit y data will be t he pri mar y criteria g uidi n g d ose escalati o n.
T he i n vest i gat or a n d t he Lill y s p o ns or tea m are res p o nsi ble for deter mi ni n g a n y  d ose decisio ns. 
T he i n vest i gat or(s) will re mai n bli n de d a n d t he Lill y s p o ns or tea m will be u n bli n de d d uri n g t hese 
re vie ws. All a vaila ble data fr o m C o h ort 1 will be re vie we d. De pe n di n g o n t he res ults of t he 
safety e val uat i on, t he d ose o f C o h ort 2 m a y p ote ntiall y  be decrease d, b ut n ot i ncrease d be y o n d 
t he pla n ne d ma xi m u m d ose of 1 0 0 0 m g.
If te mp orar y  st o p pi n g crit eria are met ( Sectio n 6. 6. 3 ), d osi n g will be te m p oraril y halte d a n d n o 
f urt her partici pa nts will be d ose d u ntil a f ull safet y re vie w of t he st u d y has ta ke n place.
6. 6. 2.
Access t o D at a d uri n g t he St u d y
A li mite d n u m ber of u n bli n de d Lill y st u d y tea m pers o n nel will ha ve access t o safety a n d/ or P K 
data d uri n g t he st u d y .
6. 6. 3.
Te m p or ar y St o p pi n g Criteri a
D osi n g will be te m p oraril y halte d, a n d n o f urt her partici pa nts will be d ose d u nt il safety data 
a vaila ble at t hat p oi nt ha ve bee n re vie we d :

3 or m ore parti ci pa nts de vel o p A Es t hat are gra de d as a t least mo derate, c o nsi dere d 
r elate d t o st u d y tr e at me nt , cli nicall y si g nifica nt, a n d n ot res p o nsi ve t o s u p p orti ve care.

if 1 or m ore parti ci pa nts de vel o p A Es relate d t o st u d y treat me nt a n d t hat are serio us 
( S A Es) or gra de d as se vere.
T his ta ble descri bes t he lo c ati o n of  AE- r elate d i nf o r mat i on i n t his pr ot oc ol.
T o pic
L oc ati o n
Defi niti o n of A Es
Secti o n 1 0. 3. 1
Assess me nt of I nte nsit y/ Se verit y
Secti o n 1 0. 3. 3
C ha n ges t o t he pla n ne d d osi n g sc he d ule m ust be a p pr o priatel y d oc u me nte d a n d c o m m u nicate d 
wi t h t he st u d y pers o n nel a n d t he IR B/I E C bef ore d osi n g c o nt i n ues.
6. 7.
I nter ve nti o n A fter t he E n d of t he St u d y
N ot a p plica ble.


C O N FI D E N TI A L
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7.
Disc o nti n u ati o n of St u d y I nter ve nti o n a n d P artici p a nt 
Disc o nti n u ati o n/ Wit h dr a w al
T hese secti o ns descri be reas o ns f or a partici pa nt’s

p er m a ne nt or te mp orar y  disc o nti n uati on of st u d y  int er ve nt i on , or

di sc o nti n uati on ( wi t hdra wal) fr o m  t he st u d y.
Di sc o nti n uatio n of  t he trial as a w h ole is ha n dle d as part of re g ulat or y , et hical, a n d trial o versi g ht 
c o nsi derati o ns i n A p pe n di x 1 (Secti o n 1 0. 1 ).
7. 1.
Disc o nti n u ati o n of St u d y I nter ve nti o n
N o t a p plica ble.
7. 2.
P artici p a nt Disc o nti n u ati o n/ Wit h dr a w al fr 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 his/ her o w n re q uest
●
at t he re q uest of his/ her desi g nee (f or e xa m ple, pare nts or le gal g uar dia n)
●
at t he discreti o n of t he i n vest i gat or f or safety,  be ha vior al , c o mplia nce, or 
a d mi nistrati ve reas o ns
●
if t he partici pa nt bec ome s pre g na nt d uri n g t he st u d y, or
●
if e nr oll me nt i n a n y ot her cli nical st u d y in v o l vi n g a n i n vesti gati onal pr o d uct or 
e nr o ll me nt i n a n y ot her t y pe of me d ical researc h j u d ge d n ot t o be scie ntificall y or 
me dicall y c o m pat i ble wit h t his st u d y
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 nt i n uati on visit s h o ul d be 
c o n d ucte d, as s h o w n i n t he S o A. See S o A f or data t o be c ollecte d at t he ti me of st u d y  
di sc o nti n uati on a n d f o ll ow- u p a n d f or a n y  furt her e val uat i ons t hat nee d t o be c o m plete d . T he 
parti ci pa nt will be per ma ne nt l y disc o nti n ue d b oth fr o m t he st u d y i nter ve nt i on a n d fr o m t he st u d y 
at t hat ti me.
If t he partici pa nt wit h dra ws c o nse nt f or discl os ure of f ut ure i nf or mati on, t he s p o ns or ma y  retai n 
a n d c o nt i n ue t o use a n y data c ollecte d bef ore s uc h a wit h dra wal of c o nse nt. If a partici pa nt 
wi t hdra ws fr o m t he st u d y, he/s he ma y re q uest destr uctio n of  a n y sa mples ta ke n a n d n ot teste d, 
a n d t he i n vest i gat or m ust d oc u me nt t his i n t he site st u d y rec or ds.
7. 2. 1.
Disc o nti n u a ti o n of I n a d verte ntl y E nr olle d P artici p a nts
If t he s p o ns or or i n vesti gat or i de ntifies a partici pa nt w h o did n ot m eet e nr oll me nt criteria a n d 
was i na d verte ntl y e nr olle d, t his parti ci pa nt will c o m plete safety f oll ow- u p as o utli ne d i n

Secti o n 1. 3 ( S o A)

Secti o n 8. 2 (Safet y Assess me nts), a n d

Secti o n 8. 3 ( A d verse E ve nts a n d Seri o us A d verse E ve nts).


CONFIDENTIAL
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7.3.
Lost to Follow-up
A participant will be considered lost to follow-up if he or she repeatedly fails to return for 
scheduled visits and is unable to be contacted by the study site. Site personnel are expected to 
make diligent attempts to contact participants who fail to return for a scheduled visit or were 
otherwise unable to be followed up by the site.


C O N FI D E N TI A L
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8.
St u d y Assess me nts a n d 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 ( Sectio n 1. 3 ).
I mme diate safet y c o ncer ns s h o ul d be disc usse d wit h t he s p o ns or i m me diatel y u p o n occ urre nce or 
a ware ness t o deter mi ne if t he partici pa nt s h o ul d c o nt i n ue or disc o nti n ue st u d y int er ve nt i on.
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 ons m u st be c o mplete d a n d re vie we d t o c o nfir m t hat p ote ntial part ici pa nts 
meet all eli gi bilit y criteria. T he i n vesti gat or or desi g nee will  mai ntai n a scree ni n g l o g t o rec or d 
details o f all partici pa nts scree ne d a n d t o c o nfir m eli gi bilit y or rec or d reas o ns f or scree ni n g 
fail ure, as a p plica ble.
8. 1.
Effic ac y Assess me nts
N ot a p plica ble.
8. 2.
S afet y Assess me nts
Pl a 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.
8. 2. 1.
P h ysic al E x a mi n ati o ns
A c o m p lete p h ysical e xa mi nati on will i ncl u de, at a mi ni m u m, assess me nts of t he car dio vasc ular, 
res pir at or y, gastr oi ntesti nal , der mat ol o gi cal, a n d ne ur olo gi cal s yste ms. Heig 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.
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 C O VI D - 1 9.
8. 2. 2.
Vit al Si g ns
F or eac h parti ci pa nt, vit al si gn meas ure me nts s h o ul d be c o n d ucte d acc or di n g t o t he S o A
( Sectio n 1. 3 ). A d diti onal vital si g ns ma y be meas ure d d uri n g eac h st u d y  p erio d at t he 
i n vesti gat or’s j u d g me nt. Bl o o d press ure a n d p ulse rate s h o uld be meas ure d after at least 
5 mi n utes s u pi ne.
Ort h ostatic vital si g ns s h o ul d be assesse d, if p ossi ble, d uri n g a n y A E of dizzi ness or 
p ost ure -i n d uce d s y m pt o ms. If ort h ostatic meas ure me nts are re q uire d, parti ci pa nts s h o uld be 
s u pi ne f or at least 5 mi n utes a n d sta n d f or at least 3 mi n utes. If t he parti ci pa nt feels u na ble t o 
sta n d, s u pi ne vital si g ns o nl y will be rec or de d.
A d dit i onal vit al si g ns ma y be meas ure d d uri n g eac h st u d y p erio d , if warra nte d.
8. 2. 3.
Electr oc ar di o gr a ms
A si n gle, l ocal, 1 2 -lea d E C G will be o btai ne d as s h o w n i n t he S o A, usi n g a n E C G mac hi ne t hat 
a ut o mat icall y calc ulates t he heart rate a n d meas ures p ul se rate, Q R S, Q T, a n d c orrecte d Q T 
i nter vals. A d dit i onal E C G rea di n gs ma y occ ur at i n vestig at or di screti on.


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8. 2. 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 ( Secti o n 1 0. 2 ) f or t he list of cli nical la b orat or y tests t o be perf or me d a n d t o 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.
T he i n vest i 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  in t he A E secti o n of t he C R F. T he 
la b orat or y re p orts must be file d wit h t he s o urce d oc u me nts .
If la b orat or y val ues fr o m n o n pr ot oc ol -s pecifie d la b orat or y assess me nts perf or me d at t he 
i nstituti o n’s l o c al  la b orat or y r e q uire a c ha n ge i n partici pa nt ma na ge me nt or are c o nsi dere d 
cli nicall y si g nifica nt b y t he i n vestigat or ( f or e xa m ple, S A E, A E , or d ose m o dificat i on), t he n t he 
res ults must be rec or de d i n t he C R F.
8. 2. 5.
He p atic M o nit ori n g
Cl ose he p atic m o nit ori n g
I n case of he patic a b n or malit y, la b orat or y tests ( A p pe n di x 6, Secti o n 1 0. 6 ), i ncl u di n g A L T, A S T, 
A L P, T B L, D. Bil, G G T, a n d C K, s h o ul d be re peate d wit hi n 4 8 t o 7 2 h o urs t o c o nfir m t he 
a b n or malit y, a n d t o deter mi ne if it is i ncreasi n g or decreasi n g if 1 or m ore of t hese c o n dit i ons 
occ ur:
If a partici pa nt wit h baseli ne res ults of...
de vel o ps t he f oll o wi n g ele vati o ns:
A L T or A S T < 1. 5 x U L N
A L T or A S T ≥3 x U L N
A L P < 1. 5 x U L N
A L P ≥2 x U L N
T B L < 1. 5 x U L N
T B L ≥2 x U L N (e xce pt f or patie nts wit h Gil bert’s s y n dr o me)
A L T or A S T ≥1. 5 x U L N
A L T or A S T ≥2 x baseli ne
A L P ≥1. 5 x U L N
A L P ≥2 x baseli ne
T B L ≥1. 5 x U L N
T B L ≥2 x baseli ne (e xce pt f or patie nts wit h Gil bert’s s y n dr o me)
If t he a b n or mality persists or w orse ns, cli nical a n d la b orat or y  mo ni t ori n g a n d e val uati on f or 
p ossi ble ca uses of a b n or mal li ver tests s h o ul d be i nit iate d b y t he i n vesti gat or i n c o ns ultati on wi t h 
t he Lill y-desi g nate d m e dical m o nit or. At a mi ni m u m, t his e val uat i on s h o ul d i ncl u de p h ysical  
e xa mi nat i on a n d a t h or o u g h me dical hist or y , i ncl u di n g s y m pt o ms, rece nt ill nesses (f or e xa m ple, 
heart fail ure, s yste mic i nfect i on, h y p ote nsi o n, or seiz ures), rece nt tra vel, hist or y  of c o nc o mit a nt 
me dicat i ons (i ncl u di n g o ver -t he- c o u nter), her bal a n d dietar y s u p ple me nts, hist or y of alc o h o l 
dri n ki n g , a n d ot her s u bsta nce a b use.
I nitiall y, mo ni t ori n g of s y m pt o ms a n d he patic bi oc he mical tests s h o ul d be d o ne at a fre q ue nc y o f 
1 t o 3 ti mes wee kl y , base d o n t he partici pa nt’s cli nical c o n dit i on a n d he pat ic bi oc he mical tests. 
S u bse q ue ntl y, t he fre q ue nc y  of mo ni t orin g m a y be lo were d t o o nce e ver y  1 t o 2 wee ks, if t he 
parti ci pa nt’s cli nical c o n dit i on a n d l a b res ults sta bilize. M o nit ori n g of A L T, A S T, A L P, a n d 
T B L s h o ul d c o nt i n ue u ntil le vels n or malize or ret urn t o a p pr o xi mate baseli ne le vels.
C o m pre he nsi ve he p atic e v al u ati o n


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A c o m pre he nsi ve e val uat i on s h o ul d be perf or m e d t o searc h f or p ossi ble ca uses of li ver i nj ur y if 
1 or m ore of t hese c o n dit i ons occ ur:
If a partici pa nt wit h baseli ne res ults of...
de vel o ps t h e f oll o wi n g ele vati o ns:
A L T or A S T < 1. 5 x U L N
A L T or A S T ≥3 x U L N wit h he patic si g ns/s y m pt o ms *, or
A L T or A S T ≥5 x U L N
A L P < 1. 5 x U L N
A L P ≥3 x U L N
T B L < 1. 5 x U L N
T B L ≥2 x U L N (e xce pt f or patie nts wit h Gil bert’s s y n dr o me)
A L T or A S T ≥1. 5 x U L N
A L T or A S T ≥2 x baseli ne wit h he patic si g ns/s y m pt o ms *, or
A L T or A S T ≥3 x baseli ne
A L P ≥1. 5 x U L N
A L P ≥2 x baseli ne
T B L ≥1. 5 x U L N
T B L ≥1. 5 x baseli ne (e xce pt f or patie nts wit h Gil bert’s s y n dr o me)
* He patic si g ns/s y m pt o ms are se vere fati g ue, na usea, v o miti n g, ri g ht u p per q ua dra nt a b d o mi nal pai n, fe ver, ras h, 
a n d/ or e osi n o p hilia > 5 %.
At  a mi ni m u m, t his e val uati on s h o ul d i ncl u de p h ysical e xa mi nat i on a n d a t h or o u g h me dical 
hist or y , as o utli ne d a b o ve, as well as tests f or P T-I N R; tests f or viral he patitis A, B, C, or E; tests 
f or a ut oi m m u ne he patitis; a n d a n a b d o mi nal i ma gi n g st u d y (for e xa m ple, ul tras o u n d or C T sca n).
Base d o n t he patie nt’s hist or y  a n d i nitial res ults, furt her testi n g s h o ul d be c o nsi dere d i n 
c o ns ultati o n wit h t he Lill y -desi g nate d m e dical mo ni t or, incl u di n g tests f or H D V, C M V, E B V) 
aceta mi n o p he n le vels, aceta mi n o p he n pr otei n a d d ucts, uri ne t o xic o l og y  scree n, Wils o n’s disease, 
bl o o d alc o h o l levels, uri nar y  et h yl gl uc ur o ni de, a n d ser u m p h os p hati dylet ha n o l. Base d o n t he 
circ u msta nces a n d t he i n vesti gat or’s assess me nt of t he partici pa nt’s cli nical c o n diti on, t he 
i n vesti gat or s h o ul d c o nsi der referri n g t he partici pa nt f or a he pat ol o gist or gastr oe nter ol o gist 
c o ns ultati o n, ma g netic res o na nce c h o lan gi o pa ncreat o gra p h y , e n d osc o pic retr o gra de 
c h o lan gi o pa ncreat o g ra p h y, car diac ec h ocar dio gra m , or a li ver bio ps y.
A d diti o n al he p atic d at a c ollecti o n ( he p atic s afet y C R F) i n st u d y p artici p a nts w h o h a ve 
a b n or m al li ver tests d uri n g t he st u d y
A d dit i onal he patic safet y data c ollect i on i n he pat ic safety C R F s s h o uld be perf or me d i n st u d y  
parti ci pa nts w h o meet 1 or m ore of t he f o ll owi n g 5 c o n di tio ns:
1.
Ele vat i on of ser u m A L T t o ≥5 x U L N o n 2 or m ore c o nsec uti ve bl o o d tests (if baseli ne A L T 
< 1. 5 x U L N)

I n partici pa nts wit h baseli ne A L T ≥1. 5 x U L N, t he t hres h o l d is A L T ≥3 x baseli ne o n 2 
or m ore c o nsec uti ve tests
2.
Ele vate d T B L t o ≥2 x U L N (if baseli ne T B L < 1. 5 x U L N) (e xce pt f or cases of k n o w n 
Gil bert’s s y n dr o me)

I n partici pa nts wit h baseli ne T B L ≥1. 5 x U L N, t he t hres h o l d s h o ul d be T B L ≥2 x 
baseli ne
3.
Ele vat i on of ser u m A L P t o ≥2 x U L N o n 2 or m o re c o nsec uti ve bl o o d tests (if baseli ne 
A L P < 1. 5 x U L N)


