Clinical trial NCT04441931
Conditions: Healthy
Sponsor: Eli Lilly and Company
Start date: 2020-06-19; Completion date: 2020-10-02
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The main purpose of this study is to learn more about the safety of LY3832479 and any side effects that might be associated with it. Blood tests will be done to measure how much LY3832479 is in the bloodstream and how long it takes the body to eliminate it. Participation could last up to 16 weeks and may include up to 10 visits to the study center.

Detailed description:

Arms: arm 1: Participants received single Intravenous (IV) doses of 700, 2800 and 7000 milligrams (mg) LY3832479. arm 2: Participants received single IV dose of Placebo.
Interventions: intervention 1: LY3832479 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered IV. intervention 2: Administered IV.

Protocol documents:
Prot_000.pdf: 
Pr ot oc ol : J 2 Z- M C- P G A A (c)
A P hase 1, Ra n d o mize d, Place b o- C o ntr olle d St u d y t o E val uate t he T olera bilit y, Safet y, 
P har mac o ki netics, a n d I m m u n o ge nicit y of L Y 3 8 3 2 4 7 9 Gi ve n as a Si n gle I ntra ve n o us D ose i n 
Healt h y Partici pa nts
N C T 0 4 4 4 1 9 3 1   
A p pr o val Date: 1 5-J ul- 2 0 2 0


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
1
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 el 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 P hase 1, Ra n d o mi ze d, Place b o -C o ntr olle d St u d y  t o E val uate t he T olera bility,  
S af et y,  P har mac o ki netics, a n d I m m u n o ge nicit y of L Y 3 8 3 2 4 7 9 Gi ve n as a Si n gle 
I ntra ve n o us D ose i n Healt h y Partici pa nts
Pr ot oc ol N u m ber: J 2 Z-M C -P G A A
A me n d me nt N u m ber: c
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 P hase 1, Ra n d o mize d, Place b o -C o ntr olle d St u d y  t o E valuate L Y 3 8 3 2 4 7 9 i n 
Heal t h y Partici 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(s)
Pre -I N D n u m ber : 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 t he date pr o vi de d 
bel o w.
A p pr o v al D at e: 1 5- J ul- 2 0 2 0 G M T


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
2
Medical Monitor Name and Contact Information will be provided separately.


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
3
Protocol Amendment Summary of Changes Table
DOCUMENT HISTORY
Document
Date
Original Protocol 
03-Jun-2020
Amendment (a)
23-Jun-2020
Amendment (b)
26-Jun-2020
Amendment (c)
Overall Rationale for the Amendment:
Language has been added throughout the protocol to allow for collection of additional swab 
samples, some of which may be used for research purposes. 
Section # and 
Name
Description of Change
Brief Rationale
Section 1.3 
(Schedule of 
Activities); 
Section 5.1
(Inclusion 
Criteria)
Added reference to post-
baseline nasal or 
nasopharyngeal swab. 
To facilitate analysis of postbaseline 
samples for research purposes.
Section 8.3.7, 
(SARS-Cov-2 
Infection);
Section 8.8 
(Biomarkers)
Added description of how 
and when post-baseline nasal 
or nasopharyngeal swab will 
be administered.
As above.
Section 10.2 
(Appendix 2: 
Clinical 
Laboratory Tests)
Added detail of how post-
baseline nasal or 
nasopharyngeal sample will 
be managed.
As above.


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
4
T a ble of C o nte nts
1.
Pr ot oc ol S u m m ar y ......................................................................................................7
1. 1.
S y n o psis .......................................................................................................................7
1. 2.
Sc he ma .........................................................................................................................8
1. 3.
Sc he d ule of Act i vities ( S o A) ........................................................................................9
2.
I ntr o d ucti o n ..............................................................................................................1 5
2. 1.
St u d y  Ratio nale ..........................................................................................................1 5
2. 2.
Bac k gr o u n d ................................................................................................................1 5
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 8
4.
St u d y Desi g n .............................................................................................................1 9
4. 1.
O verall Desi g n ............................................................................................................1 9
4. 1. 1.
Si n gle -Asce n di n g D ose Desi g n ...................................................................................1 9
4. 2.
S ci e nt ific Rati o nale f or St u d y Desi g n.........................................................................2 0
4. 3.
J ustificati o n f or D ose..................................................................................................2 0
4. 4.
E n d of St u d y  Defi niti on ..............................................................................................2 2
5.
St u d y P o p ul ati o n ......................................................................................................2 3
5. 1.
I ncl usi on Cri t eria ........................................................................................................2 3
5. 2.
E xcl u sio n  Crit eria .......................................................................................................2 3
5. 3.
Lifest yle C o nsi derat i ons .............................................................................................2 6
5. 3. 1.
Meals a n d Dietar y  Restrict i ons ...................................................................................2 6
5. 3. 2.
Caffei ne, Alc o h o l, a n d T o bacc o..................................................................................2 6
5. 3. 3.
Act i vity ......................................................................................................................2 6
5. 4.
Scree n Fail ures ...........................................................................................................2 6
6.
St u d y I nter ve nti o n ....................................................................................................2 7
6. 1.
St u d y  I nter ve nti ons A d mi nistere d ...............................................................................2 7
6. 1. 1.
I nf usi ons .....................................................................................................................2 8
6. 2.
Pre parati o n/ Ha n dli n g/ St ora ge/ Acc o u nta bilit y .............................................................3 0
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 ..........................................3 0
6. 4.
St u d y  I nter ve nti on C o m plia nce ...................................................................................3 1
6. 5.
C o nc o mita nt T hera p y ................................................................................................. 3 1
6. 6.
D ose M o dificat i on ......................................................................................................3 1
6. 6. 1.
D ose -Escal at i on Cri t eria .............................................................................................3 1
6. 6. 2.
Access t o Data d uri n g t he St u d y .................................................................................3 2
6. 6. 3.
T e m p orar y  St o p pi n g Crit eria ......................................................................................3 2
6. 7.
I nter ve nti o n after t he E n d of t he St u d y........................................................................3 2
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 3
7. 1.
Di sc o nti n uatio n of  St u d y I nter ve nti on ........................................................................3 3
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 3
7. 2. 1.
Di sc o nti n uatio n of  I na d verte ntl y Enr olle d Partici pa nts ...............................................3 3
7. 3.
L ost t o F oll o w - u p .......................................................................................................3 4
8.
St u d y A ssess me nts a n d Pr oce d ures .........................................................................3 5


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
5
8. 1.
Efficac y Assess me nts ................................................................................................. 3 5
8. 2.
S af et y Assess me nts ....................................................................................................3 5
8. 2. 1.
Vi tal Sig ns.................................................................................................................. 3 5
8. 2. 2.
Electr ocar di o gra ms .....................................................................................................3 5
8. 2. 3.
Cli nical Safet y  La b orat or y Assess me nts .....................................................................3 6
8. 2. 4.
He pati c M o nit orin g .....................................................................................................3 6
8. 3.
A d v erse E ve nts a n d Seri o us A d verse E ve nts ..............................................................3 8
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 8
8. 3. 2.
Met h o d of Detecti n g A Es a n d S A Es ...........................................................................3 9
8. 3. 3.
F o ll ow- u p of  A Es a n d S A Es.......................................................................................3 9
8. 3. 4.
Re g ulat or y  Re p orti n g Re q uire me nts f or S A Es............................................................3 9
8. 3. 5.
Pre g na nc y ...................................................................................................................3 9
8. 3. 6.
H y perse nsi tivi t y R e a ctio ns .........................................................................................4 0
8. 3. 7.
S A R S -C O V -2 I nfect i on ..............................................................................................4 0
8. 3. 8.
I nf usi on- Relate d Reacti o ns .........................................................................................4 1
8. 3. 9.
Pr o d uct C o m plai nt s ....................................................................................................4 1
8. 4.
Treat me nt of O ver d ose ...............................................................................................4 2
8. 5.
P har mac o ki net ics........................................................................................................4 2
8. 6.
P har mac o d y na mics .....................................................................................................4 2
8. 7.
Ge net ics .....................................................................................................................4 2
8. 8.
Bi o m ar kers .................................................................................................................4 2
8. 9.
I mm u n o ge nicit y Assess me nts .....................................................................................4 3
8. 1 0.
Heal t h Ec o n o mics.......................................................................................................4 3
9.
St atistic al C o nsi der ati o ns .........................................................................................4 4
9. 1.
Stati stical H y p ot heses................................................................................................. 4 4
9. 2.
S a m ple Si ze Deter mi nat i on .........................................................................................4 4
9. 3.
P o p ul at i ons f or A nal yses ............................................................................................4 4
9. 4.
Stati stical A nal yses .....................................................................................................4 4
9. 4. 1.
Ge neral C o nsi derati o ns ...............................................................................................4 5
9. 4. 2.
Pri mar y E n d p o i nts ( Safety) .........................................................................................4 5
9. 4. 3.
Sec o n dar y  E n d p oi nts ( P K) ..........................................................................................4 5
9. 4. 4.
Terti ar y/ E x pl orat or y E n d p oi nt (I m m u n o ge nicity) .......................................................4 5
9. 4. 5.
Ot her A nal yses ...........................................................................................................4 6
9. 5.
I nteri m A nal yses.........................................................................................................4 6
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 7
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 7
1 0. 1. 1.
Re g ulat or y  a n d Et hical C o nsi derati ons ........................................................................4 7
1 0. 1. 2.
I nf or me d C o nse nt Pr ocess ..........................................................................................4 7
1 0. 1. 3.
Data Pr otecti o n ...........................................................................................................4 8
1 0. 1. 4.
Di sse mi nati on of Cli nical St u d y  Data .........................................................................4 8
1 0. 1. 5.
Data Q ualit y Ass ura nce ..............................................................................................4 8
1 0. 1. 6.
S o urce D oc u me nts ......................................................................................................5 0
1 0. 1. 7.
St u d y  a n d Site Start a n d Clos ure .................................................................................5 0
1 0. 1. 8.
P u blicat i on P olic y .......................................................................................................5 1