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
I n partici pa nts wit h baseli ne A L P ≥1. 5 x U L N, t he t hres h o l d is A L P ≥2 x baseli ne o n 2 
or m ore c o nsec uti ve bl o o d tests
4.
He pati c e ve nt c o nsidere d t o be a n S A E
N ote: t he i nter val bet wee n t he 2 c o nsec uti ve bl o o d tests s h o ul d be at least 2 da ys.
8. 2. 6.
I njecti o n Site Re acti o n As sess me nt
I njecti on site assess me nts usi n g t he I S R C R F , V A S if re q uire d (see bel o w), a n d a n e x pl orat or y 
t o ol ( S c arletre d) will be perf or me d at ti mes s pecifie d i n t he S o A ( Secti o n 1. 3 ).
I njecti on site pai n assess me nts are part of t he s olicite d a n d s p o nta ne o us I S R assess me nts. T he 
baseli ne assess me nt, a n d a ll p ositi ve res p o nses of pai n fr om t he n o n, will re q uire a n a d dit i onal 
assess me nt usi n g t he Pai n V A S.
As t here are m ult i ple i njecti ons f or eac h d ose, I S R assess me nts will be d o ne f or eac h i njecti on.
Ma nifestati o ns of a l o c al  I S R ma y i ncl u de er yt he ma, i n d urat i on, pai n, pr urit us, a n d e de ma. 
I njecti on site fi n di n gs will be ca pt ure d o n t he e C R F.
I njecti on site reacti o ns, if rec or de d as a res ult of t he pres pecifie d ( or s olicite d) assess me nt, will 
be rec or de d as A Es o nl y  if t he y q ualif y as S A Es.
If a s p o nta ne o us ( or u ns olicite d) I S R is re p orte d b y a p artici pa nt or in vest i gat or, t he I S R C R F 
will be use d t o ca pt ure a d dit i onal i nf or mati on a b o ut t his reacti o n (f or e xa m ple, de gree a n d area 
of  er yt he ma) at a d ditio nal  visits u ntil res ol uti on o f t he e ve nt.
T he V A S is a we ll-vali date d t o ol ( Willia ms o n a n d H o g gart 2 0 0 5) t o assess i njecti o n site pai n; it 
is prese nte d as a 1 0 0-m m li ne a nc h ore d b y ver bal descri pt ors, us uall y “ n o pai n” a n d “ w orst 
i ma gi na ble pai n.” T he partici pa nt will be as ke d t o rate a n y pai n at t he i njecti on s ite o n a scale of 
0 t o 1 0 0 o n t he li ne , as s o o n as p ossi ble f oll owi n g eac h i njecti on.
I n a d diti on, t he e x pl orat or y  t o ol ( S c arletre d) will be use d t o ac q uire e x pl orat or y  I S R data at eac h 
of  t he ti me p oi nts w here t he I S R data is bei n g c ollecte d b y a d mi nistratio n of  t he I S R C R F . 
Fail ure t o ta ke t his assess me nt at a n y  of t he i n dicate d ti me p oi nts will n ot res ult i n a pr ot oc ol 
de viat i on.
8. 3.
A d verse E ve nts a n d Seri o us A d verse E ve nts
A d verse e ve nts will be re p orte d b y  t he partici pa nt.
T he i n vest i 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 on of a n A E or S A E a n d re mai n res p o nsi ble f or f o ll owi n g 
u p A Es t hat are seri o us, c o nsi dere d relate d t o t he st u d y  int er ve nt i on or st u d y  pr oce d ures, or t hat 
ca use d t he partici pa nt t o disc o nt i n ue t he st u d y int er ve nt i on or st u d y .
Di sc o nti n uatio n i nf or mat i on is i n Secti on 7 .
Detaile d A E defi nit i ons a n d pr oce d ures are i n Secti o n 1 0. 3 .


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8. 3. 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
All A Es a n d S A Es will be c ollecte d fr o m t he ti me of sig ni n g of  t he I C F u nt il part ici pati on i n t he 
st u d y has e n de d .
A d verse e ve nts t hat be gi n bef ore t he start of st u d y  int er ve nt i on, b ut after si g ni n g of t he I C F will 
be rec or de d o n t he A E C R F.
Alt h o u g h all A Es after si g ni n g t he I C F are rec or de d b y  t he site i n t he C R F/electr o nic data e ntr y, 
S A E re p orti n g t o s p o ns or be gi ns after t he partici pa nt has si g ne d t he I C F a n d has recei ve d st u d y  
i nter ve nt i on. H o we ver, if a n S A E occ urs after si g ni n g t he I C F, b ut pri or t o recei vi n g st u d y 
i nter ve nt i on , it nee ds t o be re p orte d wit hi n t he S A E re p orti n g t i me fra me if it is c o nsi dere d 
reas o na bl y p ossi bl y relate d t o st u d y pr oce d ures.
All S A Es will be rec or de d a n d re p orte d t o t he s p o ns or or desi g nee i m me diatel y a n d u n der n o 
circ u msta nce s h o uld t hi s e xcee d 2 4 h o urs, as i n dicate d i n Secti o n 1 0. 3 , 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 SA E data t o t he s p o ns or wit hi n 2 4 h o urs of it bei n g 
a vaila ble.
I n vesti gat ors are n ot o bli gate d t o acti vel y see k A Es or S A Es aft er c o nclusi o n  of t he st u d y 
parti ci pat i on ( D a y 8 5). 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 bee n dis c har ge d fr o m t he st u d y, a n d he/s he c o nsi ders t he e ve nt t o be 
reas o na bl y relate d t o t he st u d y int er ve nt i on or st u d y partici pat i on, t he i n vest i gat or m ust pr o m ptl y 
n otif y t he s p o ns or.
8. 3. 2.
Met h o d of Detecti n g A Es a n d S A Es
T he m et h o d of  rec or di n g, e val uati n g, a n d assessi n g ca usality of A E a n d S A E a n d t he pr oce d ures 
f or c o mplet i n g a n d tra ns mitti n g S A E re p orts are pr o vi de d i n Sect i on 1 0. 3 , A p pe n di x 3
Care will be ta ke n n ot t o i ntr o d uce bias w h ile 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. 3. 3.
F oll o w -u p of A Es a n d S A Es
After t he i nit ial A E/ 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 ow eac h partici pa nt 
at s u bse q ue nt visits/c o ntacts. All S A Es will be f o ll o we d u p u ntil res ol uti on, sta bilizat i on, 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 o ll ow- u p (as defi ne d i n Secti o n 7. 3 ). 
F urt her i nf or mat i on o n f o ll ow- u p pr oce d ures i s pr o vide d i n Sect i on 1 0. 3 , A p pe n di x 3 .
8. 3. 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 otificat i on b y t he i n vest i gat or t o t he s p o ns or of a n S A E is esse ntial s o t hat le g al 
o bli gat i ons a n d et hical res p o nsi bilit ies t o war d t he safety of  partici pa nts a n d t he safet y of  a st u d y 
i nter ve nt i on u n der cli nical i n vesti gat i on are m et.
T he s p o ns or has a le gal res p o nsi bilit y t o n otif y b ot h t he lo c al  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 int er ve nt i on u n der cli nical i n vesti gati o n. T he 
s p o ns or will c om p l y wit h c o u ntr y-s pecific re g ulat or y re q uire me nts relati n g t o safety re p ortin g t o 
t he re g ulat or y a ut h orit y, I R B/I E C, a n d i n vesti gat ors.


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A n i n vesti gat or w h o recei ves a n i n vest i gat or safet y re p ort descri bi n g an S A E or ot her s pecific 
safety i nf or mati on ( f or e xa m ple, s u m mar y or listi n g of S A Es) fr om t he s p o ns or will re vie w a n d 
t he n file it wit h t he I B, a n d will n otif y t he I R B/I E C, if a p pr o priate acc or di n g t o l ocal 
re q uire me nts.
8. 3. 5.
Pre g n a nc y
Details o f all pre g na ncies i n fe male partici pa nts a n d fe male part ners of male partici pa nts will be 
c ollecte d after t he start of st u d y int er ve nt i on a n d u nt il at least 5 mo nt hs after t he l ast d ose.
If a pre g na nc y is re p orte d, t he i n vestigat or s h o ul d i nf or m  t he s p o ns or wit hi n 2 4 h o urs of  lear ni n g 
of  t he pre g na nc y a nd s h o ul d f ol l ow t he pr oce d ures o utli ne d i n Sect i on 1 0. 4 , A p pe n di x 4 .
A b n or m al pre g na nc y o utc o mes ( f or e xa m ple, s p o nta ne o us a b orti o n, fetal deat h, still birt h, 
c o n ge nital a n o ma lies, ect o pic pre g na nc y) are c o nsi dere d S A Es.
8. 3. 6.
H y perse nsiti vit y Re acti o ns
Ma n y  dr u gs, b ut partic ularl y bi o l ogic a ge nts, carr y t he ris k of s yste mic h y perse nsit i vity 
reactio ns. If s uc h a reacti o n occ urs, a d dit i onal details descri bi n g eac h s y m pt o m s h o ul d be 
pr o vi de d t o t he s p o ns or i n t he H y perse nsi tivi t y/ A na p h ylactic/Inf usi o n- Relat e d Reacti o n C R F.
Si tes s h o uld ha ve a p pr o pri atel y trai ne d me dical pers o n nel a n d a p pr o priate me dical e q ui p me nt 
a vaila ble w he n st u d y p artici pa nts are recei vi n g i nter ve nt i on. It i s rec o m me n de d t hat partici pa nts 
w h o e x perie nce a s yste mic h y perse nsit i vity react i o n be treate d per nati o nal a n d i nter nati onal 
g ui da nce ( Lie ber ma n et al . 2 0 1 5; Si m o ns et al . 2 0 1 5).
I n t he case of ge neralize d urticaria or a na p h yla xis, a d diti onal bl o o d a n d uri ne sa m ples s h o ul d be 
c ollecte d as descri be d i n Secti o n 1 0. 7 , A p pe n di x 7 , “Rec o m me n de d La b orat or y  Testi n g f or 
H y perse nsi tivi t y E ve nts”. La b orat or y res ults are pr o vi de d t o t he s p o ns or via t he ce ntral 
la b orat or y.
8. 3. 7.
S A R S -C o V -2 I nfecti o n
Si te pr oce d ures f or partici pa nt ma na ge me nt will be f oll owe d i n t he e ve nt of a s us pecte d 
S A R S -C o V -2 i nfect i on d uri n g t he st u d y .
A nas o p har y n geal s wa b will be ta ke n o n Da y  1 a n d s hi p pe d t o t he s p o ns or. T his is f or researc h 
p ur p oses, s uc h as viral se q ue nci n g .
I n a d diti on, S A R S -C o V - 2 p oi nt -of -care tests ma y be perf or me d at s pecific t i me p oi nts d uri n g t he 
st u d y at t he discretio n of  t he i n vesti gat or. E ver y ti me s uc h a p oi nt-of -care test is perf or me d p ost 
baseli ne, a n a d dit i on al  nasal s wa b sa m ple ma y be c ollecte d i n parallel, f or researc h p ur p oses 
s uc h as viral se q ue nci n g. T his researc h s wa b sa m ple will be s hi p pe d t o t he s p o ns or o nl y if t he 
p oi nt -of -care test is p ositi ve. If t he p oi nt-of -care test is ne gati ve, t he researc h s wa b sa m ple 
s h o uld be discar de d.
8. 3. 8.
Pr o d uct C o m pl ai nts
A pr o d uct c o m plai nt is a n y writte n, electr o nic, or oral c o m m u nicat i on t hat alle ges deficie ncies 
r elate d t o t he i de ntit y,  q uality, d ura bilit y,  relia bility,  s afet y,  effecti ve ness, or perf or ma nce of a 
trial int er ve nt i on.


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T he s p o ns or c o llects pr o d uct c o m p lai nts o n st u d y i nter ve nti ons use d i n cli nical st u dies t o e ns ure 
t he safet y of  st u d y p artici pa nts, mo ni t or q uality, a n d t o facilitate pr ocess a n d pr o d uct 
i m pr o ve me nts.
P arti cip a nts will be i nstr ucte d t o c o ntact t he i n vest i gat or as s o o n as p ossi ble if t he y ha ve a 
c o mplai nt or pr o bl e m wit h t he st u d y int er ve nt i on s o t hat t he sit u atio n ca n be assesse d.
N O T E: A n y A Es or S A Es t hat are ass ociate d wit h a pr o d uct c o m plai nt will f o ll ow t he pr ocesses 
o utli ne d i n Sect i on 8. 3. 3 a n d Secti o n 1 0. 3 , A p pe n di x 3, of  t he pr ot oc ol.
Ti me Peri o d f or Detecti n g Pr o d uct C o m pl ai nts
Pr o d uct c o m plai nts t hat res ult i n a n A E will be detecte d, d oc u me nte d, a n d re p orte d t o t he 
s p o ns or d uri n g all peri o ds of  t he st u d y in w hic h t he st u d y int er ve nt i on is use d.
If t he i n vestigat or l ear ns of a n y pr o d uct c o m plai nt at a n y ti me after a partici pa nt has bee n 
di sc har ge d fr o m t he st u d y, a n d s uc h i nci de nt is c o nsi dere d reas o na bl y relate d t o t he st u d y 
i nter ve nt i on , t he i n vesti gat or will pr o m ptl y n otif y t he s p o ns or.
Pr o m pt Re p orti n g of Pr o d uct C o m pl ai nts t o S p o ns or
Pr o d uct c o m plai nts will  be re p orte d t o t he s p o ns or wit hi n 2 4 h o urs aft er t he i n vest i gat or bec o mes 
a ware of t he c o m plai nt .
T he Pr o d uct C o m plai nt F or m  will be se nt t o t he s p o ns or b y a met h o d desig nate d b y  t he s p o ns or.
F oll o w -u p of Pr o d uct C o m pl ai nts
F o ll ow- u p a p plies t o all partici pa nts, i ncl u di n g t h ose w h o disc o nt i n ue st u d y int er ve nt i on.
T he i n vest i gat or is res p o nsi ble f or e ns uri n g t hat f oll o w-u p i ncl u des a n y s u p ple me ntal 
i n vesti gati ons as i n dicate d t o el uci date t he nat ure a n d/ or ca usalit y of  t he pr o d uct c o m plai nt .
Ne w or u p date d i nf or mat i on will be rec or de d o n t he ori gi nall y c o m p lete d f or m with all c ha n ges 
sig ne d a n d date d b y t he i n vest i gat or a n d su b mitte d t o t he s p o ns or .
8. 4.
Tre at me nt of O ver d ose
F or t he p ur p oses of t his st u d y , a n o ver d ose of L Y 3 8 3 2 4 7 9 is c o nsi dere d a n y d ose hi g her t ha n t he 
d ose assi g ne d t hr o u g h ra n d o mizat i on. I n case of s us pecte d o ver d ose, partici pa nts s h o ul d be 
m o nit ore d f or a n y  si g ns or s y m pt o ms of a d verse reacti o ns or effects, a n d s u p p orti ve care s h o ul d 
be pr o vi de d as necessar y .
8. 5.
P h ar m ac o ki netics
Ve n o us bl o o d sa mples will  be c ollecte d as s pecifie d i n t he S o A f or deter mi nati o n of  s er u m 
c o nce ntrati o ns of  L Y 3 8 3 2 4 7 9 use d t o e val uate t he P K f or L Y 3 8 3 2 4 7 9.
A ma xi m u m of 5 sa m ples ma y be c ollecte d at a d diti o nal t i me p oi nts d uri n g t he st u d y, if 
warra nte d a n d a gree d u p o n bet wee n t he i n vest i gat or a n d t he s p o ns or.
I nstr uctio ns f or t he c ollect i on a n d ha n dli n g of bi o l o gical sa mples will  b e pr o vide d b y Lill y .
Si te pers o n nel will rec or d

the date a n d ti me ( 2 4-h o ur cl oc k ti me) of  i n vesti gati o nal dr u g a d mi nistrati o n, a n d


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
the date a n d ti me ( 2 4 -h o ur cl oc k ti me) of eac h P K  sa m ple.
It is esse ntial t hat t he ti mes are rec or de d acc uratel y.
8. 5. 1.
Bi o a n al ytic al
S a m ples will  be a nal yze d at a la b orat or y a p pr o ve d b y t he s p o ns or a n d st ore d at a facility 
desi g nate d b y  t he s p o ns or. C o nce ntrati o ns of L Y 3 8 3 2 4 7 9 will be assa ye d usi n g a vali date d 
bi oa nal yt ical met h o d. A nal yses of sa m ples c ollecte d fr o m pl ace b o -treate d s u bjects are n ot 
pl a n ne d.
S a m ple rete nti o n is descri be d i n A p pe n di x 1, Secti o n 1 0. 1. 1 0 . Re m ai ni n g sa m ples use d f or P K 
ma y be p o ole d a n d use d f or e x pl orat or y  bioa nal y ti c al met h o d e x peri me nts as dee me d 
a p pr o priate.
8. 6.
P h ar m ac o d y n a mics
P har mac o d y na mic para meters will n ot be e val uate d i n t his st u d y.
8. 7.
Ge netics
A w h o le bl o o d sa m ple will be c ollecte d f or p har mac o ge netic a nal ysis w here l ocal re g ulatio ns 
all o w.
See Secti o n 1 0. 2 , Cli nical La b orat or y Tests, a n d Secti o n 1. 3 S o A f or sa m ple c o llecti on 
i nf or mat i on.
See Secti o n 1 0. 5 f or ge netic researc h, c ust o d y, a n d sa mple rete ntio n i nf or mat i on.
8. 8.
Bi o m ar kers
S er u m  sa m ples f or e x pl orat or y bio m ar ker researc h will be c o llecte d at t he ti me s pecifie d i n t he 
S o A w here l ocal re g ulati o ns all o w.
S a mples will  be st ore d a n d a nal ysis ma y be perf or me d o n bi omar ker s t ho u g ht t o pl a y a r ole i n 
i m m u ne s yste m-relate d res p o nses t o viral i nfecti o n or a d mi nistrati o n o f L Y 3 8 3 2 4 7 9 i nclu di n g, 
b ut n ot li mite d t o , i m m u ne pat h wa ys or ser u m a nal ytes t o e val uate t heir ass ociati on wi t h
L Y 3 8 3 2 4 7 9 a d mi nistrati o n.
S a mples ma y  be use d f or researc h t o de vel o p met h o ds, assa ys, pr o g n ostics , a n d/ or c o m pa ni o n 
di a g n ostics r elate d t o t he i nter ve nti o n target ( s pi ke pr otei n), pat h wa ys ass ociate d wit h disease, 
a n d/ or t he mec ha nis m o f actio n of  t he st u d y int er ve nt i on.
S wa b sa m ple s ta ke n d uri n g t he st u d y ma y be use d f or researc h p ur p oses, s uc h as viral 
se q ue nci n g.
S a m ple rete nti o n is descri be d i n Sect i on 1 0. 1. 1 0 .
8. 9.
I m m u n o ge nicit y Assess me nts
Visits a n d ti mes


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A t t he visit s a n d ti mes s pecifie d i n t he S o A , pre d ose v e n o us blo o d s a m ples will  be c ollecte d t o 
d eter mi ne a nti b o d y pr o d u ctio n a gai nst L Y 3 8 3 2 4 7 9. 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 c ollecti o n will be rec or de d. T o ai d i nter pretati o n o f t hese res ults, t he 
i m m u n o ge nicity sa m pli n g time p o i nts all c o i nci de wit h a P K sa m pli n g ti mep oi nt .
S a m ple c ollecti o n, h a n dli n g, a n d use
I nstr uctio ns f or t he c ollect i on a n d ha n dli n g of bl o o d sa m ples will be pr o vi de d b y t he s p o ns or.
I mm u n o ge nicit y will  be assesse d usi n g a vali date d assa y desi g ne d t o detect A D As i n t he 
prese nce of L Y 3 8 3 2 4 7 9 at a lab orat or y  a p pr o ve d b y t he s p o ns or. A nt i b o dies ma y be f urt her 
c haracterize d f or t heir a bilit y t o ne utralize t he acti vity of  L Y 3 8 3 2 4 7 9.
S a m ple rete nti o n
S a m ple rete nti o n is descri be d i n Sect i on 1 0. 1. 1 0 .
8. 1 0.
He alt h Ec o n o mic s
N ot a p plica ble.


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9.
Statistical Considerations
9.1.
Statistical Hypotheses
Formal statistical hypothesis testing is not planned. Therefore, adjustments for multiple testing 
do not apply.
9.2.
Sample Size Determination
A maximum of 22 participants will be enrolled to study intervention with the intention that at 
least 6 participants randomized to LY3832479 have sufficient evaluable data in each cohort.
The sample size is not powered on the basis of statistical hypothesis testing. However, based on 
an assumption of 40% CV for between subject variability in a PK parameter of interest, 
6 subjects on active treatment per cohort may provide approximately 70% chance to ensure that a 
PK parameter’s 90% confidence interval falls within (0.7, 1.43) over the corresponding 
geometric mean, such as AUC(0-∞).
A participant will be considered evaluable when the participant completes up to 57 days of study 
procedures. When a participant does not complete up to 57 days of study procedures, the sponsor 
will be consulted if the participant will need to be replaced.
9.3.
Populations for Analyses
The following populations are defined:
Population
Description
Entered
All participants who sign the ICF.
Enrolled/Intent-to-Treat
All participants randomized to study intervention, regardless of 
whether they received study treatment, or if they took the correct 
treatment. Participants will be analyzed according to the 
treatment group to which they were assigned.
Safety
All participants randomly randomized to study intervention and 
who received study intervention. Participants will be analyzed 
according to the intervention they actually received.
Pharmacokinetic Analysis
All randomized participants who received study intervention and 
have sufficient evaluable PK samples.
Abbreviations: ICF = informed consent form; PK = pharmacokinetic.
9.4.
Statistical Analyses
Statistical analysis of this study will be the responsibility of sponsor or its designee.
All tests of treatment effects will be conducted at a 2-sided alpha level of 0.1, unless otherwise 
stated, and all confidence intervals will be given at a 2-sided 90% level.
Any change to the data analysis methods described in the protocol will require an amendment 
only if it changes a principal feature of the protocol. Any other change to the data analysis 


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methods described in the protocol, and the justification for making the change, will be described 
in the SAP and the clinical study report. Additional exploratory analyses of the data will be 
conducted as deemed appropriate.
The SAP will be finalized prior to unblinding and it will include a more technical and detailed 
description of the statistical analyses described in this section. This section is a summary of the 
planned statistical analyses of the most important endpoints including primary and key secondary 
endpoints.
9.4.1. General Considerations
Statistical analyses will be performed using SAS® Version 9.4 or higher.
For continuous measures, summary statistics will include sample size, mean, standard deviation, 
minimum, median, and maximum. For categorical measures, summary statistics will include the 
sample size, frequency count, and percentage.
For all safety analyses, baseline will be defined as the last evaluable value up to dosing.
9.4.2.
Primary Endpoint: Pharmacokinetics
Pharmacokinetic parameter estimates for LY3832479 will be calculated by standard 
noncompartmental methods of analysis.
The primary parameters for analysis will be AUC(0-∞) and Cmax of LY3832479 following SC 
administration. Other noncompartmental parameters, such as half-life, tmax, apparent clearance, 
and volume of distribution following SC administration may be reported.
In addition to noncompartmental analysis, the data may be combined with data from other 
studies to be analyzed using non-linear mixed-effect modelling of the PK data. This model will 
enable estimation of mean and variability (variances) of LY3832479 PK parameters, including 
bioavailability, following SC administration and to investigate potential covariates explaining 
that variability.
9.4.3.
Secondary Endpoint: Safety
9.4.3.1.
Clinical Evaluation of Safety
All investigational product and protocol procedure AEs will be listed, and if the frequency of 
events allows, safety data will be summarized using descriptive methodology.
The incidence of AEs for each treatment will be presented by severity and by association with 
investigational product as perceived by the investigator. Adverse events reported to occur prior 
to randomization will be distinguished from those reported as new or increased in severity during 
the study. Each AE will be classified by the most suitable term from the medical regulatory 
dictionary.
All SAEs will be reported.


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9.4.3.2.
Statistical Evaluation of Safety
Safety parameters that will be assessed include safety laboratory parameters and vital sign
measurements. The parameters will be listed, and summarized using standard descriptive 
statistics. Additional analysis will be performed if warranted upon review of the data.
9.4.4.
Exploratory Endpoint: Injection Site Reaction Assessments
Injection site reactions will be listed and may be summarized by dose if data warrant.
9.5.
Interim Analyses
No interim analyses are planned for this study. If an unplanned interim analysis is deemed 
necessary, the Lilly CP, CRP/investigator, or designee will consult with the appropriate medical 
director or designee to determine if it is necessary to amend the protocol.
9.6.
Data Monitoring Committee (DMC)
Not applicable.


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10.
Supporting Documentation and Operational Considerations
10.1.
Appendix 1: Regulatory, Ethical, and Study Oversight 
Considerations
10.1.1.
Regulatory and Ethical Considerations
This study will be conducted in accordance with the protocol and with the following:

Consensus ethical principles derived from international guidelines including the 
Declaration of Helsinki and Council for International Organizations of Medical Sciences 
International Ethical Guidelines

Applicable ICH GCP Guidelines, and

Applicable laws and regulations.
The protocol, protocol amendments, ICF, IB, and other relevant documents (for example, 
advertisements) must be submitted to an IRB/IEC by the investigator and reviewed and approved 
by the IRB/IEC before the study is initiated.
Any amendments to the protocol will require IRB/IEC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants.
The investigator will be responsible for the following:

Providing written summaries of the status of the study to the IRB/IEC annually or more 
frequently in accordance with the requirements, policies, and procedures established by 
the IRB/IEC

Notifying the IRB/IEC of SAEs or other significant safety findings as required by 
IRB/IEC procedures, and

Providing oversight of the conduct of the study at the site and adherence to requirements 
of 21 CFR, ICH guidelines, the IRB/IEC, and all other applicable local regulations.
Study sites are compensated for participation in the study as detailed in the clinical trial 
agreement.
10.1.2.
Informed Consent Process
The investigator or their representative will explain the nature of the study, including the risks 
and benefits, to the participant or their legally authorized representative and answer all questions 
regarding the study.
Participants must be informed that their participation is voluntary. Participants or their legally 
authorized representative will be required to sign a statement of informed consent that meets the 
requirements of 21 CFR 50, local regulations, ICH guidelines, Health Insurance Portability and 
Accountability Act requirements, where applicable, and the IRB/IEC or study center.
The medical record must include a statement that written informed consent was obtained before 
the participant was entered in the study and the date the written consent was obtained. The 


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authorized person obtaining the informed consent and, if applicable, the individual designated to 
witness a verbal consent, must also sign the ICF.
Participants must be re-consented to the most current version of the ICF(s) during their 
participation in the study.
A copy of the ICF(s) must be provided to the participant or the participant’s legally authorized 
representative and is kept on file.
10.1.3.
Data Protection
Participants will be assigned a unique identifier by the sponsor. Any participant records, datasets
or tissue samples that are transferred to the sponsor will contain the identifier only; participant 
names or any information that would make the participant identifiable will not be transferred.
The participant must be informed that their personal study-related data will be used by the 
sponsor in accordance with local data protection law. The level of disclosure must also be 
explained to the participant who will be required to give consent for their data to be used as 
described in the informed consent.
The participant must be informed that their medical records may be examined by Clinical 
Quality Assurance auditors or other authorized personnel appointed by the sponsor, by 
appropriate IRB/IEC members, and by inspectors from regulatory authorities.
The sponsor has processes in place to ensure data protection, information security, and data 
integrity. These processes include appropriate contingency plan(s) for appropriate and timely 
response in the event of a data security breach.
10.1.4.
Dissemination of Clinical Study Data
A clinical study report will be provided for this study and a summary of study information 
provided on publicly available websites.
10.1.5.
Data Quality Assurance
Investigator responsibilities
All participant data relating to the study will be recorded on printed or electronic CRF unless 
transmitted to the sponsor or designee electronically (for example, laboratory data). The 
investigator is responsible for verifying that data entries are accurate and correct by physically or 
electronically signing the CRF.
The investigator must maintain accurate documentation (source data) that supports the 
information entered in the CRF. Source data may include laboratory tests, medical records, and 
clinical notes.
The investigator must permit study-related monitoring, audits, IRB/IEC review, and regulatory 
agency inspections and provide direct access to source data documents.
Data monitoring and management
The Monitoring Plan includes


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
monitoring details describing strategy, for example, risk-based initiatives in operations 
and quality such as risk management and mitigation strategies and analytical risk-based 
monitoring

methods

responsibilities

requirements

handling of noncompliance issues, and

monitoring techniques.
The sponsor or designee is responsible for the data management of this study including quality 
checking of the data. The sponsor assumes accountability for actions delegated to other 
individuals (for example, contract research organizations).
Study monitors will perform ongoing source data verification to confirm that data entered in the 
CRF by authorized site personnel are accurate, complete, and verifiable from source documents. 
They will also ensure that the safety and rights of participants are being protected, and that the 
study is being conducted in accordance with the currently approved protocol and any other study 
agreements, ICH GCP, and all applicable regulatory requirements.
Records retention and audits
Records and documents, including signed ICFs, pertaining to the conduct of this study must be 
retained by the investigator for the time period outlined in the clinical trial agreement unless 
local regulations or institutional policies require a longer retention period.
No records may be destroyed during the retention period without the written approval of the 
sponsor. No records may be transferred to another location or party without written notification 
to the sponsor.
The sponsor or its representatives will periodically check a sample of the participant data 
recorded against source documents at the study site. The study may be audited by the sponsor or 
its representatives, and by regulatory agencies at any time. Investigators will be given notice 
before an audit occurs.
Data Capture System
The investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness 
of the data reported to the sponsor.
An EDC system will be used in this study for the collection of CRF data. The investigator 
maintains a separate source for the data entered by the investigator or designee into the 
sponsor-provided EDC system. The investigator is responsible for the identification of any data 
to be considered source and for the confirmation that data reported are accurate and complete by 
signing the CRF.
Data collected via the sponsor-provided data capture systems will be stored at third parties. The 
investigator will have continuous access to the data during the study and until decommissioning 
of the data capture systems. Prior to decommissioning, the investigator will receive an archival 
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Data m a na ge d b y a ce ntral ve n d or, s uc h as la b orat or y test data, will be st ore d electr o nicall y i n 
t he ce ntral ve n d or’s data base s yste m a n d re p orts will be pr o vi de d t o t he i n vesti gat or f or re vie w 
a n d rete nti o n. Data will s u bse q ue nt l y be tra nsferre d fr o m t he ce ntral ve n d or t o t he s p o ns or data 
ware h o use.
Data fr o m c o m p lai nt f or ms s u b mitte d t o t he s p o ns or will be e nc o de d a n d st ore d i n t he gl o bal 
pr o d uct c o m plai nt ma na ge me nt s y st e m.
1 0. 1. 6.
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 vest i gat or’s site.
Data re p orte d o n t he C R F t hat are tra nscri be d 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. Curre nt m e dical 
rec or ds must be a vaila ble.
T he defi nit i on of w hat c o nstit utes s o urce data ca n be f o u n d i n Sect i on 1 0. 1. 5 .
1 0. 1. 7.
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 o n w hic h t he cli nical st u d y will be o pe n f or recr uitme nt  of 
parti ci pa nts.
Site Cl os ure
T he s p o ns or desi g nee reser ves t he ri g ht t o cl ose t he st u d y sit e 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 discret i on of t he s p o ns or. St u d y  sit es will be cl ose d u p o n st u d y  
c o mplet i on. A st u d y  site is c o nsi dere d close 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 o llecte d a n d a st u d y-site clos ure visi t has bee n perf or me d.
T he i n vest i gat or ma y i nitiate st u d y-sit e clos ure at a n y  time, pr o vi de d t here i s reas o na ble ca use 
a n d e n o u g h n otice is gi ve n i n a d va nce of t he i nte n de d ter mi nat i on.
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 ons or or i n vesti gat or ma y i ncl u de b ut are 
n ot li mite d t o

fail ure of t he i n vest i gat or t o c o m pl y with t he pr ot oc ol, t he re q uire me nts of t he I R B/I E C 
or l o c al  healt h a ut h orities, t he s p o ns or ’s pr oce d ures, or G C P g ui deli nes

ina de q uate recr ui t me nt of partici pa nts b y t he i n vesti gat or , or

d isc o nti n uat i on of f urt her st u d y  int er ve nt i on de vel o p m e 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 s hall pr o m ptl y i nf or m t he 
in vesti gat ors, t he I E Cs/I R Bs, t he re g ulat or y  a ut h orities, a n d a n y c o ntract researc h or ga nizat i on(s) 
use d i n t he st u d y  of t he reas o n f or ter mi nati on or s us pe nsi o n, as s pecifie d b y t he a p plica ble 
re g ulat or y r e q uire me nts. T he in vesti gat or s hall pr o m pt l y i nf or m t he parti ci pa nts a n d ass ure 
a p pr o priate partici pa nt t hera p y a n d/ or f ollo w - u p.


CONFIDENTIAL
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48
10.1.8.
Publication Policy
In accordance with the sponsor’s publication policy, the results of this study will be submitted 
for publication by a peer-reviewed journal if the results are deemed to be of significant medical 
importance.
10.1.9.
Investigator Information
Physicians with a specialty in infectious disease, critical care, or pulmonary disease may
participate as investigators.
10.1.10.
Long-Term Sample Retention
Sample retention enables use of new technologies, response to regulatory questions, and 
investigation of variable response that may not be observed until later in the development of the 
intervention or after the intervention becomes commercially available.
This table describes the retention period for potential sample types.
Sample Type
Custodian
Retention Period After Last Participant Visit
Pharmacogenetics sample
Sponsor or designee
up to 15 years
Exploratory Biomarker Samples
Sponsor or designee
up to 15 years
PK sample
Sponsor or designee
up to 2 years
Immunogenicity (ADA) sample
Sponsor or designee
up to 15 years


C O N FI D E N TI A L
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4 9
1 0. 2.  
A p pe n di x 2: Cli nic al L a b or at or y Tests

Cli nical la b orat or y  tests will b e p erfor m e d acc or di n g t o t he S o A. A d dit i onal details are 
pr o vi de d i n t he f o ll owi n g ta bl e for s pecific la b orat or y  tests.

A d dit i onal tests ma y be perf or me d at a n y  time d uri n g t he st u d y as deter mi ne d necessar y 
b y t he i n vesti gat or or re q uire d b y  lo c al  re g ulati ons.

Pre g na nc y testi n g will be perf or me d acc or di n g t o t he S o A.

T he f oll owi n g ta bl e descri bes w he n t he l ocal or ce ntral la b orat or y  will be use d.

If t he l ocal la b orat or y res ults are use d t o ma ke eit her a st u d y int er ve ntio n decisi o n  or 
res p o nse e val uati on, t he res ults m ust be rec or de d i n t he C R F.

La b orat or y  res ults t hat c o uld u n bli n d t he st u d y  will not be re p orte d t o st u d y  sites or ot her 
bli n de d pers o n nel.

Pr ot oc ol -s pecific re q uireme nts f or i ncl usi o n or e xcl usi o n of partici pa nts are detaile d i n 
Secti o n 5 of  t he pr ot oc ol.