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
6
1 0. 1. 9.
I n vesti gat or I nf or mati on .............................................................................................5 1
1 0. 1. 1 0. L o n g -Ter m  Sa m ple Rete nti on .....................................................................................5 1
1 0. 2.
A p pe n di x 2: Cli nical La b orat or y  Tests........................................................................5 2
1 0. 2. 1.
Bl o o d S a m pli n g S u m mar y ..........................................................................................5 5
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 6
1 0. 3. 1.
Defi nit i on of  A E.........................................................................................................5 6
1 0. 3. 2.
Defi nit i on o f S A E .......................................................................................................5 7
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 8
1 0. 3. 4.
Re p orti n g of S A Es ......................................................................................................5 9
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 ...............................................................................................6 1
1 0. 4. 1.
W o me n .......................................................................................................................6 1
1 0. 4. 2.
Me n ............................................................................................................................6 1
1 0. 4. 3.
C ollect i on of Pre g na nc y  I nfor m at i on ..........................................................................6 2
1 0. 5.
A p pe n di x 5: Ge netics ................................................................................................. 6 4
1 0. 6.
A p pe n di x 6:  Li ver Safet y:  S u g geste d Acti o ns a n d F oll o w-U p 
Assess me nts ...............................................................................................................6 5
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 7
1 0. 8.
A p pe n di x 8: A b bre viat i ons .........................................................................................6 9
1 1 .
Refere nces .................................................................................................................7 2


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
7
1.
Protocol Summary
1.1.
Synopsis
Protocol Title: A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Tolerability, 
Safety, Pharmacokinetics, and Immunogenicity of LY3832479 Given as a Single Intravenous 
Dose in Healthy Participants
Short Title: A Phase 1, Randomized, Placebo-Controlled Study to Evaluate LY3832479 in 
Healthy Participants
Rationale:
Lilly is developing LY3832479 for the treatment and prevention of coronavirus disease 2019
(COVID-19). Study J2Z-MC-PGAA (PGAA) will investigate the safety, tolerability, and 
pharmacokinetics of LY3832479 when administered as a single intravenous dose to healthy 
participants.
Objectives and Endpoints
Objectives
Endpoints
Primary

To investigate the safety and 
tolerability of a single dose of 
LY3832479 in healthy participants

Serious and nonserious adverse events, 
laboratory measures of safety, ECG, 
and vital signs
Secondary

To characterize the pharmacokinetics 
of LY3832479 following a single IV
administration of LY3832479 to 
healthy participants

AUC, Cmax
Abbreviations: AUC = area under the concentration versus time curve; Cmax = maximum observed drug 
concentration; ECG = electrocardiogram; IV = intravenous.
Overall Design
Study PGAA is a Phase 1, randomized, placebo-controlled study of LY3832479 administered to
healthy participants.
The study will comprise up to 3 cohorts, each with an intended number of participants as 
follows:
Cohorts 1 and 2
At least 9 participants:

7 randomized to LY3832479 and

2 randomized to placebo.


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
8
C o h ort 3
At  least 8 partici pa nts:

6 ra n d o mize d t o L Y 3 8 3 2 4 7 9 a n d

2 ra n d o mize d t o place b o.
P arti cipa nts will be i nit iall y mo ni t or e d for s af et y wit hi n t he st u d y sit e w here t he y  will be 
a d mitte d o n Da y -1, d ose d o n Da y  1, di sc har ge d o n Da y 4, a n d s u bse q ue ntl y m o nit ore d o n a n 
o ut pati e nt basis u nt il t he last f oll ow- u p visit .
Discl os ure St ate me nt : T hi s is a se q ue ntial, si n gle-asce n di n g d ose st u d y wit h u p t o 3 c o h orts t hat 
is partici pa nt a n d i n vesti gat or bli n de d.
N u m ber of P artici p a nt s:
A ma xi m u m of 3 0 partici pa nts will be e nr o lle d t o st u d y i nter ve nti on s uc h t hat a p pr o xi matel y 
8   partici pa nts ha ve s ufficie nt e val ua ble data i n eac h of  t he 3 c o h ort s. 
I nter ve nti o n Gr o u ps a n d D ur ati o n :
Si n gle -d ose st u d y  wit h a n esti mate d d urati o n f or eac h partici pa nt of u p t o 1 6 wee ks fr o m 
scree ni n g t hr o u g h f oll ow- u p.
D at a M o nit ori n g C o m mittee: N o
1. 2.
Sc he m a
A b bre viati o ns: L Y = L Y 3 8 3 2 4 7 9 ; P B O = place b o; P K = p har mac o ki netics.
N ote: After at least 7 partici pa nts ha ve c o m plete d Da y 4 i n a gi ve n c o h ort, all safet y data u p t o t his c ut off date 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 e nr olle 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 vesti gat or.
Fi g ure 1.
Si n gle -asce n di n g d ose sc he m a f or St u d y J 2 Z- M C -P G A A .
C o h ort 2
7 LY : 2 P B O
C o h ort 1
7 LY : 2 P B O
C o h ort 3
6 LY : 2 P B O
D os e L ev el 1
( 7 0 0 m g of LY or P B O)
D os e L ev el 2
( 2 8 0 0 m g of LY or P B O)
D os e L ev el 3
( 7 0 0 0 m g of LY or P B O)


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
9
1. 3.
Sc he d ule of Acti vities ( S o A)
Pr oce d ure / 
Assess me nts
Scree ni n g
D osi n g
P ost d ose 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  
V 7  
V 8  
V 9
V 1 0/
E D
Wee k(s)
0
1 
2 
3 
4 
6 
8 
1 0 
1 2
St u d y D a y
- 1 4
t o – 2
- 1 
1 
2 
3 
4 
8
± 1 d
1 5
± 2 d
2 2
± 2 d
2 9
± 3 d
4 3
± 3 d
5 7
± 3 d
7 1
± 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 ncl usi o n/e xcl usi o n 
criteria
X  
X
Pre d ose
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
C O VI D -1 9 cli nical 
scree ni n g
X  
X
X  
X  
X  
X  
X  
X  
X  
X
S y m pt o ms a n d rece nt 
c o ntact (see Secti o n 
8. 3. 7 f or a descri pti o n 
of s y m pt o ms a n d cl ose 
c o ntact). At scree ni n g, 
Da y -1 a n d as nee de d 
d uri n g t he st u d y. See 
Secti o n 4. 1 f or details.
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.


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
1 0
Pr oce d ure / 
Assess me nts
Scree ni n g
D osi n g
P ost d ose 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  
V 7  
V 8  
V 9
V 1 0/
E D
Wee k(s)
0
1 
2 
3 
4 
6 
8 
1 0 
1 2
St u d y D a y
- 1 4
t o – 2
- 1 
1 
2 
3 
4 
8
± 1 d
1 5
± 2 d
2 2
± 2 d
2 9
± 3 d
4 3
± 3 d
5 7
± 3 d
7 1
± 3 d
8 5
± 3 d
Nas al or nas o p har yn geal
s wa b
X
At scree ni n g, o nl y if 
S A R S -C o V -2 p oi nt -of -
care test will n ot be 
a vaila ble f or 
Da y - 1. P ost -baseli ne, 
a d diti o nal nasal or 
nas o p har y n geal s wa bs 
ma y  be c o n d ucte d f or 
researc h p ur p oses. See 
Secti o n 8. 3. 7 .
A d missi o n t o st u d y 
site/c hec k i n (a d missi o n 
da y m a y var y de pe n di n g 
o n I P a vaila bilit y)
X
If scree ni n g is 
c o n d ucte d wit hi n 3 da ys 
of c hec k -i n, p artici pa nts 
ma y  sta y at t he st u d y 
site bet wee n scree ni n g 
a n d c hec k i n. See 
Secti o n 4. 1 f or details.
S A R S -C o V -2 p oi nt -of -
care test
X
O n Da y - 1, if 
nasal/ nas o p har y n geal 
s wa b was n ot perf or me d 
at scree ni n g. 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 .
Disc har ge fr o m st u d y
site
X


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
11
Procedure / 
Assessments
Screening
Dosing
Postdose Follow-up Visits
Comment
Visit Number
V1
V2
V3
V4
V5
V6
V7
V8
V9
V10/
ED
Week(s)
0
1
2
3
4
6
8
10
12
Study Day
-14
to –2
-1
1
2
3
4
8
±1d
15
±2d
22
±2d
29
±3d
43
±3d
57
±3d
71
±3d
85
±3d
Physical examination
(PE)/Medical assessment
(MA)
X
X
Predose
X
As needed
X
Full PE/MA at 
screening and Visit 
10/ED. Symptom-
directed PE/MA at all 
other indicated time 
points and as deemed 
necessary by the 
investigator.
Vital signs: blood 
pressure, pulse ratea
X
X
Predose, every 
15 min during 
infusion; every 
30 min until 2h 
after end of 
infusion; then 
every 60 min 
until 6h after 
end of infusion.
24 h 
(±2 h)
48 h
(±2 h)
X
X
X
X
X
X
X
X
X
Vital signs should be 
taken following an at 
least 5-min rest in a 
supine position. Vital 
signs may be taken any 
time prior to dosing.
Body temperature
X
X
Predose, 6 h 
(±15 min)
24 h 
(±2 h)
May be performed at 
additional time points at 
the discretion of the 
investigator.
Single 12-lead ECGa
X
Predose, 
1 h (±10 min), 
6 h (±15 min)
24 h
(±2 h)
48 h
(±2 h)
X
X
X
X
All ECGs are local. 
Predose ECG can be 
taken any time prior to 
dosing on same day.


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
12
Procedure / 
Assessments
Screening
Dosing
Postdose Follow-up Visits
Comment
Visit Number
V1
V2
V3
V4
V5
V6
V7
V8
V9
V10/
ED
Week(s)
0
1
2
3
4
6
8
10
12
Study Day
-14
to –2
-1
1
2
3
4
8
±1d
15
±2d
22
±2d
29
±3d
43
±3d
57
±3d
71
±3d
85
±3d
Concomitant medications 
and AE review
X
X
Predose
X
X
X
X
X
X
X
X
X
X
X
AE only after 
participant has signed 
the study informed 
consent form.
HIV, hepatitis B/C 
serology
X
Pregnancy test (women 
only)b
X
X
Serum pregnancy test at 
screening. Day -1 urine 
test refers to test at 
check-in; this is not 
needed if check-in 
occurs on 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
Predose
X
X
X
X
X
X
X
X
Fasting is not required 
for these tests.