I n vesti gat ors m ust d oc u me nt t heir re vie w of eac h la b orator y  safet y re p ort.
Cli nic al L a b or at or y Tests
C o m me nts
He m at ol o g y
Assa y e d b y l ocal la b orat or y
He m o gl o bi n
He mat ocrit
Er y t hr oc yte c o u nt ( R B Cs - re d bl o o d cells)
Mea n cell v ol u me 
Mea n cell he m o gl o bi n
Le u k oc ytes ( W B Cs - w h ite bl o o d cells) 
Differe ntial
Ne utr o p hils, se g me nte d
L y m p h oc ytes
M o n oc ytes
E osi n o p hils
Bas o p hils
Platelets
Cell m or p h ol o g y ( R B C a n d W B C)
Cli nic al C he mistr y
Assa y e d b y l ocal la b orat or y
S o di u m
P otassi u m
C hl ori de
Bicar b o nate
T otal bilir u bi n
Direct bilir u bi n
Rec or d o n D a y -1 a n d re peat if si g nifica ntl y a b n or mal val ue
Al kali ne p h os p hatase ( A L P)
Ala ni ne a mi n otra nsferase ( A L T)
As partate a mi n otra nsferase ( A S T)
Bl o o d urea nitr o ge n ( B U N)
Creati ni ne 


CONFIDENTIAL
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50
Clinical Laboratory Tests
Comments
Uric acid
Record on Day -1 and repeat if significantly abnormal value
Total protein
Albumin
Calcium
Phosphorus
Random glucose
Calculations
Completed locally
Hepatitis B surface antigen
Hepatitis B surface antibody
Hepatitis B core antibody (HBcAb) 
Hepatitis C antibody
HIV
SARS-Cov-2 viral infection determination
Local laboratory
SARS-Cov-2 point-of-care
SARS-Cov-2 nasal or nasopharyngeal sample for 
research purposes
Day 1 sample assayed by Lilly-designated laboratory. Subsequent 
samples sent to Lilly-designated laboratory for analysis only if the 
SARS-Cov-2 point-of-care test performed in parallel is positive 
SARS-Cov-2 serology
Assayed by Lilly-designated laboratory.
Urinalysis
Assayed by local laboratory
Specific gravity
pH
Protein
Glucose
Ketones
Bilirubin
Urobilinogen
Blood
Nitrite
Microscopy
If dipstick test is abnormal.
Hormones (female)
Assayed by local laboratory.
Serum pregnancy 
Urine pregnancy
Ethanol/drug screening
Assayed by local laboratory.
Urine or breath ethanol screen
Urine drug screen
Pharmacokinetic (PK) Samples
Assayed by Lilly-designated laboratory.
Results will not be provided to the study sites.
Pharmacogenetic sample
Assayed by Lilly-designated laboratory.
Results will not be provided to the study sites.
Exploratory Biomarker Serum Sample
Assayed by Lilly-designated laboratory.
Results will not be provided to the study sites.
Abbreviations: HIV = human immunodeficiency virus; SARS-Cov-2 = severe acute respiratory syndrome 
coronavirus 2.


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10.2.1.
Blood Sampling Summary
This table summarizes the approximate number of venipunctures and blood volumes for all 
blood sampling (screening, safety laboratories, and bioanalytical assays) during the study.
Purpose
Blood Volume per 
Sample (mL)
Number of Blood 
Samples
Total Volume 
(mL)
Screening testsa
45
1
45
Clinical laboratory testsa
15
7
105
SARS-CoV-2 serology
10
5
50
Pharmacokinetics 
4
11
44
Immunogenicity
10
4
40
Blood discard for cannula patency
1
5
5
Pharmacogenetics
10
1
10
Serum for exploratory biomarkers
10
5
50
Total
349
Total for clinical purposes (rounded up to nearest 10 mL)
350
a
Additional samples may be drawn if needed for safety purposes.


C O N FI D E N TI A L
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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 i s a n y u nt o war d me dical occ urre nce i n a cli nical st u d y partici pa nt te mp orall y 
ass ociate d wi t h t he use of st u d y int er ve nt i on, w het her or n ot c o nsi dere d relate d t o t he st u d y  
i nter ve nt i on.
N O T E: 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 orally ass oci ate d wit h t he 
use of st u d y  int er ve nt i on.
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 olo g y , cli nical c he mistr y, or urinal ysis) or 
ot her safet y assess me nts ( f or e xa m ple, E C G, ra diol o gical sca ns, vi t al si g ns 
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 
sig nifica nt i n t he me dical a n d scie ntific j u d g me nt of t he i n vest i gat or (i.e., n ot relate d t o 
pr o gressi o n of u n derl yi n g disease).

E xacer bat i on of a c hr o nic or i nter mitte nt pre -exist i n g c o n diti on i ncl u di n g eit her a n 
i ncrease i n fre q ue nc y a n d/ or i nte nsity of  t he c o n ditio n .

Ne w c o n dit i ons detecte d or dia g n ose d after st u d y  i nter ve nti on a d mi nistrati o n e ve n 
t ho u g h it m a 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 nt i on or a c o nc o mita nt me dicat i on. O ver d ose per se will n ot be re p orte d as a n 
A E/ S A E u nless it is a n i n t e ntio n al  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 ose s h o ul d be re p orte d re gar dless of se q uelae.
E ve nts N O T Meeti n g t he A E Defi niti o n

Lac k of dr u g effect is n ot a n A E i n cli nical st u dies, beca use t he p ur p ose of t he cli nical 
st u d y is t o esta blis h treat me nt effect.

T he f o ll owi n g s t u d y-s pecific cli nical e ve nts r elate d t o C O VI D -1 9 are e xe m pt fr o m A E
re p orti n g u nless t he i n vesti gat or dee ms t he e ve nt t o be relate d t o t he a d mi nistrati o n of 
i nter ve nt i on:
o
H y p o xe mia d ue t o C O VI D -1 9 re q uir i n g s u p ple me ntal o x yg e n;
o
H y p o xe mia d ue t o C O VI D -1 9 re q uiri n g n o n -i n vasi ve ve ntilati o n or hi g h fl o w 
o x y ge n de vices;


C O N FI D E N TI A L
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o
Res pirat or y  fail ure d ue t o C O VI D -1 9 re q uiri n g i n vasi ve mec ha nical ve nt ilati on 
or E C M O

A n y cli nicall y  sig nifica nt a b n or mal la b orat or y  fi n din gs or ot her a b n or mal safet y 
assess me nts w hic h are ass ociate d wit h t he u n derl yi n g disease u n der st u d y , 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 ditio n.

T he disease/ dis or der bei n g st u die d or e x pecte d pr o gres sio n , sig ns, or s y m pt o m s of t he 
di sease/ 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 ditio n.

Me dical or s ur gical pr oce d ure , s uc h as e n d osc o p y or a p pe n dect o m y. The c o n dit i on t hat 
lea ds t o t he pr oce d ure is t he A E.

Si t u atio 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 nt ici pate d da y-t o-da y fl uct uati o ns of pre-e xist i n g disease(s) or c o n diti on(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 S A E
Pl ease n ote: If a n e ve nt is n ot a n A E per defi niti on a b o ve, t he n it ca n n ot be a n S A E.
A n S A E is defi ne d as a n y A E t h at:
a.
Res ults i n de at h
b.
Is i m me di atel y life-t hre ate ni n g
T he ter m  'life-t hreate ni n g' i n t he defi niti on of 'seri o us' refers t o a n e ve nt i n w hic h t he 
parti ci 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, w hic h 
h y p ot heti call 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 a liz ati o n

I n ge neral, h os pitalizati on si g nifies t hat t he partici pa nt has bee n a d mitte d t o h os pi t al
f or >” 2 3 h o ur o bser vat i on” a n d/ or treat me nt t hat w o uld 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 ur i n g 
h os pi talizatio n are A Es. If a c o m plicat i on pr ol o n gs h os pi talizati on or f ulfills a n y ot her 
serio us cri teria, 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 on” 
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 pitalizat i on f or elect i ve treat me nt of a pre-e xisti n g c o n dit i on t hat di d n ot w orse n 
fr om baseli ne is n ot c o nsi dere d a n A E.
d.
Res ults i n persiste nt dis a bilit y/i nc a p acit y

T he ter m disa bili t y mea ns a s u bsta nt ial disr u pt i on of a pers o n’s a bilit y t o c o n d uct 
n or m al lif e fu nct i ons.

T his defi nit i on 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 
sig nifica nce s uc h as u nc o m p licate d hea dac he, na usea, v o miti n g, diarr hea, i nfl ue nza, 


C O N FI D E N TI A L
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5 4
a n d acci de ntal tra u ma ( f or e xa m ple, s prai ne d a n kle) w hic h ma y int erfere wit h or
pre ve nt e ver y d a y  lif e fu nct i ons b ut d o n ot c o nstit ute a s u bsta nt ial disr u pti o n.
e.
Is a c o n ge nit al a n o m al y/ birt h defect
f.
Ot her sit u ati o ns:

Me dical or scie nt ific j u d g me nt s h o ul d be e xercise d 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 u atio ns s uc h as i m p orta nt me dical e ve nts t hat ma y n ot be 
i m me diatel y life-t hreate ni n g or res ult i n deat h or h os pitalizati o n b ut ma y je o par dize t he 
parti ci pa nt or ma y re q uir e me dical or s ur gical i nter ve nt i on t o pre ve nt o ne of t he ot her 
o utc o m es liste d i n t he a b o ve defi nit i on. T hese e ve nts s h o ul d us uall y be c o nsi dere d 
serio us.
o
E xa m ples of s uc h e ve nts i ncl u de 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 for 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 pitalizatio 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 .
1 0. 3. 3.
Rec or di n g a n d F oll o w - Up of A E a n d/ or S A E
A E a n d S A E Rec or di n g
W he n a n A E/ 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 m e nt atio n ( f or e xa m ple, h os pit al pr o gress n otes, lab orat or y  re p orts, a n d dia g n ostics 
re p orts) relate d t o t he e ve nt.
T he i n vest i gat or will t he n rec or d all rele va nt A E/ S A E i nf or mati on i n t he C R F.
It is n ot acce pta ble f or t he i n vest i 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 S p o ns or o r desi g nee i n lie u of c om p leti on of t he A E/ S A E C R F pa ge.
T here m a 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 
S p o ns or or desi g nee . I n t his case, all partici pa nt i de ntifiers, e xce pt 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 S p o ns or or desi g nee .
T he i n vest i 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 mat i on. W he ne v er p ossi ble, t he dia g n osis ( n ot t he i n di vi d ual 
sig ns/s y m pt o m s) will be d oc u me nte d as t he A E/ S A E.
Assess me nt of I nte nsit y / Se verit y
T he i n vest i gat or will ma ke a n assess me nt of i nte nsity 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 o ne of t he f o ll owi n g cate g ori es, w hic h t o get her wit h seri o us criteria 
o n t he A E C R F (“res ult s i n deat h” a n d “life-t hreate ni n g”), are ali g ne d wit h t he D i visi on of 
AI D S Ta ble f or Gra di n g t he Se verit y of  A d ult a n d Pe diatric A d verse E ve nts, versi o n 2. 1 
(D AI D S 2 0 1 7).
Mil d:
Mil d s y m pt o ms ca usi n g n o or mi ni mal i nterfere nce wit h us ual s ocial a n d f u ncti o nal 
acti vit ies, wit h i nter ve nti o n n ot i n dicate d.


C O N FI D E N TI A L
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M o der ate:
M o derate s y m pt o ms ca usi n g greater t ha n mi ni mal i nterfere nce wit h us ual 
s o cial a n d fu n cti o n al  acti vities, wit h i nter ve ntio n i n dicate d .
Se vere: Se vere s y m pt o ms ca usi n g i na bilit y t o perf or m us ual s ocial a n d f u ncti o nal 
acti vit ies, wit h i nter ve nti o n or h os pitalizati o n i n dicate d.
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 nit i on o f 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 vest i 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 on a n d eac h 
occ urre nce of eac h A E/ S A E.
A “reas o na ble p ossi bilit y” o f a r elat i ons 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 relat i ons hi p ca n n ot be r ul e d o ut .
T he i n vest i gat or will use cli nical j u d g me nt t o deter mi ne t he relati ons hi p.
Alt er nat i ve ca uses, s uc h as un 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 int er ve ntio n a d mi nistrati o n will be 
c o nsi dere d a n d i n vest i gate d.
T he i n vest i gat or will als o c o ns ult t he I B a n d/ or Pr o d uct I nf or mati o n, f or mar kete d pr o d ucts, i n 
his/ her assess me nt.
F or eac h A E/ S A E, t he i n vest i gat or m ust
d oc u me nt i n t he me dical n otes t hat he/s he has 
re vie we d t he A E/ S A E a n d has pr o vi de d a n assess me nt of ca usality.
T here m a y be sit u atio ns i n w hic h a n S A E has occ urre d, a n d t he i n vest i gat or has mi ni mal 
i nf or mat i on t o i ncl u de i n t he i nit ial re p ort t o S p o ns or or desi g nee . H o we ver, it is ver y 
i m p orta nt t hat t he i n vesti gat or al wa ys assess t he ca usalit y f or e ver y e ve nt bef ore t he i nitial 
tra ns missi on of t he S A E data t o S p o ns or or desi g nee .
T he i n vest i gat or ma y c ha n ge t heir o pi ni o n of ca usalit y after c o nsiderat i on of  fol l ow- u p 
i nf or mat i on a n d se n d a S A E f oll o w -u p re p ort wi t 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 crit eria 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.
F oll o w -u p of A Es a n d S A Es
T he i n vest i 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 uat i ons as me dicall y i n dicate d or as re q ueste d b y S p o ns or or 
desi g nee t o eluci 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 dit i onal la b orat or y  tests or i n vesti gati o ns, hist o pat h ol o gical e xa mi nati ons, or 
c o ns ultati o n wit h ot her healt h care pr ofessi o nals.


C O N FI D E N TI A L
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If a partici pa nt di es 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 niz e d fol l ow- u p peri o d, 
t he i n vest i gat or will pr o vi de t he s p o ns or or desi g nee wit h a c o p y of a n y p ost-m o rt e 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 mat i on will be rec or de d i n t he ori gi nall y c o m plete d C R F.
T he i n vest i gat or will s u b mit a n y u p date d S A E data t o S p o ns or or desi g nee wi t hi n 2 4 h o urs of 
receipt of  t he i nf or mat i on.
1 0. 3. 4.
Re p orti n g of S A Es
S A E Re p orti n g vi a P a per C R F
Facsi mile tra ns missi o n of t he S A E pa per C R F is t he preferre d met h o d t o tra ns mit t his 
i nf or mat i on t o t he s p o ns or.
I nitial notificati o n via tele p h o ne d oes n ot re place t he nee d f or t he i n vest i gat or t o c o m plete a n d 
sig n t he S A E C R F pa ges wit hi n t he desi g nate d re p orti n g t i me fra mes.
C o ntacts f or S A E re p orti n g ca n be f o u n d i n site trai ni n g d oc u me nts .


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10.4.
Appendix 4: Contraceptive Guidance and Collection of Pregnancy 
Information
10.4.1.
Women
Only women of non-childbearing potential may participate in this study.
Definitions:
Woman of Childbearing Potential
A woman is considered fertile following menarche and until becoming postmenopausal unless 
permanently sterile (see below).
If fertility is unclear (for example, amenorrhea in adolescents or athletes) and a menstrual cycle 
cannot be confirmed before first dose of study intervention, additional evaluation should be 
considered.
Woman Not of Childbearing Potential
Women in the following categories are not considered woman of childbearing potential
1. Premenarchal
2. Premenopausal female with 1 of the following:

Documented hysterectomy

Documented bilateral salpingectomy

Documented bilateral oophorectomy
For individuals with permanent infertility due to an alternate medical cause other than the above, 
(for example, mullerian agenesis, androgen insensitivity), investigator discretion should be 
applied to determining study entry.
Note: Documentation can come from the site personnel’s: review of the participant’s medical 
records, medical examination, or medical history interview.
3. Postmenopausal female is defined as, women with

12 months of amenorrhea for women >55 years, with no need for follicle-stimulating 
hormone

12 months of amenorrhea for women >40 years with FSH ≥40 mIU/mL and no other 
medical condition such as anorexia nervosa and not taking medications during the 
amenorrhea (for example, oral contraceptives, hormones, gonadotropin-releasing 
hormone, anti-estrogens, selective estrogen receptor modulators, or chemotherapy 
that induced amenorrhea)
10.4.2.
Men
Men, regardless of their fertility status, must agree to either remain abstinent (if this is their 
preferred and usual lifestyle) or use condoms as well as 1 additional highly effective method of 
contraception (less than 1% failure rate) or effective method of contraception with nonpregnant 
women of childbearing potential partners for the duration of the study and until their plasma 
concentrations are below the level that could result in a relevant potential exposure to a possible 
fetus, predicted to be 140 days after the last dose.