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
1 3
Pr oce d ure / 
Assess me nts
Scree ni n g
D osi n g
P ost d ose 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  
V 7  
V 8  
V 9
V 1 0/
E D
Wee k(s)
0
1 
2 
3 
4 
6 
8 
1 0 
1 2
St u d y D a y
- 1 4
t o – 2
- 1 
1 
2 
3 
4 
8
± 1 d
1 5
± 2 d
2 2
± 2 d
2 9
± 3 d
4 3
± 3 d
5 7
± 3 d
7 1
± 3 d
8 5
± 3 d
Breat h or uri ne e t ha n ol 
scree n
X
Et ha n ol test is o n t he 
da y of c hec k-i n. If 
scree ni n g visit is t he 
sa me as da y of c hec k-
i n, n o f urt her et ha n ol 
test is re q uire d. Et ha n ol 
scree n ma y be re peate d 
at ot her ti me p oi nts at 
t he discreti o n of t he 
i n vesti gat or.
U ri ne dr u g scree n
X  
X
Da y -1 uri ne test refers 
t o test at c hec k-i n; t his 
is n ot nee de d if c hec k-
i n occ urs o n sa me da y 
as scree ni n g. Dr u g 
scree n ma y be re peate d 
at ot her ti me p oi nts at 
t he discreti o n of t he 
i n vesti gat or.
IV L Y 3 8 3 2 4 7 9 or 
place b o d osi n g
X
Partici pa nts will be 
ra n d o mize d t o recei ve 
eit her L Y 3 8 3 2 4 7 9 or 
place b o. D osi n g ma y be 
dela ye d d ue t o I P bei n g 
u na vaila ble ; see Secti o n 
4. 1 .


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
1 4
Pr oce d ure / 
Assess me nts
Scree ni n g
D osi n g
P ost d ose 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  
V 7  
V 8  
V 9
V 1 0/
E D
Wee k(s)
0
1 
2 
3 
4 
6 
8 
1 0 
1 2
St u d y D a y
- 1 4
t o – 2
- 1 
1 
2 
3 
4 
8
± 1 d
1 5
± 2 d
2 2
± 2 d
2 9
± 3 d
4 3
± 3 d
5 7
± 3 d
7 1
± 3 d
8 5
± 3 d
L Y 3 8 3 2 4 7 9 P K 
sa m pli n ga
Pre d ose ,
e n d of i nf usi o n
( ±1 0 mi ns) ,
6 h o urs ( ±3 0 
mi ns) after st art
of i nf usi o n .
2 4 h
( ± 2 h)
4 8 
( ± 2 h)
X  
X
X  
X  
X
X
Pre d ose c ollecti o n 
s h o ul d be ta ke n wit hi n 
1 5 mi n bef ore d osi n g. 
T he e xact ti me of dra w 
m ust be rec or de d .
I m m u n o ge nicit y sa m plea
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
X
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.
A b bre viati o ns: A E = a d vers e 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; HI V = h u ma n 
i m m u n o deficie nc y vir us; I/E = i ncl usi o n/e xcl usi o n criteria; I V = i ntra ve n o us; 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 ome 
c or o na vir us 2 ; V = Visit
a
W he n c o n d ucte d o n t he sa me da y, t he or der of pr oce d ures s h o ul d be v ital 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 h o 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 ).


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
15
2.
Introduction
Given the current epidemiologic emergency caused by the coronavirus disease 2019 (COVID-19)
pandemic, Eli Lilly and Company (Lilly) is seeking opportunities to identify potential 
prophylactic and treatment options to help in the prevention and control of this public health 
issue. Recently, Lilly entered into a co-development agreement with TopAlliance Biosciences, 
Inc. to develop LY3832479 (also known as JS016-CB6, JS016, or CB6). LY3832479 is a 
recombinant, fully human neutralizing monoclonal immunoglobulin (Ig) G1 kappa antibody with 
abrogated Fc effector function.
2.1.
Study Rationale
Lilly is developing LY3832479 for the treatment and prevention of COVID-19. Study J2Z-MC-
PGAA (PGAA) will investigate the safety, tolerability, and pharmacokinetics (PK) of 
LY3832479 when administered as a single intravenous (IV) dose to healthy participants.
2.2.
Background
The viral pathogen causing the COVID-19 pandemic is the severe acute respiratory syndrome 
coronavirus 2 (SARS-CoV-2). Viral entry into host cells involves its structural Spike 
glycoprotein. The Spike glycoprotein attaches itself via its receptor-binding domain (RBD) to the 
human angiotensin-converting enzyme 2 (ACE2), enabling sufficient proximity for the virus to 
fuse with the target cell membrane. ACE2 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 website [WWW]).
LY3832479 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. Therefore, formation of antidrug 
antibodies (ADAs) and related side effects is unlikely. To further reduce potential toxicity to 
human cells, 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 
antibody-dependent enhancement (ADE).
2.3.
Benefit/Risk Assessment
Concurrent with Study PGAA, LY3832479 is being developed in China in an ongoing Phase 1 
clinical study in healthy participants, Study JS016-001-I. The first cohort of Study JS016-001-I 
was dosed on 07 June 2020, with 3 participants receiving a single infusion of 2.5 mg/kg of 
LY3832479 and 1 participant receiving placebo. As of 23 June 2020, LY3832479 was well 


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
1 6
t olerate d . T he o nl y a d verse e ve nt re p or te d was a mil d a n d tra nsie nt i ncrease i n ser u m creati ni ne 
i n 1 partici pa nt.
T he n o ncli nical safet y p ac ka ge i ncl u des t he f oll owi n g st u dies liste d.

a si n gle-d ose t o xi c o l og y /t o xic o ki netic ( T K) st u d y t hat als o e val uates t he T K of 
L Y 3 8 3 2 4 7 9 i n c y n o m o l g us m o n ke ys. 

A g o o d la b orat or y  practice ( G L P )-c o mplia nt 2 1 -da y re peat -d ose (2 5, 7 5 , 2 05 m g/ k g 
e ver y 3 da ys) st u d y in c y n o m o l g us m on ke ys wit h a 6 -wee k rec o ver y  p erio d. T hi s st u d y 
eval uate d T K a n d safet y p har mac o l og y .

G L P -c o mpl iant  tiss ue cr oss-reacti vity ( T C R) st u dies i n h u ma n a n d c y n o m o l g us tiss ues.
A n i nteri m re p ort i ncl u di n g i n-life data fr o m t he d osi n g p hase f or t he re peat-d ose st u d y  was 
a vaila ble at t he ti me of t he i nitial I B. A n a d dit i onal i nteri m re p ort i ncl u di n g hist o pat h ol o g y , 
res pir at or y fu nct i on a n d T K data is e x pecte d t o be a vaila ble earl y d uri n g t he c o n d uct of t his 
P hase 1 st u d y . A fi nal re p ort f or t he re peat-d ose st u d y is e x pecte d t o be s u b mitte d after t he 
c o mplet i on of t he rec o ver y  p hase. T he I B will be u p date d w he n a d diti on al  inf or mat i on is 
re p orte d.
T he precli nical st u dies bei n g carrie d o ut s u p p ort t he cli nical de vel o p me nt of L Y 3 8 3 2 4 7 9 a gai nst 
a f oreig n tar get . 
Alt h o u g h t here is a n o n g oi n g first -i n-h u ma n cli nical st u d y  testi n g L Y 3 8 3 2 4 7 9 i n health y 
parti ci pa nts i n C hi na ( St u d y J S 0 1 6- 0 0 1-I), o nl y li mite d data fr o m t hat st u d y are a vaila ble at t his 
ti me. T heref ore, S t u d y P G A A has bee n desi g ne d t o be c o n d ucte d i n acc or da nce wit h pri nci pl es 
o utli ne d i n t he G ui deli ne o n Strate gies t o I de ntif y a n d Mit i gate Ris ks for F irst-i n- Hu ma n Cli nical 
Tri als wit h I n vesti gati onal Me dici nal Pr o d ucts ( E M A 2 0 1 7).
A n y i de ntifie d ris ks are c o nsi dere d 
t o be mo ni t ora ble a n d ma na gea ble at t he pla n ne d d ose ra n ge of  7 0 0 t o 7 0 0 0 m g L Y 3 8 3 2 4 7 9 i n 
healt h y parti ci pa nts.
T here i s n o a nticipate d t hera pe uti c be nefit for t he parti ci pa nts.
T he oretical ris ks relate d t o i nf usi o n of L Y 3 8 3 2 4 7 9 are: 

Se vere a c ute i nf usi o n react i on. T his ris k is decrease d d ue t o
o
L Y 3 8 3 2 4 7 9 bei n g di recte d a gai nst a f orei g n tar get
o
t he h u ma n ori gi n o f L Y 3 8 3 2 4 7 9 , a n d 
o
t he re d uce d Fc effect or f u nct i on

Ot her h y perse nsi tivi t y reacti ons as f or a n y  ot her pr otei n pr o d uct

A nt i b o d y-de pe n de nt e n ha nce me nt of  vir al re plicati o n i n case a n y of t hese health y 
v o l un teers 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 Y3 8 3 2 4 7 9
e x p os ure after a si n gle I V i nf usi on . 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 wit h o ut cli nical e vide nce 
i n t he case of res pir at 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 oid t his ri s k as e x plai ne d i n S ectio n 2. 2 . 

U n k n o w n ris ks relate d t o o n -tar get a n d off-tar get t o xicit y. These ris ks are lo w d ue t o t he
o
fact t hat L Y3 8 3 2 4 7 9 tar gets a f orei g n pr otei n, 
o
h u ma n ori gi n o f L Y 3 8 3 2 4 7 9 (t he L A L A m utatio n s d o n ot i n v o l ve t he R B D of  
L Y 3 8 3 2 4 7 9 ), a n d 


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
17
o
absence of binding in the TCR studies performed in humans and monkeys. 
More detailed information about the known and expected benefits and risks and reasonably 
expected adverse events (AEs) of LY3832479 may be found in the IB. 


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
18
3.
Objectives and Endpoints
Objectives
Endpoints
Primary

To investigate the safety and 
tolerability of a single dose of 
LY3832479 in healthy participants

Serious and nonserious adverse 
events, laboratory measures of safety, 
ECG, and vital signs
Secondary

To characterize the pharmacokinetics 
of LY3832479 following a single IV
administration of LY3832479 to 
healthy participants

AUC, Cmax
Abbreviations: AUC = area under the concentration versus time curve; Cmax = maximum observed drug 
concentration; ECG = electrocardiogram; IV = intravenous.


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
19
4.
Study Design
4.1.
Overall Design
Study PGAA is a Phase 1, randomized, placebo-controlled study of LY3832479 administered to 
healthy participants.
Screening
Each participant will provide informed consent for study participation and will undergo a 
screening examination within 14 days prior to enrollment.
Participants may be offered the possibility of staying at the study site between screening and 
dosing. In addition, the day of dosing may be delayed by up to 3 days in the event investigational 
product is unavailable. 
The day of dosing will always be designated as Day 1, the day before dosing will always be 
designated as Day -1, and subsequent activities carried out per the timings in the SoA.
Participants will be discharged on Day 4, and subsequently monitored on an outpatient basis 
until the last follow-up visit.  
In the event of such a delay, the following assessments conducted on Day -1 should be repeated 
on subsequent days until dosing:

COVID-19 clinical screening, 

review/confirm eligibility criteria, 

vital signs, 

body temperature, 

concomitant medications, and 

adverse events.
4.1.1.
Single-Ascending Dose Design
The study will comprise up to 3 cohorts, each with an intended number of participants as 
follows:
Cohorts 1 and 2
At least 9 participants

7 randomized to LY3832479 and

2 randomized to placebo.
Cohort 3
At least 8 participants

6 randomized to LY3832479 and

2 randomized to placebo.
A maximum of 30 participants will be enrolled to study intervention such that approximately 
8 participants have sufficient evaluable data in each cohort.


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
2 0
After at l east 7 partici pa nts ha ve c o m p lete d Da y 4 i n a gi ve n c o h ort (see Sectio n 4. 2 f or 
r atio nale) , all s afet y data u p t o t his c ut off date 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 d ose d, as well as t he d ose t o be use d, aft er a gree me nt bet wee n t he Lill y’s me dical 
m o nit or a n d t he i n vesti gat or. Safet y a n d t olera bilit y data will be t he pri mar y criteria g ui di n g d ose
escalat i on.
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 f or deter mi ni n g a ny d ose decisi o 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 om pre vi o us c o h orts will be re vie we d. 
4. 2.
Scie ntific R ati o n ale f or St u d y Desi g n
T his st u d y  is desi g ne d t o e x pl ore a ra n ge of d oses t hat will i nf or m t he cli nical dr u g de vel o p me nt 
pl a n for L Y 3 8 3 2 4 7 9. 
T he se q ue nt ial c o h ort, si n gle-d ose escalat i on desi g n wit h safet y re vie ws bef ore eac h c o h ort will 
mi ni mize safet y ris ks t o partici pa nts d urin g d ose e x pl orati o n. 
Se nt i nel d osi n g is n ot i ncl u de d i n t his desi g n as L Y 3 8 3 2 4 7 9 is n ot c o nsi dere d a hi g h u ncertai nt y
c o mp o u n d b ase d o n its origi n , str uct ure, me c ha nis m o f act i on / p har ma c olo g y  tar get (it is directe d 
a gai nst a f orei g n tar get) , a n d n o ncli n ical data: 

N o t o xicit y was o bser ve d i n t he si n gle -d ose m o n ke y T K st u d y (st u d y re p ort pe n di n g).

L Y 3 8 3 2 4 7 9 is a m o n ocl o nal  a nti b o d y (m A b ) di recte d a gai nst a f orei g n tar get a n d was 
is olate d fr o m a c o n valesce nt patie nt wi t h C O VI D - 1 9; t heref ore, it has a lo w r is k f or o n-
tar get or off-tar get t o xicit y.

T he ri s k of i nf usi on- r elate d reactio n is c o nsi dere d l o w d ue t o t he tar get, t he re d uce d
effect or f u nct i on ( Fc a n d C o m p le me nt bi n di n g), a n d t he h u ma n ori gi n of t his a nti b o d y.

T he e n gi neere d L A L A m utati o n s are e x pecte d t o re d uce Fc effect or f u nct i on i n 
L Y 3 8 3 2 4 7 9 a n d s h o uld re d uce t he ris k of A D E.
T he 4 -d a y  safety re vie w after d osi n g is s ufficie nt t o detect a n ac ute a d verse i m m u ne res p o nse t o 
treat me nt wit h LY 3 8 3 2 4 7 9 t hat w o uld pre cl u de d ose escalat i on.
4. 3.
J u stificati o n f or D ose
T he d ose le vels f or t his st u d y are desi g ne d t o e x pl ore a wi de e x p os ure ra n ge t hat p ote ntiall y 
e nc o m pass es t he t hera pe utic d ose, a n d will pr o vi de t he safet y a n d t olera bilit y u n der pi n ni n gs f or 
t he cli nical dr u g de vel o p me nt pla n for L Y 3 8 3 2 4 7 9. D ue t o t he u ncertai nt y of  i n vitr o t o i n vi v o
tra nslat i on a n d u ncertai nt y i n tra nslati on of data fr o m a r hes us maca q ue S A R S -C o V -2 i nfecti o n 
m o d el  t o h u ma ns, 3 met h o ds were ut ilize d t o pre dict a n efficaci o us h u ma n d ose ra n ge of 2 0 0 0 t o
7 0 0 0 m g.
T he first met h o d i n v ol ve d i de nt if yi n g a h u ma n d ose t hat w o ul d , i n t he majori t y of patie nts (m o re 
t ha n 9 0 %) , ac hie ve tr o u g h l u n g c o nce ntrati o ns ( Da y 2 8 after d osi n g) greater t ha n t he 
c o nce ntrati o n t hat was f o u n d t o ne utralize 9 0 % of t he vir us (I C 9 0) i n vitr o. T his a p pr oac h use d 
t he h u ma n P K as pr ojecte d fr o m t he m o n ke y T K st u d y a n d i nc or p orate d dr u g distri b uti on i nto 
l u n g tiss ue (S ha h a n d Betts 2 0 1 3 ; Ma g yar ics et al. 2 0 1 9). T his a p pr oac h i de nt ifie d a d ose of 
2 0 0 0 m g.


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
2 1
T he sec o n d me t ho d i n v ol ve d d e velo pi n g a se mi-mec ha nist ic S A R S-C o V -2 vi r al d y na mic m o d el  
(Ki m et al. 2 0 2 0) as a da pte d fr o m a t y pical vi r al d y na mic mo d el  (Ca n gel o si et al. 2 0 1 8). T hi s 
met h o d ai me d t o i de ntif y a d ose t hat w o ul d res ult i n t he m ost ra pi d cleara nce of vir us fr o m a 
patie nt a n d i de nt ifie d a d ose of 3 0 0 0 m g.
T he t hi r d met h o d was t o fi n d a d ose t hat w o ul d ac hie ve h u ma n ser u m c o nce ntratio ns t hr o u g h o ut 
a 2 8-d a y  d osi n g i nter val e q ui vale nt t o ser u m c o nce ntrati o ns i n a s uccessf ul r hes us maca q ue 
S A R S -C o V -2 c halle n ge st u d y . T his met h o d i de ntifie d t hat a d ose of 7 0 0 0 m g ma y  be re q uire d.
T he pr oj ecte d h u ma n half-life of L Y 3 8 3 2 4 7 9, base d o n all o metric scali n g fr o m m on ke y data, is 
e x pecte d t o be i n t he 2 - t o 4-wee k ra n ge .
S af et y mar gi ns f or t he pr o p ose d starti n g a n d ma xi m u m d ose i n t his st u d y are s h o w n i n 
Ta ble 4 . 1.
T he pr o p ose d starti n g h u ma n d ose of  7 0 0 mg has a 1 0-f old m ar gi n of  safety f or e val uati o n of 
safety,  t olera bilit y, a n d P K base d o n e x pecte d e x p os ure ( A U C) r elat i ve t o t he ma xi m u m teste d 
d ose i n a si n gle-d ose m o n ke y t o xi cit y/T K st u d y. T he s u bse q ue nt d oses of 2 8 0 0 a n d 7 0 0 0 m g i n 
t he si n gle-asce n di n g d ose c o h orts are pla n ne d t o be a d mi nistere d f oll owi n g i nteri m safet y data 
fr om t he pre vi o us c o h orts as descri be d i n Sect i on 6. 6 . T he hi g hest pr o p ose d d ose, 7 0 0 0 m g, 
w o ul d ha ve a 1 x mar gi n of safet y. T his mar gi n of safet y is c o nsi dere d acce pta ble f or t he 
f oll owi n g reas o ns:

L Y 3 8 3 2 4 7 9 is a m A b directe d a gai nst a f orei g n tar get a n d was is o late d fr o m a 
c o n valesce nt pati e nt wit h C O VI D - 19 . Theref ore, t he test article d oes n ot bi n d t o 
a nt i ge ns/tar gets e x presse d i n h u ma n tiss ues as c o nfir me d b y a G L P-c o mplai nt T C R st u d y  
i n h u ma n t iss ues, re prese nti n g a l o w ris k f or p ote ntial o n-tar get or off-tar get t o xicit y.

T he 1 x e x p os ure-base d mar gi n f or 7 0 0 0 m g is base d o n t he ma xi m u m d ose teste d i n 
m o n ke ys i n t he si n gle-d ose t o xi c o l og y /T K st u d y. Base d o n cli nical o bser vat i ons a n d 
gr oss e xa mi nat i on at necr o ps y , n o t o xicit y was o bser ve d i n t he a ni mals a d mi nistere d 
1 8 6 m g/ k g of L Y 3 8 3 2 4 7 9 (fi nal re p ort pe n di n g).

T h e ris k of i nf usi on- r elate d reactio n is c o nsi dere d l o w d ue t o t he tar get, t he re d uce d 
effect or f u nct i on ( Fc a n d C om p le me nt bi n di n g), a n d t he h u ma n ori gi n of t his a nti b o d y.

T he e n gi neere d L A L A m utati o n s are e x pecte d t o re d uce Fc effect or f u nct i on i n
L Y 3 8 3 2 4 7 9 a n d s h o uld re d uce t he ris k of A D E (see S ectio n 2. 2 ).