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Men with pregnant partners should use condoms during intercourse for the duration of the study 
and until the end of estimated relevant potential exposure to the fetus, predicted to be 140 days 
after the last dose.
Acceptable Methods of Contraception for Female Partners of Male Participants
Highly effective methods of contraception (less than 1% failure rate) comprise, but are not 
limited to

combination oral contraceptives

implanted contraceptives, or

intrauterine devices.
Effective methods of contraception comprise but are not limited to diaphragms with spermicide 
or cervical sponges.
Men and their partners may choose to use a double–barrier method of contraception that must 
include use of a spermicide.
10.4.3.
Collection of Pregnancy Information
Male participants with partners who become pregnant
The investigator will attempt to collect pregnancy information on any male participant’s female 
partner who becomes pregnant while the male participant is in this study. This applies only to 
male participants who receive study intervention.
After obtaining the necessary signed informed consent from the pregnant female partner directly, 
the investigator will record pregnancy information on the appropriate form and submit it to the 
sponsor within 24 hours of learning of the partner’s pregnancy.
The female partner will also be followed up to determine the outcome of the pregnancy.
Information on the status of the mother and child will be forwarded to the sponsor. Generally, the 
follow-up will be no longer than 6 to 8 weeks following the estimated delivery date. Any 
termination of the pregnancy will be reported including fetal status (presence or absence of 
anomalies) and indication for the procedure.
Female participants who become pregnant
The investigator will collect pregnancy information on any female participant who becomes 
pregnant while participating in this study. The initial information will be recorded on the 
appropriate form and submitted to the sponsor within 24 hours of learning of a participant’s 
pregnancy.
The participant will be followed up to determine the outcome of the pregnancy. The investigator 
will collect follow-up information on the participant and the neonate, and the information will be 
forwarded to the sponsor. Generally, follow-up will not be required for longer than 6 to 8 weeks 
beyond the estimated delivery date. Any termination of pregnancy will be reported, including 
fetal status (presence or absence of anomalies) or indication for the procedure.
While pregnancy itself is not considered to be an AE or SAE, any pregnancy complication or 
elective termination of a pregnancy for medical reasons will be reported as an AE or SAE.


C O N FI D E N TI A L
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5 9
A s p o nta ne o us a b orti o n ( occ urri n g at < 2 0 wee ks gestati o nal a ge) or still birt h ( occ urri n g at > 2 0
wee ks gestati o nal a ge) is al wa ys c o nsi dere d t o be a n S A E a n d will be re p orte d as s uc h.
A n y p ostst u d y pre g na nc y -relate d S A E c o nsi dere d reas o na bl y relate d t o t he st u d y int er ve nt i on b y 
t he i n vest i gat or will be re p orte d t o t he s p o ns or as descri be d i n Secti o n 8. 3. 4 . W hile t he 
i n vesti gat or is n ot o bli gate d t o acti vel y see k t his i nf or mati on i n f or mer st u d y partici pa nts, he or 
s he ma y lear n of a n S A E t hr o u g h s p o nta ne o us re p orti n g .


C O N FI D E N TI A L
J 2Z- M C -P G A B
6 0
1 0. 5.
A p pe n di x 5 : Ge netics
Sa m p le c ollecti on i nf or mati on is f ou n d i n A p pe n di x 2, Secti o n 1 0. 2 .
Ge net ic variat i on ma y i m pact a partici pa nt’s res p o nse t o st u d y int er ve nt i on, s usce pt i bility t o, a n d 
se verity a n d pr o gressio n of  disease. Varia ble res p o nse t o st u d y int er ve nt i on ma y be d ue t o 
ge net ic deter mi na nts t hat i m pact dr u g a bs or pti o n, distri b uti on, meta b o lism,  a n d e xcretio n; 
mec ha nis m o f actio n of  t he dr u g; disease eti ol og y; a n d/ or m ol ec ular s u bt y pe of t he disease bei n g 
treate d. T heref ore, w here l ocal re g ulati ons a n d I R B/I E C all o w, a bl o o d sa mple will be c ollecte d 
f or D N A a nal ysis fr om c o nse nti n g part ici pa nts.
D N A sa m ples ma y be use d f or researc h relate d t o S A R S -C o V - 2 a n d relate d diseases. T he y ma y 
als o be use d t o de vel o p tests/assa ys i ncl u di n g dia g n ostic tests relate d t o L Y 3 8 3 2 4 7 9 or 
S A R S -C o V - 2. Ge netic researc h ma y c o nsist of t he a nal ysis o f 1 or m ore ca n di d ate ge nes or t he 
a nal ysis of ge net ic mar kers t hr o u g h o ut t he ge n o me  as a p pr o priate.
T he sa m ples ma y be a nal yze d as part of a m ultist u d y assess me nt of ge netic fact ors i n v ol ve d i n 
t he res p o nse t o L Y 3 8 3 2 4 7 9 or s t u d y int er ve nt i ons of  t his class t o u n dersta n d stu d y disease or 
r elate d c o n ditio ns.
T he res ults of ge net ic a nal yses ma y be re p orte d i n t he cli nical st u d y re p ort or i n a se parate st u d y 
s u m mar y.
T he s p o ns or 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 nt ialit y.
T he sa m ples will be retai ne d at a facilit y selecte d b y t he s p o ns or or its desi g nee w hile researc h 
o n S A R S -C o V - 2 c o nt i n ues, b ut n o l o n ger t ha n 1 5 years or ot her peri o d as per l ocal 
re q uire me nts.


C O N FI D E N TI A L
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6 1
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
He p atic E v al u ati o n Testi n g
See Secti o n 8. 2. 5 f or g ui da nce o n a p pr o priate test selecti on.
Testi n g will be perf or me d l ocall y .
He m at ol o g y
Cli nic al C he mistr y
H e m o gl o bi n
T otal  bilir u bi n
H e m at o crit
Di rect bilir u bi n
Er y t hr o c ytes ( R B Cs - re d blo o d cells)
Al kali ne p h os p hatase ( A L P)
Le u k oc y tes ( W B Cs - w hite bl o o d cells)
Ala ni ne a mi n otra nsferase ( A L T)
Differe nt ial:
As partate a mi n otra nsferase ( A S T)
  Ne utr o p hils, se g me nte d
Ga m ma -gl uta m yl  tra nsferase ( G G T)
  L y m p h oc ytes
Creati ne ki nase ( C K)
  M o n oc y t es
Ot her C he mistr y
  Bas o p hils
Aceta mi n o p he n
  E osi n o p hils
Aceta mi n o p he n pr otei n a d d ucts
Pl at elets
Al kali ne p h os p hatase is oe nz y mes
Cell m or p h o l og y  ( R B C a n d W B C)
Cer ul o pl as mi n
C o a g ul ati o n
C o p per
Et h yl alc o h o l ( Et O H)
Pr ot hr o m bi n t i me, I N R ( P T-I N R)
Ha pt o gl o bi n
Ser ol o g y
I mm u n o gl o b uli n I g A ( q ua ntitati ve)
He pati tis A vir us ( H A V) testin g:
I mm u n o gl o b uli n I g G ( q ua ntitati ve)
  H A V t otal a nt i b o d y
I mm u n o gl o b uli n I g M ( q ua nt itati ve)
  H A V I g M a nti b o d y
P h os p hat i dylet ha n o l ( P Et h)
He patis B vir us ( H B V) testi n g:
Uri ne C he mistr y
  He patit is B s urface a nti ge n ( H Bs A g)
Dr u g scree n
  He patit is B s urface a nti b o d y (a nti-H Bs)
Et h yl gl uc ur o ni de ( Et G)
  He patit is B c ore t otal a nti b o d y (a nti-H Bc)
Ot her Ser ol o g y
  He patit is B c ore I g M a nti b o d y
A nt i-n uclear a nt i b o d y ( A N A)
  He patit is B c ore I g G a nti b o d y
A nt i-s mo ot h  muscle a nti b o d y  ( AS M A) a
  H B V D N A c
A nt i-act i n a nti b o d yb
He patis C vir us ( H C V) testi n g:
E pstei n -Barr vir us ( E B V) testi n g:
  H C V a nti b o d y
  E B V a nti b o d y


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  HCV RNAc
  EBV DNAc
Hepatitis D virus (HDV) testing:
Cytomegalovirus (CMV) testing:
  HDV antibody
  CMV antibody
Hepatitis E virus (HEV) testing:
  CMV DNAc
  HEV IgG antibody
Herpes simplex virus (HSV) testing:
  HEV IgM antibody
  HSV (Type 1 and 2) antibody
  HEV RNA c
  HSV (Type 1 and 2) DNAc
Microbiology
Liver kidney microsomal type 1 (LKM-1) antibody
Culture:
  Blood
  Urine
a
Not required if anti-actin antibody is tested.
b
Not required if anti-smooth muscle antibody (ASMA) is tested.
c
Reflex/confirmation dependent on regulatory requirements, testing availability, or both.


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10.7.
Appendix 7: Recommended Laboratory Testing for Hypersensitivity 
Events
Laboratory assessments should be performed if the participant experiences generalized urticaria 
or if anaphylaxis is suspected.

Collect sample after the participant has been stabilized, and within 1 to 2 hours of the 
event; however, samples may be obtained as late as 12 hours after the event as analytes 
can remain altered for an extended period of time. Record the time at which the sample 
was collected.

Obtain a follow-up sample after approximately 4 weeks.


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Clinical Lab Tests for Hypersensitivity Events
Hypersensitivity Tests
Notes
Selected test may be obtained in the event of anaphylaxis or 
systemic allergic/hypersensitivity reactions.
LY3832479 anti-drug 
antibodies 
(immunogenicity/ADA)
Assayed by Lilly-designated laboratory.
Results will not be provided to the investigative sites.
LY3832479 concentrations 
(PK)
Assayed by Lilly-designated laboratory.
Results will not be provided to the investigative sites.
Tryptase
Assayed by Lilly-designated laboratory.
Results will not be provided to the investigative sites.
Urine N-methylhistamine testing is performed in addition to 
tryptase testing. Collect the first void urine following the event. 
Collect a follow-up urine sample after approximately 4 weeks.
Note: If a tryptase sample is obtained more than 2 hours after the 
event (that is, within 2 to 12 hours), or is not obtained because more 
than 12 hours have lapsed since the event, collect a urine sample for 
N-methylhistamine testing. 
N-methylhistamine
Assayed by Lilly-designated laboratory.
Results will not be provided to the investigative sites.
Drug-specific IgE
Will be performed if a validated assay is available.
Assayed by Lilly-designated laboratory.
Results will not be provided to the investigative sites.
Basophil activation test
Will be performed if a validated assay is available.
Assayed by Lilly-designated laboratory.
Results will not be provided to the investigative sites.
NOTE: The basophil activation test is an in vitro cell based assay 
that only requires a serum sample. It is a surrogate assay for drug-
specific IgE, but is not specific for IgE.
Complement (C3, C3a, and 
C5a)
Assayed by Lilly-designated laboratory.
Results will not be provided to the investigative sites.
Cytokine panel
Assayed by Lilly-designated laboratory.
Results will not be provided to the investigative sites.
Abbreviations: IgE = immunoglobulin E; PK = pharmacokinetic.


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10.8.
Appendix 8: Abbreviations
Term
Definition
ACE2
angiotensin-converting enzyme 2
ADE
antibody-dependent enhancement
AE
adverse event
ALP
alkaline phosphatase
ALT
alanine aminotransferase
AST
aspartate aminotransferase
AUC
area under the curve
AUC(0-¥) 
AUC(0-∞) area under the concentration versus time curve from zero to infinity
BMI
body mass index
CFR
Code of Federal Regulations
CK
creatine kinase
Cmax
maximum observed drug concentration
CMV
cytomegalovirus
complaint
A complaint is any written, electronic, or oral communication that alleges deficiencies 
related to the identity, quality, purity, durability, reliability, safety or effectiveness, or 
performance of a drug or drug delivery system.
Compliance
Adherence to all study-related, good clinical practice (GCP), and applicable regulatory 
requirements.
COVID-19
coronavirus disease-2019
CP
Clinical pharmacologist
CRF
case report form
CRP
clinical research physician: Individual responsible for the medical conduct of the study. 
Responsibilities of the CRP may be performed by a physician, clinical research 
scientist, global safety physician or other medical officer.
CRU
clinical research unit
D. Bil
direct bilirubin
EBV
Epstein-Barr virus
ECG
electrocardiogram
ECMO
extracorporeal membrane oxygenation
eCRF
electronic case report form
EDC
electronic data capture
enroll
The act of assigning a participant to a treatment. Participants who are enrolled in the 
study are those who have been assigned to a treatment.
Enter
Participants entered into a study are those who sign the informed consent form directly 
or through their legally acceptable representatives.


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Term
Definition
FIH
first in human
FSH
follicle-stimulating hormone
GCP
good clinical practice
GGT
gamma-glutamyl transferase
HCV
hepatitis C virus
HDV
hepatitis D virus
HIV
human immunodeficiency virus
IB
Investigator’s Brochure
ICF
informed consent form
ICH
International Council for Harmonisation
IEC
independent ethics committee
IgG
immunoglobulin G
Informed consent
A process by which a participant voluntarily confirms his or her willingness to 
participate in a particular study, after having been informed of all aspects of the study 
that are relevant to the participant’s decision to participate. Informed consent is 
documented by means of a written, signed and dated informed consent form.
Investigational 
product
A pharmaceutical form of an active ingredient or placebo being tested or used as a 
reference in a clinical trial, including products already on the market when used or 
assembled (formulated or packaged) in a way different from the authorized form, or 
marketed products used for an unauthorized indication, or marketed products used to 
gain further information about the authorized form.
IRB
institutional review board
ISR
injection site reaction
IV
intravenous(ly)
mAb
monoclonal antibody
NOAEL
no-observed-adverse-effect-level
participant
Equivalent to CDISC term “subject”: an individual who participates in a clinical trial, 
either as recipient of an investigational medicinal product or as a control
PGAA
J2Z-MC-PGAA
PGAB
J2Z-MC-PGAB
PK
pharmacokinetics
PT-INR
prothrombin time and international normalized ratio
RBD
receptor-binding domain
SAE
serious adverse event
SAP
statistical analysis plan
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2
SC
subcutaneous(ly)
screen
The act of determining if an individual meets minimum requirements to become part of 
a pool of potential candidates for participation in a clinical study. 


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Term
Definition
SoA
Schedule of Activities
TBL
total bilirubin
TCR
tissue cross-reactivity
TEAE
treatment-emergent adverse event: An untoward medical occurrence that emerges 
during a defined treatment period, having been absent pretreatment, or worsens relative 
to the pretreatment state, and does not necessarily have to have a causal relationship 
with this treatment.
tmax
time of maximum observed drug concentration
ULN
upper limit of normal
VAS
visual analog scale


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11.
References
[DAIDS] Division of AIDS. National Institute of Allergy and Infectious Diseases. National 
Institutes of Health. US Department of Health and Human Services. Division of AIDS 
(DAIDS) table for grading the severity of adult and pediatric adverse events. Corrected version 
2.1. July 2017. Accessed: 14 April 2020. 
https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf
Gilead Sciences, Inc. Fact sheet for health care providers: emergency use authorization (EUA) of 
Veklury® (remdesivir). July 2020. Accessed August 13, 2020. 
https://www.fda.gov/media/137566/download.
Graham BS. Rapid COVID-19 vaccine development. Science. 2020;368(6494):945-946.
https://doi.org/10.1126/science.abb8923.
Lieberman P, Nicklas RA, Randolph C, et al. Anaphylaxis – a practice parameter update 2015. 
Ann Allergy Asthma Immunol. 2015;115(5):341-384.
https://doi.org/10.1016/j.anai.2015.07.019
[FDA] Food and Drug Administration. Recommendations for investigational COVID-19 
convalescent plasma. Published September 02, 2020. Accessed September 22, 2020.
https://www.fda.gov/vaccines-blood-biologics/investigational-new-drug-ind-or-device-
exemption-ide-process-cber/recommendations-investigational-covid-19-convalescent-plasma.
Hamming I, Timens W, Bulthuis MLC, et al. Tissue distribution of ACE2 protein, the functional 
receptor for SARS coronavirus. A first step in understanding SARS pathogenesis. J. Pathol. 
2004;203(2):631-637. https://doi.org/10.1002/path.1570
Human Protein Atlas Project website. Accessed May 14, 2020.
https://www.proteinatlas.org/ENSG00000130234-ACE2/tissue
Simons FER, Ebisawa M, Sanchez-Borges M, et al. 2015 update of the evidence base: World 
Allergy Organization anaphylaxis guidelines. World Allergy Organ J. 2015;8(1):32.
https://doi.org/10.1186/s40413-015-0080-1
Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin 
Nurs. 2005;14(7):798-804. https://doi.org/10.1111/j.1365-2702.2005.01121.x


L e o  D o c u m e n t  I D  =  e 0 8 7 e 1 a 8 - c a 4 f - 4 1 a 2 - 8 6 e c - 5 6 e 8 3 9 e 5 4 c 2 e
A p p r o v e r :  
A p p r o v a l  D a t e  &  T i m e :  3 0 - S e p - 2 0 2 0  1 4 : 1 0 : 1 7  G M T
S i g n a t u r e  m e a n i n g :  A p p r o v e d
A p p r o v e r :  
A p p r o v a l  D a t e  &  T i m e :  3 0 - S e p - 2 0 2 0  1 4 : 1 2 : 4 7  G M T
S i g n a t u r e  m e a n i n g :  A p p r o v e d
P P D
P P D

SAP_001.pdf: 
Statistical A nal ysis Pla n ( v 1):  J 2 Z- M C- P G A B
A Ra n d o mize d, Place b o- C o ntr olle d, Partici pa nt- a n d I n vesti gat or- Bli n d, P hase 1 St u d y t o 
E val uate t he P har mac o ki netics, Safet y, a n d T olera bilit y of L Y 3 8 3 2 4 7 9 A d mi nistere d 
S u bc uta ne o usl y t o Healt h y Partici pa nts
N C T 0 4 6 1 1 7 8 9
A p pr o val Date: 1 6- Oct- 2 0 2 0


Fi nal v 1 , 1 5 Oct 2 0 2 0
             Pa ge 1 of 1 7
S T A TI S TI C A L A N A L Y SI S P L A N
A R a n d o mize d, Pl ace b o -C o ntr olle d , P artici p a nt- a n d I n vesti g at or -Bli n d, P h ase 1 St u d y t o 
E v al u ate t he P h ar m ac o ki netics, S afet y, a n d T oler a bilit y of L Y 3 8 3 2 4 7 9 A d mi nistere d 
S u bc ut a ne o usl y t o He alt h y P artici p a nts
Stati stical A nal ysis Pla n Stat us : Fi nal v 1
Stati stical A nal ysis Pla n Date : 1 3 -Oct o ber -2 0 2 0
St u d y  Dr u g: L Y 3 8 3 2 4 7 9
S p o ns or Refere nce : J 2 Z-M C -P G A B 
C o va nce C R U St u d y : 1 0 0 0 0 7 1 - 8 4 5 4 0 7 0
Cli nical P hase I
A p pr o v al D at e: 1 6- O ct- 2 0 2 0 G M T