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
22
Table 4.1.
Margin of Safety for Intravenous Administration of LY3832479 Based on 
Administered Dose and Predicted Exposure
Dose
(mg/kg)
Dose
Multiplea
AUC0-∞
(mg*h/mL)a
AUC 
Exposure 
Multiplea
Cmax 
(mg/mL)
Cmax 
Exposure 
Multiplea
Starting human doseb
10
18.6
75
~10
0.253
~19
Highest human doseb
100
1.86
753
~1.0
2.51
~1.9
Cynomolgus monkey
maximum tested dosec
186
750
4.75
Abbreviations: AUC = area under the concentration versus time curve; AUC0-∞= AUC from time zero to infinity; 
Cmax = maximum drug concentration; NOAEL = no-observed-adverse-effect level.
a
Dose multiple is the dose in animals/dose in humans based on milligrams per kilogram. Exposure multiple is the 
calculated AUC and Cmax in animals and predicted AUC and Cmax in humans. 
b
Assume 70-kg bodyweight.
c
Maximum tested dose in the single-dose monkey toxicology/toxicokinetic study.
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 Schedule of Activities
(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
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
2 3
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
Par ticipa 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 n t 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 a n d I V i nf usi o n as descri be d i n 
t his pr ot oc ol  (S o A, Secti o n 1. 3 )
5.
are relia ble a n d willi n g t o ma ke t he msel ves 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.
Male parti ci pa nts m ust a gree t o a d here t o c o ntrace pti o n restrict i 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 me d c o nse nt as descri be d i n A p pe n di x 1 , w hic h
i ncl u des c o m plia nce wit h t he re q uire me nts a n d restricti o ns liste d i n t he i nf or me d c o nse nt 
f or m (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


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
24
11. have had prior SARS-CoV-2 infection, 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 (e.g. 
shaking hands);

having unprotected direct contact with infectious secretions of a person with 
SARS-CoV-2 (e.g. being coughed on, touching used paper tissues with a bare 
hand);

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 (e.g., fever, dry cough, shortness of breath, hypoxia, etc.)
13. have a history or presence of cardiovascular (including hypertension), respiratory, 
hepatic, renal, gastrointestinal, endocrine, hematological, 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 electrocardiogram (ECG) results constituting a risk 
while taking the investigational product, as determined by the investigator
15. have an abnormal blood pressure (BP) as determined by the investigator. In case BP 
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, or 
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 human immunodeficiency virus (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 hepatitis C virus [HCV] RNA)


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
25
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. 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
24. have a significant history of or current psychiatric disorders
Prior/Concomitant Therapy
25. have received treatment with biologic agents (such as mAbs, including marketed drugs) 
within 3 months or 5 half-lives (whichever is longer) prior to dosing
26. have previously completed or withdrawn from this study and have previously received 
the investigational product
27. 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
Prior/Concurrent Clinical Study Experience
28. 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
29. 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
30. are pregnant or breast feeding
31. 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
32. 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 clinical research unit (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)
33. currently smoke in excess of 10 cigarettes per day or are unwilling to abide by CRU 
smoking restrictions
34. regularly use known drugs of abuse and/or show positive findings on drug screening 
unless they were prescribed by a physician (e.g. benzodiazepines).


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
2 6
3 5. are Lill y e m plo y ees or are e mpl o y ees 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 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 c o ntrace pti ve g ui da nce is pr o vi de d i n Secti o n 1 0. 4 , A p pe n di x 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 o ver ni g ht or f or at least 4 h o urs 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 ). Per oral i nta ke s h o ul d be li mite d t o clear li q ui ds f or 4 h o urs 
pri or t o d osi n g . Sta n dar d meals will be a d mi nistere d w hile part ici pa nts are resi de nt at t he st u 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 nt s 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 alc o h o l a n d 
t o bacc o.
5. 3. 3.
Acti vit y
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 plet i 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 re 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 criteria b ut are n ot ra n d o mize d wi t hi n t he 1 4-d a y  scree ni n g 
wi n d o w ma y still e nr oll i n t he st u d y pr o vi de 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 t he nasal or nas o p har y n geal s wa b. T hese s u bjects 
d o n ot nee d t o be d oc u me nte d as scree n fail ure s. S u bjects w h o are eli gi ble b ut are n ot e nr olle d 
wi t hi n 2 8 da ys of t heir i nitial scree ni n g visi t will nee d t o f o ll ow re -scree n pr oce d ures descri be d 
bel o w. 
F or t he p ur p oses of asses si n g eli gi bility,  scree ni n g cli 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 .
I n di vi d uals w h o d o n ot meet t he criteria f or partici pati o n i n t his st u d y (scree n fail ure) d ue t o a 
tra nsie nt mi n or ill ness or c o nc o mita nt me dicat i on ma y be re -scree ne d if a n d w he n t he y  later 
meet eli gi bilit y cri t eria.
Re -scree ne d partici pa nts s h o ul d be assi g ne d a ne w scree ni n g n u m ber. W he n re -scree ni n g, all
scree ni n g tests a n d pr oce d ures s h o ul d be re peate d (e xce pt safet y la b orat or y a nal yses if 
ra n d omizat i on is t o occ ur wit hi n 2 8 da ys of t he first scree ni n g tests). I n di vi d uals ma y be re-
scree ne d o nce, a n d m u st sig n a ne w I C F.


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
27
6.
Study Intervention
Study intervention is defined as any investigational intervention(s) or placebo intended to be 
administered to a study participant according to the study protocol.
6.1.
Study Interventions Administered
Intervention Name
LY3832479
Placebo
Type 
Biologic
Not applicable
Dose Formulation
Solution for infusion
0.9% sodium chloride solution
Unit Dose Strength(s)
400-mg vial
Placebo
Dosage Level(s)

Cohort 1: 700 mg

Cohort 2: 2800 mg

Cohort 3: 7000 mg
Not applicable
Route of 
Administration
IV infusion
IV infusion
Use
Experimental
Placebo
IMP and NIMP
IMP
IMP
Sourcing
Provided by Lilly
Provided by site 
Packaging and 
Labeling
Provided in glass vials and 
labeled appropriately
Per site procedure
Abbreviations: IMP = investigational medicinal product; IV = intravenous; NIMP = noninvestigational medicinal 
product. 
This following table describes the infusion volume and rate for LY3832479. Placebo volume and 
rate will match the LY3832479 dose cohort.
The infusion rate may be reduced as deemed necessary if an infusion reaction is observed. To 
ensure close monitoring, participants will remain in or close to their bed for at least 6 hours after 
completion of the infusion.


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
28
LY3832479
Dose (mg)
Volume withdraw 
from DP vial (mL)
Volume of sterile 
diluent (mL)
Total infusion 
volume (mL)
Start infusion 
rate(duration)
700
17.5
32.5
50
100 mL/h (30 min, 
allowable range 
25 - 60 min)
2800
70
None
70
100 mL/h (42 min, 
allowable range 
37 – 75 min)
7000
175
None
175
100 mL/h (105 min, 
allowable range 
100 - 150 min)
6.1.1.
Infusions
6.1.1.1.
Premedication for Infusions
Premedication for infusions is not planned.
6.1.1.2.
Management of Infusion Reactions
All participants should be monitored closely, during and after infusion as specified in the SoA, as 
there is a risk of infusion reaction and hypersensitivity (including anaphylaxis) with any 
biological agent.
Symptoms and Signs
Symptoms and signs that may occur as part of an infusion reaction include, but are not limited to 
fever, chills, nausea, headache, bronchospasm, hypotension, angioedema, throat irritation, rash 
including urticaria, pruritus, myalgia, and dizziness.
Severity of infusion-related reactions will be assessed and reported using the Division of Allergy 
and Infectious Diseases (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse 
Events, version 2.1 (July 2017). 
This table describes the severity of reactions according to DAIDS.


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
29
Parameter
Mild
Moderate
Severe
Severe and 
Potentially 
Life-threatening
Acute 
Allergic 
Reaction
Localized urticaria 
(wheals) with no 
medical intervention 
indicated
Localized urticaria 
with intervention 
indicated 
OR 
Mild angioedema with 
no intervention 
indicated
Generalized urticaria 
OR
Angioedema with 
intervention indicated 
OR
Symptoms of mild 
bronchospasm
Acute anaphylaxis 
OR 
Life-threatening 
bronchospasm 
OR
Laryngeal edema
Cytokine 
Release 
Syndromea
Mild signs and 
symptoms 
AND
Therapy, that is, 
antibody infusion 
interruption not 
indicated
Therapy indicated 
(that is, antibody 
infusion) interruption 
indicated
AND
Responds promptly to 
symptomatic 
treatment
OR
Prophylactic 
medications indicated 
for ≤24 hours
Prolonged severe 
signs and symptoms 
OR
Recurrence of 
symptoms following 
initial improvement
Life-threatening 
consequences 
(for example, 
requiring pressor or 
ventilator support)
a
A disorder characterized by nausea, headache, tachycardia, hypotension, rash, and/or shortness of breath.
Source: Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 
2.1 (July 2017).
Site Needs
The site must have resuscitation equipment, emergency drugs (including but not limited to 
oxygen, IV fluid, epinephrine, acetaminophen, and antihistamine) and appropriately trained 
personnel available during the infusion and for at least 6 hours after the completion of the 
infusion.
Management of Infusion Reactions
Investigators should determine the severity of the infusion reaction and manage infusion 
reactions based on their clinical judgment and national and international guidance (Lieberman et 
al 2015; Simons et al. 2015). If an infusion reaction occurs, then supportive care should be used 
in accordance with the signs and symptoms.


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
30
6.1.1.3.
Retrospective Positive Sterility Findings 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, BP, 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 interventions 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 
personnel may supply or administer study intervention. All study interventions 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 
personnel.
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 their designee.
Blinding will be maintained throughout the conduct of the study as described in the separate 
Blinding Plan.
Emergency codes will be available to the investigator. A code, which reveals the treatment group 
for a specific study subject, may be opened during the study only if the subject’s well-being 
requires knowledge of the subject’s treatment assignment.
In case of an emergency, the investigator has the sole responsibility for determining if unblinding 
of a subject’s treatment assignment is warranted for medical management of the event. The 
subject’s safety must always be the first consideration in making such a determination. If the 
investigator decides that unblinding is warranted, it is the responsibility of the investigator to 
promptly document the decision and rationale and notify Lilly as soon as possible.


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
3 1
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 w hile t he 
i nf usi on is o n g oi n g, t he partici pa nt m ust be disc o nti n ue d fr om t he st u d y int er ve nt i on a n d t he 
i nf usi on st o p pe d. If a n y am o u nt of st u d y  int er ve nti o 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 vest i 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 eac h d ose a d mi nistere d i n t he cli nic will be rec or de d 
i n t he s o urce d oc u me nts a n d rec or de 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  
parti ci pa nt ide nt ificati on will be c o nfir me d at t he ti me of d osi n g b y a me m ber of t he st u d y  sit e 
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/ o r 
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 electr o nic case 
re p ort f or m (e C R F). Parti ci pa 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 bef ore ta ki n g a n y ne w me di c ati o ns or s u p pl e me nts 
d uri n g t he st u d y .
I n ge neral, c o nc o mita nt me dicati 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 vit a 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 o f 
t he i n vest i gat or f or treat me nt of hea dac he, etc.
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 parti ci pa nt ma y be at t he discreti o n 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 cli nical researc h p h ysicia n ( 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 mp leti o n.
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(s)
ma y be a djust e 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 -Esc al ati o n Criteri a
B y  nat ure of bei n g a P hase 1 s p o ns or u n bli n de d d ose -escalat i on st u d y , data will be e val uate d o n 
a n o n g o i n g basis u ntil t he hi g hest pla n ne d d ose has bee n a d mi nistere d. 
After at l east 7 partici pa nts ha ve c o m p lete d Da y 4 i n a gi ve n c o h ort, all safety data u p t o t his 
c ut off date 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. Safet y a n d t olera bility data will  
be t he pri ma r y crit eri a g uidi n g d ose escalati o n.


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
3 2
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 f or deter mi ni n g a n y d ose decisi ons.
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 pre vi o us c o h orts will be re vie we d.
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 Cr iteri 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, if

3 or m ore parti ci pa nts de vel o p A Es t hat are c o nsi dere d t o be relate d t o st u d y  treat me nt 
a n d gra de d as at le ast mo derate, 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.

1 or m ore parti ci pa nts de vel o p A Es t hat are c o nsi dere d t o be relate d t o st u d y  treat me nt 
a n d t hat are seri o us ( serio us a d verse e ve nts [ S A Es ]) or gra de d as se vere.
T his ta ble desc ribes t he l o 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
D AI D S ta ble descri bi n g se verit y of reacti o ns
Secti o n 6. 1. 1. 2
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 i nstituti o nal  re view b oar d ( I R B)/i n de pe n de nt et hics c o m mittee 
(I E C) bef ore d osi n g c o nti n ues.
6. 7.
I nter ve nti o n after 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
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
3 3
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  dr u g, 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  s pecific sites or of t he trial as a w h ole are 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 derat i ons i n Secti on 1 0. 1 A p pe n di x 1.
7. 1.
Disc o nti n u ati o n of St u d y I nter ve nti o n
I n rare i nsta nces, it ma y be necessar y for a parti ci pa nt t o per ma ne nt l y disc o nti n ue st u d y 
i nter ve nt i on. If t he I V i nf usi on is per ma ne ntl y st o p pe d, t he partici pa nt will re mai n i n t he st u d y 
f or f oll ow- u p a n d f urt her e val uat i ons as de scri be d i n t he S o A.
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 parti ci pa nt ma y wi t hdra 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 desig 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
●
if e nr oll me nt i n a n y ot her cli nical st u d y i n v ol 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 nti 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 ot h fr om t he st u d y i nter ve ntio n a n d fr o m t he st u d y 
at t hat ti me.
If t he parti ci pa nt wi t hdra ws c o nse nt f or discl osur e of  fut ure i nf or m at i on, t he s p o ns or m a 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 di d n ot meet e nr oll me nt criteria a n d 
was i na d verte ntl y e nr olle d, t he n t he partici pa nt s h o ul d be disc o nti n ue d fr o m st u d y  treat me nt a n d 
safety f oll ow- u p s h o ul d be perf or m e d as o utli ne d i n

Secti o n 1. 3 (S o A ), 

Secti o n 8. 2 ( Safety Assess me nts), a n d 


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
3 4

Secti o n 8. 3 ( A d verse E ve nts a n d Seri o us A d verse E ve nts).
7. 3.
L ost t o F oll o w - u p
A partici pa nt will be c o nsi dere d l ost t o f oll o w -u p if  he or s he re peate dl y fails t o ret ur n f or 
sc he d ule d visits a n d is u na ble t o be c o ntacte d b y t he st u d y sit e. Si te pers o n nel are e x pecte d t o 
ma ke dili ge nt atte m pts t o c o ntact partici pa nts w h o fail t o ret ur n f or a sc he d ule d visit or were 
ot her wi se u na ble t o be f oll owe d u p b y t he site.


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
3 5
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 safety c o ncer ns s h o uld be disc usse d wit h t he s p o ns or i m me d iatel 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 i nter 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 nti al part ici pa nts 
meet all eli gi bilit y criteria. T he i n vest i 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 parti ci pa nt s scree ne d a n d t o c o nfir m eli gi bility or rec or d reas o ns f or sc ree 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 o i nts f or all safety assess me nts are pr o vi de d i n t he S o A.
8. 2. 1.
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 dit i 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 ul d 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 c i 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. 2.
Electr oc ar di o gr a ms
Si n gle 1 2 -lea d E C G rea di n gs will be o btai ne d as o utli ne d i n t he S o A (see Secti o n 1. 3 ).
Electr ocar di o gra ms s h o ul d be rec or de d bef ore c ollecti n g a n y bl o o d f or safet y or P K tests.
S u bjects m ust be s u pi ne f or a p pr o xi matel y  5 t o 1 0 mi n utes bef ore E C G c ollecti on a n d re mai n 
s u pi ne b ut a wa ke d uri n g E C G c ollect i on.
Pa per c o pi es of all E C Gs rec or de d s h o ul d be st ore d at t he i n vest i gati onal sit e.
Electr ocar di o gra ms ma y be o btai ne d at a d di tio nal ti mes, w he n dee me d cli nicall y necessar y .
C ollect i on of a d dit i onal E C Gs at a partic ular ti me p oi nt is all o we d t o e ns ure hi g h -q uali t y 
rec or ds. El ectr ocar dio gra ms will  be i nter prete d b y a q ualifie d p h ysicia n (t he i n vesti gat or or 
q ualifie d desi g nee) at t he st u d y  site as s o o n after t he ti me of E C G c ollecti on as p ossi ble, a n d 
i deall y w hile t he s u bject is still prese nt, t o deter mi ne w het her t he s u bject meets e ntr y crit eria at 


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
3 6
t he rele va nt visit(s) a n d f or i m me diate s u bject ma na ge me nt, s h o ul d a n y cli nicall y rele va nt 
fi n di n gs be i de ntifie d.
A n y cli nicall y  sig nifica nt fi n di n gs fr o m E C Gs t hat res ult i n a dia g n osis a n d t hat occ ur after t he 
s u bject recei ves t he i n vesti gati onal pr o d uct s h o ul d be re p orte d t o Lill y, or its desi g nee, as a n A E 
via t he e C R F.
8. 2. 3.  
Cli nic al S afet y L a b or at or y Assess me nts
See Secti o n 1 0. 2 , A p pe n di x 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 (e . g., S A E or A E or d ose m o dificati on), t he n t he res ul ts 
m ust be rec or de d i n t he C R F.
8. 2. 4.
He p atic M o nit ori n g
Cl ose he p atic m o nit ori n g 
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 wi t hi n 4 8 t o 7 2 h o urs t o c o nfir m t he a b n or mality a n d t o deter mi ne if it is 
i ncreasi n g or decreasi n g, if o ne or m ore of t hese c o n diti 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 .


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Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
3 7
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 te sts 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 ur n 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 
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 
o ne 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 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, ultras 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, i ncl u di n g tests f or he patitis D vir us 
( H D V), c yt o me galo vi r us ( C M V), E pstein- Barr vi r us ( 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 on’s disease, bl o o d alc o h o l le vels, 
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 dit i 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  ( M R C P), e n d osc o pic retr o gra de c h ola n gi o pa ncreat o gra p h y (E R C P), 
car diac ec h ocar dio gr a m , or a li ver bi o 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 case re p ort f or ms ( C R F) s h o uld be 
perf or m e d i n st u d y p artici 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: 


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
3 8
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 ore c o nsec uti ve bl o o d tests (if baseli ne A L P 
< 1. 5 x U L N) 

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 seri o us a d verse e ve nt ( S A E) 
5.
Di sc o nti n uatio n of  st u d y dr u g d ue t o a he patic e ve nt .
N ote: t he i nter val bet wee n t he t w o c o nsec uti ve bl o o d tests s h o ul d be at least 2 da y s.
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 nt s 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 io n 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 .
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 d verse E ve nt C R F.
Alt h o u g h all A Es after sig 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 ho ul d 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 S A E data t o t he s p o ns or wit hi n 2 4 h o urs of it bei n g 
availa ble.


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
3 9
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. H o we ver, if t he i n vest i 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 disc 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 
r elate d t o t he st u d y int er ve nt i on or st u d y  partici patio n , t he i n vesti gat or must pr o m pt l 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 uat i 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 .
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 o ll 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 o l 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 oll ow- u p (as de fi 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 .
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 an S A E is esse nt ial 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 safety 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 in vest i gat ors.
A n i n vesti gat or w h o recei ves a n i n vesti 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 (e. g., s u m mar y  or listi n g of S A Es) fr o m 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 ppr o pri ate acc or din g t o l o c al  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 vesti gat 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 b n or m al pre g na nc y o utc o mes (e. g., 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.


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
4 0
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 detail s 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 i nf usi o n- relate d reacti o n/ h y perse nsiti vity C R F.
If s y m pt o ms a n d/ or si g ns occ ur d uri n g or wit hi n 6 h o urs after e n d of i nf usi on of L Y 3 8 3 2 4 7 9 a n d 
are belie ve d t o be h yperse nsi tivi t y or d ue t o c yt o kine release, t he n i n vesti gat ors are e nc o ura ge d 
t o re p ort t he e ve nt as i nf usi on- r elate d i m me diate h y perse nsit i vity react i on or c y t o kine rel ease-
ass ociate d i nf usio n  reactio n, res pect i vel y.
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 on be treate d per nati o nal a n d i nter nat i onal 
g ui da nce ( Lie ber ma n et al 2 0 1 5; Si m o n s 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
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, parti ci pa nts will u n der g o a vi r al t est usi n g 
nasal or nas o p har y n geal s wa b a n d be ma na ge d acc or di n g t o sta n dar d of care. 
S us pi cio n  of S A R S-C o V -2 i nfect i on, i n t he o pi ni o n of t he i n vesti gat or, will rel y u p o n

a rece nt e x p os ure t o S A R S -C o V -2 defi ne d as: 
o
li vi n g i n t he sa me h o use h ol d as a pers o n wit h S A R S-C o V - 2;
o
ha vi n g ha d direct p h ysical c o ntact wit h a pers o n wit h S A R S -C o V -2 (e. g. s ha ki n g 
ha n ds);
o
ha vi n g u n pr otecte d direct c o n tact wit h infect i ous secreti o ns of  a pers o n wit h 
S A R S -C o V- 2 (e. g. bei n g c o u g he d o n, t o uc hi n g use d pa per tiss ues wit h a bare 
ha n d);
o
ha vi n g ha d face -t o-face c o ntact wit h a pers o n wit h S A R S-C o V -2, wit hi n 2 m a n d 
f or more t ha n 1 5 mi n utes.

a n d/ or sig ns or s y m pt o m s t hat, i n t he o pini o n o f t he i n vest i gat or, are s u g gesti ve of S A R S-
C o V -2 i nfect i on (e. g., fe ver, dr y  c o u g h, s h ort ness of breat h, h y p o xia, etc.)
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 m e 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 or nas o p har y n geal 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 hi s 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 h e 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 sh o ul d be discar de d.   
If a n y partici pa nt is teste d p ositi ve p ost baseli ne, pri or t o t his pr ot oc ol a me n d me nt bei n g 
a p pr o ve d, a n a d dit i onal nasal or nas o p har y n geal s wa b sa m ple ma y be c ollecte d f or researc h 
p ur p oses .