Fi nal v 1 , 1 5 Oct 2 0 2 0
             Pa ge 2 of 1 7
Stati stical A nal ysis Pla n 
C O N FI D E N TI A L
C o va nce Cli nical St u d y  N o. 1 0 0 0 0 7 1 - 8 4 5 4 0 7 0
S p o ns or Refere nce J 2 Z-M C -P G A B 
1. T A B L E O F C O N T E N T S
1.
T A B L E O F C O N T E N T S .....................................................................................................2
2.
A B B R E VI A TI O N S ..............................................................................................................4
3.
I N T R O D U C TI O N ...............................................................................................................6
4.
S T U D Y O BJ E C TI V E S ........................................................................................................6
4. 1
Pri mar y O bject i ve..........................................................................................................6
4. 2
Sec o n dar y  O bjecti ve......................................................................................................6
4. 3
E x pl or at or y O bjecti ves..................................................................................................7
5.
S T U D Y D E SI G N .................................................................................................................7
6.
T R E A T M E N T S ...................................................................................................................8
7.
S A M P L E SI Z E J U S TI FI C A TI O N .......................................................................................8
8.
D E FI NI TI O N O F A N A L Y S I S P O P U L A TI O N S..................................................................8
9.
S T A TI S TI C A L M E T H O D O L O G Y .....................................................................................9
9. 1
Ge neral ..........................................................................................................................9
9. 2
D e m o gra p hics a n d P arti ci pa nt Dis p ositio n .....................................................................9
9. 3
P har mac o ki net ic Assess me nt .........................................................................................9
9. 3. 1
P har mac o ki net ic A nal ysis .....................................................................................9
9. 3. 2
P har mac o ki net ic Statistical Met h o d ol o g y ...........................................................1 3
9. 4
S af et y a n d T olera bilit y Assess me nts ............................................................................1 3
9. 4. 1
A d verse e ve nts ...................................................................................................1 3
9. 4. 2
C o nc o mita nt me dicat i on .....................................................................................1 4
9. 4. 3
Cli nical la b orat or y  para meters............................................................................1 4
9. 4. 4
Vi t al si g ns ..........................................................................................................1 4
9. 4. 5
Electr ocar di o gra m ( E C G) ...................................................................................1 4
9. 4. 6
He pati c M o nit orin g ............................................................................................1 4
9. 4. 7
I mm u n o ge nicit y Assess me nts .............................................................................1 5
9. 4. 8
H y perse nsi tivi t y reacti ons ...................................................................................1 5
9. 4. 9
I njecti on- Si te Reactio ns...................................................................................... 1 5
9. 4. 1 0
Se vere ac ute res pirat or y  s y n dr o me c or o na vir us 2 ( S A R S-C O V -2) i nfect i on .......1 6
9. 4. 1 1
Ot her assess me nts ...............................................................................................1 6
9. 4. 1 2
S af et y a n d T olera bilit y Statisti c al Met h o d olo g y.................................................. 1 6


Fi nal v 1 , 1 5 Oct 2 0 2 0
             Pa ge 3 of 1 7
Stati stical A nal ysis Pla n 
C O N FI D E N TI A L
C o va nce Cli nical St u d y  N o. 1 0 0 0 0 7 1 - 8 4 5 4 0 7 0
S p o ns or Refere nce J 2 Z-M C -P G A B 
1 0. I N T E RI M A N A L Y S E S .....................................................................................................1 6
1 1. C H A N G E S F R O M T H E P R O T O C O L S P E CI FI E D S T A T I S TI C A L A N A L Y S E S ............1 6
1 2. R E F E R E N C E S ..................................................................................................................1 6
1 3. D A T A P R E S E N T A TI O N ..................................................................................................1 7
1 3. 1 Deri ve d Para meters .....................................................................................................1 7
1 3. 2 Missi n g Data ...............................................................................................................1 7
1 3. 3 I ns ufficie nt D at a for Prese ntati o n ................................................................................1 7


Fi nal v 1 , 1 5 Oct 2 0 2 0
             Pa ge 4 of 1 7
Stati stical A nal ysis Pla n 
C O N FI D E N TI A L
C o va nce Cli nical St u d y  N o. 1 0 0 0 0 7 1 - 8 4 5 4 0 7 0
S p o ns or Refere nce J 2 Z-M C -P G A B 
2. A B B R E VI A TI O N S
A b bre viat i ons pertai n t o t he Statist ical A nal ysis Pla n ( S A P) o nl y ( n ot t he ta bles, fi g ures a n d 
listi n gs [ T F Ls]).
% A U C(t
last-∞)
Perce nta ge of A U C( 0 -∞) e xtra p olate d
A E
A d verse e ve nt
A D A
A nt i-dr u g a nt i b o d y
A L P
Al kali ne p h os p hatase
A L T
Ala ni ne a mi n otra nsferase
A U C
Area u n der t he c o nce ntrati o n vers us ti me c ur ve
A U C( 0 -∞)
Area u n der t he c o nce ntrati o n vers us ti me c ur ve fr o m time zer o t o 
i nfi nity
A U C( 0 -tlast)
Area u n der t he c o nce ntrati o n vers us ti me c ur ve fr o m t i me zer o t o 
ti me t, w here t is t he last ti me p oi nt wit h a meas ura ble c o nce ntratio n
B Q L
Bel o w t he l o wer li mit of q ua nt itatio n
C last
Last q ua nt ifia ble dr u g c o nce ntrati o n
C ma x
Ma xi m u m o bser ve d dr u g c o nce ntrati o n
CI
C o nfi de nce int er val
C L/ F
A p pare nt t otal b o d y  cleara nce of  dr u g calc ulate d after e xtra -vasc ular 
a d mi nistrati o n
C R F
Case Re p ort F or m
C R U
Cli nical Researc h U nit
C S R
Cli nical St u d y  Re p ort
C V
C oefficie nt of variat i on
E C G
Electr ocar di o gra m
I C F
I nf or me d c o nse nt f or m
I C H
I nter nati o nal C o nfere nce o n Har m o nis atio n
I S R
I njecti on Si t e Reactio n
L L O Q
L o wer li mit of q ua nt ificati on
Me d D R A
Me dical Dict i onar y f or Re g ulat or y  Acti vities
P K
P har mac o ki net ic
S A E
S eri o us A d verse E ve nt
S A P
Stati stical 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


Fi nal v 1 , 1 5 Oct 2 0 2 0
             Pa ge 5 of 1 7
Stati stical A nal ysis Pla n 
C O N FI D E N TI A L
C o va nce Cli nical St u d y  N o. 1 0 0 0 0 7 1 - 8 4 5 4 0 7 0
S p o ns or Refere nce J 2 Z-M C -P G A B 
S C
S u bc uta ne o us
S D
Sta n dar d de viat i on 
t1/ 2
Half -life ass ociate d wit h t he ter mi nal rate c o nsta nt ( λz) i n 
n o n -c o m part me ntal a nal ysis
T B L
T ot al  bilir u bi n
T E A D A
Treat me nt -e mer ge nt a nt i dr u g a nti b o dies
T E A E
Treat me nt -e mer ge nt a d verse e ve nt
T F Ls
Ta bles, Fi g ures, a n d List i n gs
tlast
Ti me o f t he last o bser ve d dr u g c o nce ntrati o n
tma x
Ti me o f ma xi m u m o bser ve d dr u g c o nce ntrati o n
U L N
U p per li mit of n or mal
V A S
V is ual anal o g scale
V z/ F
A p pare nt v ol u me o f di stri b uti on d uri n g t he ter mi nal p hase after 
e xtra-vasc ular a d mi nistrati o n
W H O
W o rld Heal t h Or ga nizati on


Fi nal v 1 , 1 5 Oct 2 0 2 0
             Pa ge 6 of 1 7
Stati stical A nal ysis Pla n 
C O N FI D E N TI A L
C o va nce Cli nical St u d y  N o. 1 0 0 0 0 7 1 - 8 4 5 4 0 7 0
S p o ns or Refere nce J 2 Z-M C -P G A B 
3. I N T R O D U C TI O N
T his S A P has bee n de vel o pe d after re vie w of t he Cli nical St u d y Pr ot oc ol (fi nal versio n date d 
3 0 Se pte m ber 2 0 2 0 ).
T his S A P descri bes t he pla n ne d a nal ysis o f t he safet y, t olera bilit y, a n d p har mac o ki net ic (P K )
data fr o m  t his st u d y. A detaile d descri pt i on of t he pla n ne d T F Ls t o be prese nte d i n t he cli ni cal 
st u d y re p ort ( C S R) is pr o vide d i n t he acc o m pa n yi n g T F L s hell d oc u me nt.
T he i nte nt of t his d oc u me nt is t o pr o vi de g ui da nce f or t he statist ical a n d P K a nal yses of data. I n
ge neral, t he a nal yses are base d o n i nf or mat i on fr o m t he pr ot oc ol, u nless t he y ha ve bee n mo difie d 
b y a gree me nt wit h El i Lill y  a n d C o mpa n y . A li mite d a mo u nt of i nf or mati o n c o ncer ni n g t his 
st u d y (e. g., o bject i ves, st u d y desi g n) is gi ve n t o hel p t he rea der’s int er pretatio n . W he n t he S A P 
a n d T F L s hells are a gree d u p o n a n d fi nalize d, t he y will ser ve as t he te m plate f or t his st u d y’s 
C S R.
T his S A P s u perse des t he statist ical c o nsi derati ons i de ntifie d i n t he pr ot oc ol; w here 
c o nsi derati o ns are s u bsta nt iall y differe nt, t he y will be s o ide nt ifie d. If a d diti on al  a nal yses are 
re q uire d t o s u p ple me nt t he pla n ne d a nal yses descri be d i n t his S A P, t he y ma y be perf or me d a n d 
will be i de nt ifie d i n t he C S R. A n y s u bsta ntial de viati o ns fr o m t his S A P will be a gree d u p o n wi t h
Eli Lill y a n d C o mp a n y a n d i de nt ifie d i n t he C S R. A n y mi n or de viat i ons fr om t he T F Ls ma y not 
be d oc u m e nte d i n t he C S R.
T his S A P is writte n wit h c o nsi derati o n of t he rec o m me n dat i ons o utli ne d i n t he I nte r nati o nal 
C o nfere nce o n Har m o nis at i on (I C H) E 9 G ui deli ne e ntit le d G ui da nce f or I n d ustr y : Stati stical 
Pri nci ples f or Cli nical Trials 1 a n d t he I C H E 3 G ui deli ne e nt itle d G ui da nce f or I n d ustr y: 
Str uct ure a n d C o nte nt of Cli nical St u d y  Re p orts2.
4. S T U D Y O B J E C TI V E S
4. 1
Pri m ar y O bjecti ve
T he pri mar y  o bjecti ve of t he st u d y is to dete r mi ne t he P K of si n gle s u bc uta ne o us (S C ) d oses of 
L Y 3 8 3 2 4 7 9 i n healt h y part ici pa nts.
T he pri mar y  e n d p oi nts of t he st u d y are t he area u n der t he c o nce ntrati o n vers us ti me c ur ve fr o m 
ti me zer o t o i nfi nity (A U C [ 0-∞] ) a n d t he ma xi m u m o bser ve d dr u g c o nce ntrati o n ( C ma x ).
4. 2
Sec o n d ar y O bjecti ve
T he sec o n dar y  o bjecti ve of t he st u d y is to descri be safet y a n d t olera bilit y fol l owi n g si n gle S C 
d oses of L Y 3 8 3 2 4 7 9 i n healt h y partici pa nts .
T he sec o n dar y  e nd p oi nts of t he st u d y  are:

Inci de nce of s p o nta ne o usl y re p or te d a d verse e ve nts ( A Es ), treat me nt -e mer ge nt a d verse 
e ve nts (T E A Es ), a n d serio us a d verse e ve nts (S A Es )


Fi nal v 1 , 1 5 Oct 2 0 2 0
             Pa ge 7 of 1 7
Stati stical A nal ysis Pla n 
C O N FI D E N TI A L
C o va nce Cli nical St u d y  N o. 1 0 0 0 0 7 1 - 8 4 5 4 0 7 0
S p o ns or Refere nce J 2 Z-M C -P G A B 

vit al si g ns

cli nical la b orat or y res ults.
4. 3
E x pl or at or y O bjecti ves
T he e x pl orat or y  o bject i ves a n d e n d p o i nts of  t he st u d y are:

T o assess i njecti on site reactio ns ( I S Rs) f oll owi n g si n gle S C d oses of L Y 3 8 3 2 4 7 9 i n 
healt h y partici pa nts
o
C haracterizati o n a n d meas ure me nt of i nci de nce a n d se verit y of  I S Rs (i ncl u di n g 
i njecti on site pai n) usi n g data c ollecte d fr o m t he I S R assess me nt, as well as t he 
e x pl orat or y t o ol ( Scarletre d)

T o deter mi ne t he i m m u n o ge nicit y of  L Y 3 8 3 2 4 7 9 f oll o wi n g si n gle S C d oses i n health y 
parti ci pa nts.
o
I nci de nce of treat me nt-e mer ge nt a nt i dr u g a nti b o dies ( T E A D A)
5. S T U D Y D E SI G N
T his is a si n gle -sit e st u d y in healt h y partici pa nts w h o will recei ve a si n gle S C d ose of 
L Y 3 8 3 2 4 7 9. T he st u d y  will be partici pa nt - a n d i n vesti gat or -bli n de d, ra n d o mize d, a n d place b o
c o ntr olle d .
U p t o 2 c o h orts ma y be e nr olle d wit h at l east 9 partici pa nt s per c o h ort 
( 7 L Y 3 8 3 2 4 7 9 : 2 place b o), wit h t he i nte nt i on t hat at l east 6   partici pa nts ra n d o mize d t o 
L Y 3 8 3 2 4 7 9 ha ve s ufficie nt e val ua ble data i n eac h c o h ort.
P arti cipa nts will be scree ne d wit hi n 1 4 da ys pri or t o Da y  1 of d osi n g f or eac h c o h ort. 
P arti cipa nts will be a d mitte d t o t he cli nical researc h u nit (C R U ) as part of a n i n p atie nt visit o n 
D a y  -1 a n d will be se q ue nt iall y e nr olle d a n d t he n ra n d omize d t o treat me nt.
P arti cipa nts will be a d mitte d t o t he st u d y  site o n Da y -1. T he y  will re mai n i n patient  u ntil 
di sc har ge o n Da y 7 after st u d y pr oce d ures are c o m plete.
D osi n g will occ ur o n Da y  1. I nte n de d d oses of L Y 3 8 3 2 4 7 9 are as f oll o ws:

C o h ort 1: 3 5 0 m g

C o h ort 2: 1 0 0 0 m g
P arti cipa nts will u n der g o P K sa m pli n g a n d safet y assess me nt after d osi n g.
F or C o h ort 1, a safet y re vie w will be c o n d ucte d t o deter mi ne w het her it is a p pr o priate t o procee d 
wi t h d osi n g of t he ne xt c o h ort. T his safety re vie w will be c o n d ucte d base d o n data fr om at least 
5 partici pa nts, after at least 4 da ys after d osi n g. 


Fi nal v 1 , 1 5 Oct 2 0 2 0
             Pa ge 8 of 1 7
Stati stical A nal ysis Pla n 
C O N FI D E N TI A L
C o va nce Cli nical St u d y  N o. 1 0 0 0 0 7 1 - 8 4 5 4 0 7 0
S p o ns or Refere nce J 2 Z-M C -P G A B 
O n Da ys 1 t hr o u g h 7, partici pa nts will u n der g o P K sa m pli n g a n d safet y assess me nt .
A ge neral sc he ma f or t his st u d y ca n be see n i n Fi g ure 1 .
A b bre viati o ns: L Y = L Y 3 8 3 2 4 7 9; P B O = place b o .
Fi g ure 1 – Ge ner al sc he m a f or P G A B
6. T R E A T M E N T S
T he f o ll owi n g i s a list of t he st u d y tr e at me nt a b bre viat i ons t hat will be use d i n t he T F Ls.
C o h ort
St u d y Tre at me nt N a me
Tre at me nt or der i n T F L
All
P lace b o S C
1
1
3 5 0 m g L Y 3 8 3 2 4 7 9 S C
2
2
1 0 0 0 m g L Y 3 8 3 2 4 7 9 S C
3
7. S A M P L E SI Z E J U S TI FI C A TI O N
A ma xi m u m of 2 2 partici pa nts will be e nr o lle d t o st u d y int er ve nt i on wi t h t he i nte nt i on t hat at 
least 6  partici pa nts ra n d omize d t o L Y 3 8 3 2 4 7 9 ha ve s ufficie nt e val ua ble data i n eac h c o h ort .
T he sa m ple size is n ot p o were d o n t he basis o f statistical h y p ot hesis testi n g. H o we ver, base d o n 
a n ass u m pti o n o f 4 0 % c o efficie nt of variat i on (C V % ) f or bet wee n s u bject varia bility i n a P K 
para m eter of i nterest, 6 partici pa nt s o n active treat me nt per c o h ort ma y pr o vi de a p pr o xi matel y  
7 0 % c ha nce t o e ns ure t hat a P K para meter’s 9 0 % c o nfi de nce i nter val ( CI) falls withi n ( 0. 7, 1. 4 3) 
o ver t he c orres p o n d i n g ge o metric mea n, s uc h as A U C ( 0-∞) .
8. D E FI NI TI O N O F A N A L Y SI S P O P U L A TI O N S
T he “ E ntere d” p o p ulati o n will c o nsist of all part ici pa nts w h o si g ne d t he i nf or me d c o nse nt f or m 
(I C F).
T he “ E n r olle d / I nte nt-t o-Treat ” p o p ulat i on will c o nsist of a ll partici pa nts assi gne d t o treat me nt, 
re gar dless of w het her t he y recei ve d st u d y tr e at me nt, or if t he y t o o k t he c orrect treat me nt. 
P arti cipa nts will be a nal yze d acc or di n g t o t he treat me nt gr o u p t o w hic h t he y  were assi g ne d. 


Fi nal v 1 , 1 5 Oct 2 0 2 0
             Pa ge 9 of 1 7
Stati stical A nal ysis Pla n 
C O N FI D E N TI A L
C o va nce Cli nical St u d y  N o. 1 0 0 0 0 7 1 - 8 4 5 4 0 7 0
S p o ns or Refere nce J 2 Z-M C -P G A B 
T he “Safet y” p o p ulat i on will c o nsist of a ll participa nts ra n d o ml y  assi g ne d t o st u d y int er ve nt i on 
a n d w h o recei ve d st u d y int er ve ntio n. Parti ci pa nts will be a nal yze d acc or di n g t o t he i nter ve nt i on 
t he y act uall y recei ve d.
T he “ P har mac o ki net ic” p o p ulat i on will c o nsist of a ll treate d partici pa nts w h o recei ve d a f ull 
d ose of st u d y int er ve nt i on a n d ha ve s ufficie nt e val ua ble P K sa m ples. Parti ci pa nts w h o di d n ot 
recei ve a f ull d ose (fe wer i njecti o ns t ha n pla n ne d) w o ul d still ha ve t heir P K a nal yze d, b ut t he 
res ults will be re p orte d se paratel y a n d n ot i ncl u de d i n t he mai n a nal yses.
All pr ot oc ol de viat i ons t hat occ ur d uri n g t he st u d y will be c o nsi dere d f or t heir se verit y/ i m pact 
a n d will be ta ke n i nt o c o nsi derat i on w he n parti ci pa nt s are assi g ne d t o a nal ysis p o p ulat i ons.
9. S T A TI S TI C A L M E T H O D O L O G Y
9. 1
Ge ner al
Data list i n gs will be pr o vi de d f or all data t hat is data base d . S u m mar y  statistics a n d statistical 
a nal ysis will o nl y be prese nte d f or data w here detaile d i n t his S A P . F or c o nti n u o us data, 
s u m mar y statistics will i ncl u de t he arit h met ic mea n, arit h metic sta n dar d de viat i on ( S D) , me dia n, 
mi n, ma x a n d N; f or l o g -n or mal data (e. g. t he P K para meters: A U Cs a n d C ma x) t he ge o metric 
mea n a n d ge o m etric C V % will als o be prese nte d . F or cate g orical data, fre q ue nc y c o u nt a n d 
perce nta ges will be prese nte d . Data list i n gs will be pr o vi de d f or all part ici pa nts u p t o t he p oi nt of 
wi t hdra wal , wit h a n y part ici pa nts e xcl u de d fr om t he rele va nt p o p ulat i on hi g hli g hte d . S u m mar y 
statistics a n d statistical a nal yses will ge nerall y o nl y be perf or me d f or partici pa nt s i ncl u de d i n t he 
r ele va nt a nal ysis p o p ulat io n . F or t he calc ulat i on of s u m mar y  statistics a n d statistical a nal ysis, 
u nr o u n de d data will be use d. 
Mea n c ha n ge fr o m baseli ne is t he mea n of all i n di vi d ual p arti ci pa nt s’ c ha n ge fr om baseli ne 
val ues . Eac h i n di vi d ual c ha n ge fr o m baseli ne will be calc ulate d b y s u btractin g t he i n di vi d ual 
parti ci pa nt ’s baseli ne val ue fr om t he val ue at t he ti me p o i nt. T he i n di vi d ual part ici pa nt’s c ha n ge 
fr om baseli ne val ues will be use d t o calc ulate t he mea n c ha n ge fr o m baseli ne usi n g a S A S 
pr oce d ure s uc h as Pr oc U ni variate.
Dat a a nal ysis will be perf or me d usi n g S A S ® Versi o n 9. 4 or greater.
9. 2
De m o gr a p hics a n d P artici p a nt Dis p ositi o n
P arti cipa nt dis p osit i on will be s u m marize d a n d liste d. T he de m o gra p hic varia bles a ge, se x, race, 
et h nicit y , b o d y  wei g ht, hei g ht a n d b o d y mass i n de x will be s u m marize d a n d liste d . All ot her 
d e m o gra p hic vari a bles will be liste d o nl y.
9. 3
P h ar m ac o ki netic Assess me nt
9. 3. 1
P h ar m ac o ki netic A n al ysis
N o nc o m part me nt al met h o ds a p plie d wit h a vali date d s oft ware pr o gra m, P h oe ni x Wi n N o nli n 
( Certara, Versi o n 8. 1 or later) t o t he ser u m c o nce ntrati o ns of L Y 3 8 3 2 4 7 9 will be use d t o 
deter mi ne t he f oll o wi n g P K para meters, w he n p ossi ble:


Fi nal v 1 , 1 5 Oct 2 0 2 0
             Pa ge 1 0 of 1 7
Stati stical A nal ysis Pla n 
C O N FI D E N TI A L
C o va nce Cli nical St u d y  N o. 1 0 0 0 0 7 1 - 8 4 5 4 0 7 0
S p o ns or Refere nce J 2 Z-M C -P G A B 
P ar a meter
U n its a
Defi niti o n
A U C( 0 -∞)
µ g * da y / m L
A r ea u n der t he c o nce ntrati o n vers us ti me c ur ve fr o m ti me zer o t o 
i nfi nit y
% A U C(t
last-)
%
P er ce nta ge of A U C( 0 -∞) e xtra p olate d
A U C( 0 -tlast)
µ g * da y / m L
A r ea u n der t he c o nce ntrati o n vers us ti me c ur ve fr o m ti me zer o t o 
ti me t, w here t is t he last ti me p oi nt wit h a meas ura ble 
c o nce ntrati o n
C ma x
µ g/ m L
M a xi m u m o bser ve d dr u g c o nce ntrati o n
t½
da y
H alf-life ass ociate d wit h t he ter mi nal rate c o nsta nt ( λz) i n 
n o n -c o m part me ntal a nal ysis
tlast
da y
Ti me of t he last o bser ve d dr u g c o nce ntrati o n
tma x
da y
Ti me of ma xi m u m o bser ve d dr u g c o nce ntrati o n
C L/ F
L/ da y
A p pare nt t otal b o d y cleara nce of dr u g calc ulate d after 
e xtra -vasc ular a d mi nistrati o n
V z/ F
L
A p pare nt v ol u me of distri b uti o n d uri n g t he ter mi nal p hase after 
e xtra -vasc ular a d mi nistrati o n
V ss/ F
L
A p pare nt v ol u me of distri b ut i o n at stea d y state after 
e xtra -vasc ular a d mi nistrati o n
a U n its of s o urce L Y 3 8 3 2 4 7 9 ser u m c o nce ntrati o n data will be n g/ m L, t o o ne deci mal place.
A d dit i onal P K para meters ma y  be calc ulate d, as a p pr o priate. T he s oft ware a n d versi o n use d f or 
t he fi nal a nal yses will be s pecifie d i n t he cli nical st u d y re p ort. A n y e xce pt i ons or s pecial 
ha n dli n g of data will be clearl y d oc u me nte d wit hi n t he fi nal st u d y  re p ort.
F or matti n g of ta bles, fi g ures a n d a b bre viat i ons will f o ll o w t he Eli Lill y Gl o bal P K/ P D/ T S T o ol: 
N O N -C O M P A R T M E N T A L P H A R M A C O KI N E TI C S T Y L E G UI D E . T he versi o n of t he t o ol 
effect i ve at t he ti me of P K a nal ysis will be f oll ow e d.
Ge ner al P K P ar a meter R ules

Act ual  sa m pli n g ti mes will be use d i n t he fi nal a nal yses of i n di vi d ual P K para meters, 
e xce pt f or n o n-b ol us pre -d ose sa m pli n g ti mes w hic h will be set t o zer o.

C ma x a n d t ma x will be re p orte d fr o m o bser ve d val ues. W he n re p orti n g u nit -tra nsf or me d 
i n di vi d ual Cma x val ues (a n d t he c orres p o n di n g mi n i m u n, me d ia n, a n d ma x i m u m val ues) 
t he origi nal si g nifica nce will be mai ntai ne d (e g 1 2 3 4 5. 6 n g/ m L bec o me s 1 2 3. 4 5 6 µ g/ m L; 
ot her s u m mar y  statistics will be r o u n de d t o 3 si g nifica nt di gits ). If Cma x occ urs at m or e 
t ha n o ne ti me p oi nt, tma x will be assi g ne d t o t he first occ urre nce of C ma x . 

A U C para meters will be calc ulate d usi n g a c o m bi nati o n of t he li near a n d l o garit h m ic 
tra pez oidal met h o ds (li near -l og tra pez oi d al  r ule). T he li near tra pez oid al  met h o d will be 
a p plie d u p t o t ma x a n d t he n t he l o garit h mic tra pez oi dal met h o d will be use d after t ma x . T he 
mi ni m u m re q uire me nt f or t he calc ulat i on of A U C will be t he i ncl usi o n of at least t hree 
c o nsec ut i ve ser u m c o nce ntrati o ns a b o ve t he l ower li mi t of q ua ntificati on ( L L O Q ), wit h at 
least o ne of t hese c o nce ntrati o ns f oll owi n g C ma x. A U C( 0-) values w here t he perce nta ge 


Fi nal v 1 , 1 5 Oct 2 0 2 0
             Pa ge 1 1 of 1 7
Stati stical A nal ysis Pla n 
C O N FI D E N TI A L
C o va nce Cli nical St u d y  N o. 1 0 0 0 0 7 1 - 8 4 5 4 0 7 0
S p o ns or Refere nce J 2 Z-M C -P G A B 
of  t he t otal area e xtra p olate d is more t ha n 2 0 % will be fla g ge d. A n y A U C( 0 -) value 
e xcl u de d fr o m s u m mar y st atistics will be n ote d i n t he f o ot n ote of t he s u m mar y ta ble.

Half -life (t½ ) will be calc ulate d, w he n a p pr o priate, base d o n t he a p pare nt ter mi nal 
l og -li near p orti o n of t he c o nce ntrati o n-ti me c ur ve. T he start of t he ter mi nal eli mi nati on 
p hase f or eac h parti ci pa nt will be defi ne d b y vis ual i ns pect i on a n d ge nerall y will be t he 
first p oi nt at w hic h t here is n o s yst e mat ic de viati on fr o m t he lo g -li near decli ne i n ser u m 
c o nce ntrati o ns. Half-life will o nl y be calc ulate d w he n a relia ble esti mate f or t his 
para m eter ca n be o btai ne d c o m prisi n g o f at least 3 data p oi nts. If t ½ is esti mate d o ver a 
ti me wi n d o w of less t ha n 2 half -li ves, t he val ues will be fla g ge d i n t he data list i n gs. A n y 
t½ val ue e xcl u de d fr o m s u m mar y statist ics will be d oc u me nte d i n t he f o ot n ote of t he 
s u m mar y ta ble. 

A u nif or m wei g ht i n g sc he me will be use d i n t he re gressio n  a nal ysis of t he ter mi nal 
l og -li near p orti o n of t he c o nce ntrati o n-ti me c ur ve.

T he para meters base d o n pre dicte d C last will be re p orte d.
I n di vi d u al P K P ar a meter R ules

O nl y q ua ntifia ble c o nce ntrati o ns will be use d t o calc ulate P K Para meters wit h t he 
e xce pti o n of s pecial ha n dli n g of certai n c o nce ntrati o ns re p orte d bel o w t he l o wer li mit of  
q ua nt ificat i on ( B Q L). Ser u m c o nce ntrati o ns re p orte d as B Q L will be set t o a val ue of 
zer o w he n all of t he f o ll owi n g c o n di tio ns are m et: 
o
T he c o m p o u n d is n o n -e n d o ge n o us.
o
T he sa m ples are fr o m t he i nit ial d ose perio d f or a parti ci pa nt or fr o m a s u bse q ue nt
d ose peri o d f ol l owi n g a s ui ta ble was h-o ut peri o d.
o
T he ti me p oi nts occ ur bef ore t he first q ua nt ifia ble c o nce ntrati o n.

All ot her B Q L c o nce ntrati o ns t hat d o n ot meet t he a b o ve criteria will be set t o missi n g. 

Als o, w here t w o or m ore c o nsec ut i ve c o nce ntrati ons are B Q L t o war ds t he e n d of a 
pr ofile, t he pr ofile will be dee me d t o ha ve ter mi nate d a n d t heref ore a n y f urt her 
q ua nt ifia ble c o nce ntrati o ns will be set t o missi n g f or t he calc ulati on of t he P K para meters 
u nless it i s c o nsi dere d t o be a tr ue c haracteristic of  t he pr ofile of t he dr u g.
I n di vi d u al C o nce ntr ati o n vs. Ti me Pr ofiles

I n di vi d ual c o nce ntrati o ns will be pl otte d utilizi n g act ual sa m pli n g ti mes.

T he ter mi nal p o i nt select i ons will be i n dicate d o n a se mi -l og ari t h mic plot.


Fi nal v 1 , 1 5 Oct 2 0 2 0
             Pa ge 1 2 of 1 7
Stati stical A nal ysis Pla n 
C O N FI D E N TI A L
C o va nce Cli nical St u d y  N o. 1 0 0 0 0 7 1 - 8 4 5 4 0 7 0
S p o ns or Refere nce J 2 Z-M C -P G A B 
A ver a ge C o nce ntr ati o n vs. Ti me Pr ofiles

T he a vera ge c o nce ntrati o n pr ofiles will be gra p he d usi n g sc he d ule d ( n o mi nal) sa m pli n g 
ti mes. 

T he a vera ge c o nce ntrati o n pr ofiles will be gra p he d usi n g arit h met ic a vera ge 
c o nce ntrati o ns.

T he pre -d ose a vera ge c o nce ntrati o n f or si n gle -d ose data fr o m  n on -e n d o ge n o us 
c o mp o u n ds will  be set t o zer o. Ot her wise, o nl y q ua ntifia ble c o nce ntrati o ns will be use d 
t o calc ulate a vera ge c o nce ntrati o ns.

C o nce ntrati o ns at a sa m pli n g ti me e xcee di n g t he sa m pli n g ti me wi n d o w s pecifie d i n t he 
pr ot oc ol , or ± 1 0 %, will be e xcl u de d fr o m  t he a vera ge c o nce ntrati o n pr ofiles.

C o nce ntrati o ns e xcl u de d fr o m t he mea n calc ulati o n will be d oc u me nte d i n t he fi nal st u d y  
re p ort.

A c o nce ntrati o n a vera ge will be pl otte d f or a gi ve n sa m pli n g ti me o nl y  if 2/ 3 of t he 
i n di vi d ual data at t he ti me p oi nt ha ve q ua nt ifia ble meas ure me nts t hat are wit hi n t he 
sa m pli n g ti me wi n d o w s pecifie d i n t he pr ot oc ol or ± 1 0 %. A n a vera ge c o nce ntrati o n 
esti mate d wit h less t ha n 2/ 3 b ut m ore t ha n 3 data p oi nts ma y be dis pla ye d o n t he mea n 
c o nce ntrati o n pl ot if deter mi ned t o be a p pr o pri ate a n d will be d oc u me nte d wit hi n t he 
fi nal st u d y re p ort.
Tre at me nt of O utliers d uri n g P h ar m ac o ki netic A n al ysis
A p plicat i on of t his pr oce d ure t o all P K a nal yses is n ot a re q uire me nt. Rat her, t his pr oce d ure 
pr o vi des j ust ificati o n f or e xcl usio n  of data w he n scie ntificall y a p pr o priate. T his pr oce d ure 
descri bes t he met h o d ol o g y  for i de nt if yi n g a n i n di vi d ual val ue as a n o utlier f or p ote ntial 
e xcl usi o n, b ut d oes n ot re q uire t hat t he val ue be e xcl u de d fr o m a nal ysis.  T he f o ll owi n g 
met h o d ol o g y  will not be use d t o e xcl u de c o m plete pr ofiles fr o m a nal ysis.
Data wi t hi n a n I n di vi d ual Pr ofile
A val ue wit hi n a n i n di vi d ual pr ofile ma y be e xcl u de d fr o m a nal ysis if a n y of t he f o ll owi n g 
criteria are met:

F or P K pr ofiles d uri n g m ult i ple d osi n g, t he c o nce ntrati o n of  t he pre-d ose sa m ple e xcee ds 
all meas ure d c o nce ntrati o ns f or t hat i n di vi d ual  in t he s u bse q ue nt p ost -d ose sa m ples.

F or P K pr ofiles d uri n g si n gle d osi n g of n o n -e n d o ge n o us c o m p o u n ds, t he c o nce ntrati o n i n 
a pre-d ose sa m ple is q ua nt ifia ble.

F or a n y  q uesti ona b le dat u m t hat d oes n ot satisf y t he a b o ve crit eria, t he pr ofile will be 
e val uate d a n d res ults re p orte d wit h a n d wit h o ut t he s us pecte d dat u m. 