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
4 1
8. 3. 8.
I nf usi o n- Rel ate d Re acti o ns
As wi t h ot her m A bs, i nf usi on- relate d reacti o ns ma y occ ur d uri n g or f oll o wi n g L Y 3 8 3 2 4 7 9 
a d mi nistrati o n. If a n i nf usi on- relate d reacti o n occ urs, a d diti onal data descri bi n g eac h s y m pt o m 
a n d si g n s h o ul d be pr o vi de d t o t he s p o ns or i n t he C R F.
T his ta ble descri bes t he l ocati o n of i nf usi o n- r elate d reactio n i nf or m at i on i n t his pr ot oc ol.
T o pic
L oc ati o n
S pecial treat me nt c o nsi derati o ns
Secti o n 6. 1. 1
Ma na ge me nt of i nf usi o n reacti o ns
Secti o n 6. 1. 1. 2
D AI D S ta ble descri bi n g se verit y
Sec ti o n 6. 1. 1. 2
Treat me nt g ui deli nes f or i nf usi o n -relate d reacti o ns 
Secti o n 6. 1. 1. 2
S y m pt o m s occ urri n g d uri n g or after i nf usi o n of st u d y  i nter ve nt i on ma y als o be defi ne d acc or di n g 
t o A E cate g ories s uc h as ac ute aller gic reacti o n or c y t o ki ne release s y n dr o me (r efer t o D AI D S ).
8. 3. 9.
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. 
T he s p o ns or c o llects pr o d uct c o m plai 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 A p pe n di x 1 0. 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 i n 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.


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
4 2
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 s u 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 uld 
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 m ples will be pr o vi de 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  a d mi nistratio n (start a n d e n d of i nf usi o n), a n d

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. 6.
P h ar m ac o d y n a mics
P har mac o d y na mic para meters a re n ot 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 ulati ons 
all o w.
See Secti o n 1 0. 2 Cli nical La b orat or y  T ests, 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
Bl o o d sa m ples will be c ollecte d fr o m all part ici pa nts f or a nal ysis of i m m u ne s yste m a n d 
L Y 3 8 3 2 4 7 9 -r elat e d mar kers. Ser u m sa m ples f or e x p l orat or y bio m ar ker researc h will be 
c ollecte 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 on or a d mi nistrati o n o f L Y 3 8 3 2 4 7 9 i ncl u 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.


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
4 3
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 tar get ( S pr otei n), pat h wa ys ass ociate d wit h disease, a n d/ or 
t he mec ha nis m of act i on of t he st u d y  int er ve nt i on.
P os t-baseli ne s wa b sa m ple s 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
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 
deter 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, P K 
sa m ples will be c o llecte d at t he sa me ti me p oi nts as t he i m m u n o ge nicity sa m ples .
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.


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
4 4
9.
St atistic al C o nsi der a ti o ns
9. 1.
St atistic al H y p ot heses
T his is a n e x pl orat or y  st u d y wit h a pri mar y o bjecti ve of assessi n g safety a n d t olera bilit y. A n y 
h y p ot hesis tests c o n d ucte d f or treat me nt c o m paris o ns will be e x pl orat or y  in nat ure a n d 
c o n d ucte d wit h o ut a dj ust me nt f or m ult i plicity.
9. 2.
S a m ple Size Deter mi n ati o n
A ma xi m u m of 3 0 parti ci pa nts will be e nr o lle d t o st u d y int er ve nt i on s uc h t hat a p pr o xi matel y
8   partici pa nts 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 c ust o mar y  for fi rst-i n-h u ma n st u dies e val uat i n g safety a n d P K, a n d is n ot 
p o were d o n t he basis o f st atistical h y p ot hesis testi n g.
F or re pl ace me nt of partici pa nts w h o are ra n d o mize d b ut n ot d ose d , see Sectio n 4. 1. 1 .
9. 3.
P o p ul ati o ns f or A n al yses
T he f oll owi n g p o p ul at i ons are defi ne d:
P o p ul ati o n
Descri pti o n
E ntere d
All partici pa nts w h o si g n t he I C F
S af et y
All partici pa nts r a n d o ml y assi g ne d t o st u d y  i nter ve nt i on a n d w h o 
are a d mi nistere d at least 1 d ose of st u d y i nter ve nt i o n. 
P arti cipa 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.
P har mac o ki net ic A nal ysis
All ra n d o mize d partici pa nts w h o recei ve d st u d y i nter ve nti on a n d 
ha ve baseli ne a n d ha ve m ult i ple e val ua ble P K sa m ples.
9. 4.
St atistic al A n al yses
Stati stical a nal ysis of t his st u d y will be t he res p o nsi bilit y of sp o ns or or i ts desi g nee.
All tests of treat me nt effects will be c o n d ucte d at a 2 -si de d alp ha le vel of 0. 0 5 , u nless ot her wise 
state d, a n d all c o nfi de nce i nter vals will be gi ve n at a 2-si de d 9 5 %
level .
A n y c ha n ge t o t he data a nal ysis met h o ds descri be d i n t he pr ot oc ol will re q uire a n a me n d me nt 
o nl y  if it c ha n ges a pri ncip al  feat ure of t he pr ot oc ol. A n y ot her c ha n ge t o t he data a nal ysis 
met h o ds descri be d i n t he pr ot oc ol, a n d t he j ust ificati o n f or ma k i n g t he c ha n ge, will be descri be d 
i n t he statistical a nal ysis pla n (S A P ) a n d t he cli nical st u d y re p ort. A d dit i onal e x pl orat or y  
a nal yses o f t he data will be c o n d ucte d as dee me d a p pr o priate.
T he S A P will be fi nalize d pri or t o u n bli n di n g a n d it will i ncl u de a m ore tec h nical a n d detaile d 
descri pt i on of t he statist ical a nal yses descri be d i n t his secti o n. T his secti o n is a s u m mar y of t he 
pl a n ne d statistical a nal yses of t he m ost i m p orta nt e n d p o i nts i ncl u di n g pri mar y a n d ke y sec o n dar y 
e n d p o i nts.


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Protocol number J2Z-MC-PGAA(c)
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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 before dosing.
9.4.2.
Primary Endpoints (Safety)
All analyses of primary endpoints will be made on the Safety Population.
All investigational product- and protocol procedure-related AEs will be listed and, if the 
frequency of events allows, safety data will be summarized using descriptive methodology. The 
incidence of symptoms for each treatment will be presented by severity and by association with 
investigational product as perceived by the investigator.
A TEAE is defined as an event that emerges after treatment (ie, after administration of placebo 
or LY3832479), having been absent pretreatment, or worsens relative to the pretreatment state.
The number of participants who experience a TEAE and/or an SAE (all causalities and related to 
study drug) will be summarized by study treatment. All TEAEs will be summarized by system 
organ class and by decreasing frequency within system organ class.
Other safety parameters that will be assessed include safety laboratory parameters, vital signs, 
and ECG parameters. The parameters will be listed and summarized using summary statistics. 
Additional analysis will be performed if warranted upon review of the data.
9.4.3.
Secondary Endpoints (PK)
Pharmacokinetic parameter estimates for LY3832479 will be calculated using standard 
noncompartmental methods of analysis and summarized by dose using descriptive statistics, if 
sufficient data are available.
The parameters for analysis will be Cmax and AUC of LY3832479. Other noncompartmental 
parameters, such as time to Cmax, apparent terminal elimination half-life, clearance, and volume 
of distribution may be reported. Analyses of other PK parameters may be performed, if 
appropriate.
A compartmental analysis may also be performed to further characterize LY3832479 PK and 
support model-based PK simulations.
9.4.4.
Tertiary/Exploratory Endpoint (Immunogenicity)
The frequency and percentage of participants with preexisting ADA and treatment-emergent 
(TE) ADA+ to LY3832479 will be tabulated. Treatment-emergent ADA+ is defined as those 
with a titer 2-fold (1 dilution) greater than the minimum required dilution if no ADAs were 
detected at baseline (treatment-induced ADA) or those with a 4-fold (2 dilutions) increase in titer 
compared to baseline if ADAs were detected at baseline (treatment-boosted ADA). For the TE 
ADA+ participants, the distribution of maximum titers will be described. The frequency of 
neutralizing antibodies may also be tabulated in ADA+ participants. 


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
4 6
T he rel at i ons hi p bet wee n t he prese nce of a nt i b o dies t o L Y 3 8 3 2 4 7 9 c o nce ntrati o ns/ P K  
para m eters, a n d/ or safet y assess me nt ma y be assesse d.
9. 4. 5.
Ot her A n al yses 
9. 4. 5. 1.
P artici p a nt Dis p ositi o n
A detaile d descri pti o n o f All p arti ci pa nts w h o di sc o nti n ue fr om t he st u d y will be i de ntifie d, a n d 
t he e xte nt of t heir partici pat i on i n t he st u d y will be re p orte d. If k n o w n, a reas o n f or t heir 
di sc o nti n uati on will  be gi ve n.
9. 4. 5. 2.
P artici p a nt C h ar acteristics
Eac h partici pa nt’s baseli ne c haracteristics a n d ot her de m o gra p hic c haracterist ics will be 
rec or de d, liste d, a n d s u m marize d b y tr e at me nt gr o u p a n d o verall.
9. 5.
I nteri m A n al yses 
T here are n o i nt eri m a nal yses pla n ne d f or t his st u d y . If a n u n pla nne d i nteri m a nal ysis is dee me d 
necessar y , t he Lill y C P, C R P/i n vesti gat or, or desi g nee will c o ns ult with t he a p pr o priate me dical 
di rect or or desig nee t o deter mi ne if it is necessar y  t o a me n d t he pr ot oc ol.
F or details o f access t o data d uri n g t he st u d y, see Secti o n 6. 6. 2 .


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Protocol number J2Z-MC-PGAA(c)
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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 International Council for Harmonisation (ICH) good clinical practice (GCP) 
Guidelines, and

Applicable laws and regulations.
The protocol, protocol amendments, ICF, IB, and other relevant documents (e.g., 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 Code of Federal Regulations (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.


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Protocol number J2Z-MC-PGAA(c)
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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 
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 (e.g., 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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Protocol number J2Z-MC-PGAA(c)
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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 (e.g., 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 electronic data capture (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 
copy of pertinent data for retention.


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
5 0
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 in 
t he ce ntral ve n d or’s data base s yste m a n d re p orts wil l 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 sp 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 sp 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 mu st 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-sit e 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 o ns or or i n vesti gat or ma y incl 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 mpl y  wit h 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 vestigat 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 nizati 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 peci fie 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.