Fi nal v 1 , 1 5 Oct 2 0 2 0
             Pa ge 1 3 of 1 7
Stati stical A nal ysis Pla n 
C O N FI D E N TI A L
C o va nce Cli nical St u d y  N o. 1 0 0 0 0 7 1 - 8 4 5 4 0 7 0
S p o ns or Refere nce J 2 Z-M C -P G A B 
Data bet wee n I n di vi d ual Pr ofiles
1.
If n < 6, t he n t he dataset is t o o s mall t o c o n d uct a relia ble ra n ge test. Data will be a nal yze d 
wi t h a n d wit ho ut t he at y pical val ue, a n d b ot h sets of res ults will be re p orte d.  
2.
If n 6, t he n a n o bject i ve o utlier test will be use d t o c o m pare t he at y pical val ue t o ot her 
val ues i ncl u de d i n t hat calc ulat i on:
a.
Tra nsf or m all val ues i n t he calc ulati o n t o t he l o garit h mic d o mai n.
b.
Fi n d t he m ost e xtre m e val ue fr o m t he arit h metic mea n of t he lo g tra nsf or me d 
val ues a n d e xcl u de t hat val ue fr o m t he dataset.
c.
Calc ulate t he l o w er a n d u p per b o u n ds of t he ra n ge defi ne d b y t he arit h met ic 
mea n ± 3 * S D of t he re mai ni n g l o g -tra nsf or me d val ues.
d.
If t he e xtre me val ue is wit hi n t he ra n ge of arith metic mea n ± 3 * S D, t he n it is 
n ot a n o utlier a n d will be retai ne d i n t he dataset.
e.
If t he e xtre me val ue is o utsi de t he ra n ge of arit h metic mea n ± 3 * S D, t he n it is 
a n o utlier a n d will be e xcl u de d fr o m a nal ysis.
If t he re mai ni n g dataset c o ntai ns a n ot her at ypi c al  d at u m s us pecte d t o be a n o utlier a n d n ≥ 6 
f oll owi n g t he e xcl usi o n, t he n re peat ste p 2 a b o ve. T his e val uat i on ma y be re peate d as ma n y 
ti mes as necessar y, e xcl u di n g o nl y o ne s us pecte d o utlier i n eac h iterati o n, u ntil all data 
r e mai ni n g i n t he dataset fall wit hi n t he ra n ge o f arit h met ic mea n ± 3 * S D of t he l o g -tra nsf or me d 
val ues.
Re p orti n g of E xcl u de d Val ues
I n di vi d ual val ues e xcl u de d as o utliers will be d oc u me nte d i n t he fi nal re p ort. A p pr o val of t he 
fi nal re p ort will c o n n ote a p pr o val of t he e xcl usi on.
9. 3. 2
P h ar m ac o ki netic St atistic al Met h o d ol o g y
All P K  para meters will be s u m marize d b y treat me nt. Pl ots of t he pri mar y P K para meters 
(A U C[ 0 -∞], A U C[ 0-tlast], a n d Cm a x ) b y treat me nt will als o be pr o vi de d. A d diti o nall y, ser u m 
c o nce ntrati o ns will be gra p hicall y prese nte d b y tr e at me nt o ver ti me. 
9. 4
S afet y a n d T oler a bilit y Assess me nts
9. 4. 1
A d verse e ve nts
W here c ha n ges i n s e verit y are rec or de d i n t he Case Re p ort F or m ( C R F), eac h se parate se verity 
of  t he A E will be re p orte d i n t he listi n gs, o nl y t he m ost se vere will be use d i n t he s u m mar y 
ta bles. A pre -e xist i n g c o n diti on is defi ne d as a n A E t hat starts bef ore t he partici pa nt has pr o vi de d 
wri tte n i nf or me d c o nse nt a n d is o n g oi n g at c o nse nt . A n o n -treat me nt e mer ge nt A E is defi ne d as 
a n A E w hic h st arts aft er inf or me d c o nse nt b ut pri or t o d osi n g . A treat me nt -e mer ge nt A E is 


Fi nal v 1 , 1 5 Oct 2 0 2 0
             Pa ge 1 4 of 1 7
Stati stical A nal ysis Pla n 
C O N FI D E N TI A L
C o va nce Cli nical St u d y  N o. 1 0 0 0 0 7 1 - 8 4 5 4 0 7 0
S p o ns or Refere nce J 2 Z-M C -P G A B 
defi ne d as a n A E w hic h occ urs p ost d ose or w hi c h is prese nt pri or t o d osi n g a n d bec o mes m o re 
se vere p ost d ose. 
All A Es will be liste d . Treat me nt -e mer ge nt A Es will be s u m marize d b y treat me nt, se verit y a n d 
r elat i ons hi p t o t he st u d y  dr u g. T he fre q ue nc y (t he n u m ber of A Es , t he n u m ber of parti ci pa nt s 
e x perie nci n g a n A E a n d t he perce nta ge of parti ci pa nt s e x perie nci n g a n A E ) of 
treat me nt -e mer ge nt A Es will be s u m marize d b y treat me nt, Me dical Dicti o nar y f or Re g ulat or y  
Act i vities ( Me d D R A) versi on 2 3. 0 s yst e m or ga n class a n d preferre d ter m. T he s u m mar y a n d
fre q ue nc y A E ta bles will be prese nte d f or all ca usalities a n d t h ose c o nsi dere d relate d t o t he st u d y 
dr u g b y t he i n vest i gat or. A n y seri o us A Es will be liste d. 
Di sc o nti n uatio ns d ue t o A Es will be liste d.
9. 4. 2
C o nc o mit a nt me dic ati o n
C o nc o mita nt me dicat i on will be c o de d usi n g t he W H O dr u g dict i onar y  (Versi o n  Gl o b al B 3 
Marc h 2 0 2 0 ). C o nc o mita nt me dicati o n will be liste d.
9. 4. 3
Cli nic al l a b or at or y p ar a meters
All cli nical c he mistr y a n d he mat ol o g y data w ill be s u m marize d b y para meter a n d treat me nt , a n d 
liste d. Uri nal ysis da ta will be liste d. A d dit i onall y, cli nical c he mistr y, he mat olo g y  a n d uri nal ysis 
data o utsi de t he refere nce ra n ges will be liste d a n d fla g ge d o n i n di vi d ual part ici pa nt data list i n gs.
9. 4. 4
Vit al si g ns
Vi t al si g ns data will be s u m marize d b y treat me nt t o get her wit h c ha n ges fr o m baseli ne, w here 
baseli ne is defi ne d as t he D a y  1 pre d ose assess me nt . Fi g ures of mea n vital si g ns a n d mea n 
c ha n ges fr o m baseli ne pr ofiles will be prese nte d b y  tr e at me nt. 
V alu es f or i n di vi d ual p arti ci pa nt s will be liste d.
9. 4. 5
Electr oc ar di o gr a m ( E C G)
E C Gs will be perf or me d f or safet y m o nit ori n g p ur p oses o nl y a n d will n ot be prese nte d . A n y 
cli nicall y si g nifica nt fi n di n gs fr o m E C Gs will be re p orte d as a n A E.
9. 4. 6
He p atic M o nit ori n g
If a parti ci pa nt e x perie nces i ncreases i n ala ni ne a mi n otra nsferase ( A L T) , alkali ne p h os p hatase 
( A L P), or ele vate d t otal bilir u bi n ( T B L), a b o ve pre deter mi ne d s pecific t hres h o l ds, a d ditio nal  
i n vesti gati ons will be perf or m e d t o c o nfir m t he a b n or malit y a n d/ or searc h f or p ossi ble ca uses as 
i n dicate d i n Secti o n 8. 2. 5 of t he pr ot oc ol
W here a p plica ble, t he f o ll owi n g will be prese nte d :
T he parti ci pa nt s’ li ver disease hist or y a n d ass ociate d pers o n li ver disease hist or y data will be 
liste d. A n y c o nc o mit a nt me dicat i ons that ha ve p ote nt ial f or he pat ot o xicity,  incl u di n g 


Fi nal v 1 , 1 5 Oct 2 0 2 0
             Pa ge 1 5 of 1 7
Stati stical A nal ysis Pla n 
C O N FI D E N TI A L
C o va nce Cli nical St u d y  N o. 1 0 0 0 0 7 1 - 8 4 5 4 0 7 0
S p o ns or Refere nce J 2 Z-M C -P G A B 
aceta mi n o p he n will be liste d. Res ults fr o m a n y he patic m o nit ori n g pr oce d ures a n d bi o ps y 
assess me nt s will be liste d, if p erf or me d.
He pati c ris k fact or assess me nt data will be liste d . Li ver relate d si g ns a n d s y m pt o ms data will be 
s u m marize d b y tr e at me nt a n d liste d. Alc o h o l a n d r ecreatio nal dr u g use data will als o be liste d.
All he pat ic c he mistr y, he mat ol o g y, c oa g ulati on, a n d ser ol o g y  data will be liste d. Val ues o utsi de 
t he refere nce ra n ges will be fla g ge d o n t he i n di vi d ual parti ci pa nt data list i n gs.
9. 4. 7
I m m u n o ge nicit y Assess me nts
T he fre q ue nc y a n d perce nta ge of parti ci pa nt s wit h pre-e xist i n g a nti dr u g a nti b o d y ( A D A) a n d 
wi t h treat me nt -e mer ge nt A D As ( T E A D A) t o L Y 3 8 3 2 4 7 9 will be ta b ulate d a n d liste d. 
F or partici pa nt s w h o are A D A ne gati ve at baseli ne ( Da y 1 pre d ose), T E A D As are defi ne d as 
t hose wi t h a tit er 2-f ol d ( 1 dil uti o n) greater t ha n t he mi ni m u m re q uire d dil uti on of t he assa y  
( 1:1 0 ). F or partici pa nt s w h o are A D A p ositi ve at baseli ne, T E A D As are defi ne d as t h ose wit h a 
4 -f ol d ( 2 dil uti o n) i ncrease i n t iter c o m pare d t o baseli ne. T he fre q ue nc y a n d perce nta ge of 
parti ci pa nt s wit h cr oss-reactive a n d ne utralizi n g a nti b o dies, if meas ure d, ma y als o be ta b ulate d 
f or parti cipa nt s wit h T E A D A.
9. 4. 8
H y perse nsiti vit y re acti o ns
F or all dr u g h y perse nsit i vity r e a ctio ns t hat occ ur, a d di tio nal  f oll o w-u p data will be c o llecte d t o
assess t he patie nt ’s me dical hist or y, alter nati ve ca uses, a n d s y m pt o ms.
T hese data will be liste d.
9. 4. 9
I njecti o n-Site Re acti o ns
I njecti on site assess me nts usi n g t he I S R C R F, vi s u al a nalo g scale (V A S ) if re q uire d, a n d a n 
e x plor at or y  t o ol ( S c arletre d) will be perf or me d .
T he V A S is a well -vali date d t o ol ( Willia ms o n a n d H o g gart 2 0 0 5) t o assess i njecti o n site pai n; it 
is prese nte d as a 1 0 0-m m li ne a nc h ore d b y ver bal descri pt ors, us uall y “ n o pai n” a n d “ w orst 
i ma gi na ble pai n.” T he partici pa nt will be as ke d t o rate a n y pai n at t he i njecti on site o n a scale of 
0 t o 1 0 0 o n t he li ne, as s o o n as p ossi ble f o ll owi n g eac h i nject i on.


Fi nal v 1 , 1 5 Oct 2 0 2 0
             Pa ge 1 6 of 1 7
Stati stical A nal ysis Pla n 
C O N FI D E N TI A L
C o va nce Cli nical St u d y  N o. 1 0 0 0 0 7 1 - 8 4 5 4 0 7 0
S p o ns or Refere nce J 2 Z-M C -P G A B 
I n a d diti on, t he e x pl orat or y  t o ol ( S c arletre d) will be use d t o ac q uire e x pl orat or y I S R data at eac h 
of  t he ti me p oi nts w here t he I S R data is bei n g c ollecte d b y a d mi nistrati o n of t he I S R C R F.
Pai n V A S data will be s u m marize d, t o get her wit h c ha n ges fr o m baseli ne, b y  tr e at me nt a n d liste d. 
Baseli ne is defi ne d as t he assess me nt c ollecte d o n Da y  1 pre d ose. If pai n V AS was n ot c ollecte d 
at baseli ne, t he baseli ne val ue will be set t o 0. Pl ots of  b ot h o bser ve d a n d c ha n ge fr o m baseli ne 
pai n V A S data will b e pr o vi de d b y  tr e at me nt o ver ti me. T he rest of t he injecti o n -sit e r e a ctio n 
data (i ncl u di n g er yt he ma, i n d uratio n, pai n, pr uri t us, a n d e de ma) will be s u m marize d b y treat me nt 
i n fre q ue nc y ta bles, a n d liste d.
9. 4. 1 0
Se vere ac ute res pir at or y s y n dr o me c or o n a vir us 2 ( S A R S -C O V -2) i nfecti o n
Data fr o m S A R S -C o V -2 cli nical scree ni n g, ser ol o g y, a n d p o i nt-of -care test will be liste d, if 
a vaila ble.
9. 4. 1 1
Ot her assess me nts
All ot her safet y assess me nts n ot detaile d i n t his secti o n will be liste d b ut n ot s u m marize d or 
statisticall y a nal yze d.
9. 4. 1 2
S afet y a n d T oler a bilit y St atistic al Met h o d ol o g y
N o i nfere nt ial st atistical a nal yses are pla n ne d.
1 0.
I N T E RI M A N A L Y S E S
N o i nt eri m statistical a nal yses are pla n ne d.
1 1.
C H A N G E S F R O M T H E P R O T O C O L S P E CI FI E D S T A TI S TI C A L A N A L Y S E S
T here were n o c ha n ges fr o m t he pr ot oc ol s pecifie d statistical a nal yses.
1 2.
R E F E R E N C E S
1.
I nter nati o nal C o nfere nce o n Har m o nizati on of Tec h nical Re q uire me nts f or Re gistr atio n of  
P har mace ut icals f or H u ma n Use, I C H Har mo nize d Tri parti t e G uideli ne, Stati stical Pri nci ples 
f or Cli nical Trials ( E 9), 5 Fe br uar y 1 9 9 8.
2.
I nter nati o nal C o nfere nce o n Har m o nizati on of Tec h nical Re q uire me nts f or Re gistrati o n of 
P har mace ut icals f or H u ma n Use, I C H Har mo nize d Tri parti t e G uideli ne, Str uct ure a n d 
C o nte nt of Cli nical St u d y  Re p orts ( E 3), 3 0 N o ve m ber 1 9 9 5.
3.
Willia ms o n A, H o g gart B. Pai n: a re vie w o f t hree c o m m onl y  use d pai n rati n g scales. J Cli n 
N urs. 2 0 0 5; 1 4( 7): 7 9 8 -8 0 4


Fi nal v 1 , 1 5 Oct 2 0 2 0
             Pa ge 1 7 of 1 7
Stati stical A nal ysis Pla n 
C O N FI D E N TI A L
C o va nce Cli nical St u d y  N o. 1 0 0 0 0 7 1 - 8 4 5 4 0 7 0
S p o ns or Refere nce J 2 Z-M C -P G A B 
1 3.
D A T A P R E S E N T A TI O N
1 3. 1
Deri ve d P ar a meters
I n di vi d ual deri ve d para meters (e. g. P K para meters) a n d a p pr o priate s u m mar y statistics will be 
re p orte d t o t hree si g nifica nt fi g ures. O bser ve d c o nce ntrati o n data, e. g. C ma x , s h o uld be re p orte d 
as recei ve d . O bser ve d ti me d ata, e. g. t ma x , s h o ul d be re p orte d as recei ve d. N a n d perce nta ge 
val ues s h o ul d be re p orte d as w h ole n u m bers . Me dia n val ues s h o ul d be treate d as a n o bser ve d 
para m eter a n d re p orte d t o t he sa me n u m ber of deci mal places as mi ni m u m a n d ma xi m u m val ues.
1 3. 2
Missi n g D at a
Missi n g data will n ot be dis pla ye d i n list i n gs.
1 3. 3
I ns ufficie nt D at a f or Prese nt ati o n
S o m e of t he T F Ls ma y not ha ve s ufficie nt n u m bers of parti ci pa nt s or data f or prese ntati o n. If 
t his occ urs, t he bla n k T F L s hell will be prese nte d wit h a messa ge pri nte d in t he ce nter of  t he 
ta ble, s uc h as, “ N o seri o us a d verse e ve nts occ urre d f or t his st u d y . ”


L e o  D o c u m e n t  I D  =  7 4 d e d 0 6 e - 3 5 2 2 - 4 f 9 c - 8 3 e 9 - 4 c 9 0 2 d 8 4 5 d 8 b
A p p r o v e r :  
A p p r o v a l  D a t e  &  T i m e :  1 5 - O c t - 2 0 2 0  1 7 : 4 4 : 5 6  G M T
S i g n a t u r e  m e a n i n g :  A p p r o v e d
A p p r o v e r :  
A p p r o v a l  D a t e  &  T i m e :  1 5 - O c t - 2 0 2 0  2 0 : 5 2 : 0 2  G M T
S i g n a t u r e  m e a n i n g :  A p p r o v e d
A p p r o v e r :  
A p p r o v a l  D a t e  &  T i m e :  1 6 - O c t - 2 0 2 0  0 9 : 3 5 : 3 2  G M T
S i g n a t u r e  m e a n i n g :  A p p r o v e d
A p p r o v e r :  
A p p r o v a l  D a t e  &  T i m e :  1 6 - O c t - 2 0 2 0  1 5 : 3 8 : 1 8  G M T
S i g n a t u r e  m e a n i n g :  A p p r o v e d
P P D
P P D
P P D
P P D