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Protocol number J2Z-MC-PGAA(c)
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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
Pharmacokinetic (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
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
5 2
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 be perf or me 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 oll owi n g ta ble f or s pecific la b orat or y t ests.
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 cal re g ulat i 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 ble 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 uat i on, t he res ults m ust be rec or de d in 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 stu d y site s or ot her bli n de d 
pers o n nel.
Pr ot oc ol -s pecific re q uire me nts f or i ncl usi o n or e xcl usi o n of partici pa nts are detaile d i n Sect i on 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 orat or y safet y re p ort.
Refer t o Secti o n 1 0. 6 f or rec o m me n de d la b orat or y t esti n g f or h y perse nsiti vity e ve nts.
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)


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Protocol number J2Z-MC-PGAA(c)
53
Clinical Laboratory Tests
Comments
Aspartate aminotransferase (AST)
Gamma-glutamyl transferase (GGT)
Record on Day 1 and repeat if significantly abnormal value
Blood urea nitrogen (BUN)
Creatinine 
Creatine kinase (CK)
Record on Day 1 and repeat if significantly abnormal value
Uric acid
Record on Day 1 and repeat if significantly abnormal value
Total protein
Albumin
Calcium
Phosphorus
Random glucose
Calculations
Completed locally
eGFR 
Calculated by CKD-EPI equation
Hepatitis B surface antigen
Hepatitis B core antibody (HBcAb) 
Hepatitis C antibody
HIV
SARS-Cov-2 viral infection determination
Local laboratory
  SARS-Cov-2 nasopharyngeal test
At screening visit. To be performed only if SARS-CoV-2 point of 
care test is not available
 SARS-Cov-2 point of care
On Day -1 if available, and during the study at the investigator’s 
discretion
SARS-Cov-2 nasal or nasopharyngeal sample 
for research purposes
Sent to the sponsor for analysis if the SARS-Cov-2 point of care test
performed in parallel is positive
SARS-Cov-2 serology
At screening, and then according to schedule of activities
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.


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Protocol number J2Z-MC-PGAA(c)
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Clinical Laboratory Tests
Comments
Pharmacogenetic sample
Assayed by Lilly-designated laboratory. 
Results will not be provided to the study sites.
Exploratory Biomarker Samples
Assayed by Lilly-designated laboratory. 
Results will not be provided to the study sites.
Serum
Immunogenicity Samples
Assayed by Lilly-designated laboratory. 
Results will not be provided to the study sites.
Anti-LY3832479 antibodies 
Anti-LY3832479 antibodies neutralization
Abbreviations: CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; eGFR = estimated glomerular 
filtration rate; HIV = human immunodeficiency virus; SARS-Cov-2 = severe acute respiratory syndrome 
coronavirus 2.


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Protocol number J2Z-MC-PGAA(c)
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10.2.1.
Blood Sampling Summary
This table summarizes the approximate number of venipunctures and volumes for all blood 
sampling during the study.
Protocol J2Z-MC-PGAA Sampling Summary
Purpose
Blood Volume per 
Sample (mL)
Number of Blood 
Samples
Total Volume 
(mL)
Screening testsa
45
1
45
Clinical laboratory testsa
15
9
135
SARS-CoV-2 serology
10
5
50
Pharmacokinetics (including up to 
5 extra samples if needed)
4
11 (16)
44 (64)
Blood discard for cannula patency
1
8
8
Immunogenicity
10
5
50
Pharmacogenetics
3
1
3
Serum for exploratory biomarkers
10
6
60
Total
395 (415)
Total for clinical purposes (rounded up to the nearest 10 mL)
400 (420)
a
Additional samples may be drawn if needed for safety purposes.


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
5 6
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 w ar d me d ical occ urre nce i n a patie nt or cli nical st u d y partici pa nt, 
t e mp orall y  ass o ciat e d wit 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 
r elate d t o t he st u d y int er 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 (incl u di n g a n 
a b n or mal la b orat or y fi n di n g), s y m pt o m, or disease ( ne w or e xacer bate d) te m p orall y 
ass ociat e 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 uri nal ysis) or 
ot her safet y assess me nts (e . g., E C G, ra di ol ogical sca ns, vital si g n meas ure me nts), 
i ncl u di n g t h ose t hat w orse n fr om baseli ne, c o nsi dere d cli nicall y si g nifica nt i n t he 
me dical a n d scie nt ific j u d g me nt of t he i n vesti 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 -e xist 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 dicati 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 nte nti o nal o ver d ose ta ke n wit h p ossi ble s uici dal/self -har mi n g 
i nte nt. S uc h o ver d 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 D efi niti o n

A n y cli nicall y  sig nifica nt a b n or mal la b orat or y  fi n di n gs or ot her a b n or mal safety 
assess me nts t hat are ass ociate d wit h t he u n derl yi n g disease, u nless j u d ge d b y t he 
i n vesti gat or t o be m ore se vere t ha n e x pecte d f or t he partici pa nt’s c o n diti on.

T he disease/ dis or der bei n g st u di e d or e x pecte d pr o gressi o n, si g 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 (e . g., e n d osc o p y, a p pe n dect o m y): t he c o n diti 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).


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
5 7

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 sta rt 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
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 e ve n if seri o us c o n dit i ons 
are met (e. g., h os pitalizati on f or sig ns/s y m pt o ms of t he disease u n der st u d y , deat h d ue t o 
pr o gressi o n of disease).
A n S A E is defi ne d as a n y u nt o w ar d me dic al occ urre nce t h at, at a n y d ose:
a.
Res ults i n de at h
b.
Is life-t hre ate ni n g
T he ter m  “life-t hreate ni n g” i n t he defi niti on of “s erio 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 aliz 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 o bser vati on a n d/ or treat me nt t hat w o ul d n ot ha ve bee n a p pr o priate i n t he 
p h ysicia n’s office or o ut patie nt setti n g. C o m plicat i o ns t hat occ ur d uri 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 talizatio n or f ulfills a n y  ot her serio us cri t eria, 
t he e ve nt is seri o us. W he n i n d o u bt as t o w het her “ h os pitalizati o n” occ urre d or was 
necessar y , t he A E s h o uld be c o nsi dere d seri o us.

H os pitalizati o n 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 nc tio ns.

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, 
a n d acci de ntal tra u ma (e . g., s prai ne d a n kle) t hat ma y i nterfere wit h or pre ve nt 
e ver y da y life f u ncti o ns b ut d o n ot c o nstit ute a s u bsta ntial disr u pt i on.
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 uati o 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 1 of  t he ot her 


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
5 8
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.

E xa m ples of s uc h e ve nts i ncl u de i n vasi ve or mali g na nt ca ncers, i nte nsi ve treat me nt i n 
a n e mer ge nc y r o o m or at h o me f or aller gic br o nc h os pas m, bl o o d d yscrasias , or 
c o n v ulsi o ns t hat d o n ot res ult i n h os pit alizat i on, 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 (e . g., h os pital pr o gress n otes, la borat 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 t he sp o ns or or desi g nee i n lie u of c o m pleti o n 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 t h e sp o ns or or desi g nee . I n t his case, all partici pa nt i de ntifiers, wit h t he e xce pti on of 
t he partici pa nt n u m ber, will be re dacte d o n t he c o pies of t he me dical rec or ds bef ore 
s u b missi on t o t he sp 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 mati on. W he ne ver p ossi ble, t he di a g n osis ( n ot t he 
i n di vi d ual si g ns/s y m pt o ms) will be d oc u me nte d as t he A E/ S A E.
Assess me nt of I nte nsit 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 1 of t he f oll owi n g cate g ori es:

Mil d: A n e ve nt t hat is easil y t olerate d b y t he partici pa nt, ca usi n g mi ni mal disc o mf o rt,
a n d n ot i nterferi n g wit h e ver y da y act i vities.

M o derate: A n e ve nt t hat ca uses s ufficie nt disc o mf ort a n d i nterferes wit h n or m al 
e ver y da y act i vities.

Se vere: A n e ve nt t hat pre ve nts n or mal e ver yda y acti vi ties. A n A E t hat is assesse d as 
se vere s h o ul d n ot be c o nf use d wit h an S A E. Se vere is a cate g or y  utilize d f or rati n g t he 
i nte nsit y of a n e ve nt; a n d b ot h A Es a n d S A Es ca n be assesse d as se vere.
A n e ve nt is defi ne d as ‘seri o us’ w he n i t 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.


C O N FI D E N TI A L
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
5 9

T he i n vest i gat or will c o nsi der a n y A Es, S A Es, a n d cli nicall y i m p orta nt la b orat or y 
a b n or malities as relate d t o t he st u d y int er ve nt i on u nless t here is clear e vi de nce t hat t he 
e ve nt is n ot relate d.

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 u n derl yi n g disease(s), c o nc o mita nt t hera p y, a n d ot her ris k 
fact ors, as well as t he te m p oral relati o ns hi p of t he e ve nt t o st u d y int er ve nt i on 
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 t he sp o ns or or desi g nee . 
H o we ver, it is ver y  im p orta nt t hat t he i n vest i gat or al wa ys ma ke a n assess me nt of 
ca usalit y f or e ver y e ve nt bef ore t he i nit ial tra ns missi o n of t he S A E data t o t he sp o ns or 
or desi g nee .

T he i n vest i gat or ma y c ha n ge his/ her o pi ni on of ca usalit y i n li g ht of f oll ow- u p 
i nf or mat i on a n d se n d a n S A E f oll o w -u p re p ort wi t h t he u p date d ca usality asse ss me nt.

T he ca usalit y assess me nt is 1 of  t he criteria use d w he n deter mi ni n g re g ulat or y 
re p orti n g re q uire me nts.
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 t he sp 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 oss i ble. T his ma y i ncl u de a d diti onal la b orat or y  tests or i n vesti gati ons, 
hist o pat h ol o gical e xa mi nat i ons, or c o ns ultati o n wit h ot her healt h care pr ofessi o nals.

If a partici pa nt dies d uri n g partici pati o n i n t he st u d y or d uri n g a rec o g niz e d fol l ow- u p 
p eri o d, t he i n vest i gat or will pr o vi de t he sp o ns or or desi g nee wi t h a c o p y of a n y 
p ost m ort e m  fi n din 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 p lete d C R F.

T he i n ve sti gat or will s u b mit a n y u p date d S A E data t o t he sp o ns or or desi g nee wi t hi n 
2 4 h o urs of recei pt of t he i nf or mati o n.
1 0. 3. 4.
Re p orti n g of S A Es
S A E Re p orti n g vi a P a per C R F

Facsi mile tra ns missi o n of t he S A E Re p ort 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 or desi g nee.

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 mplete a n d si g n t he S A E Re p ort wit hi n t he desi g nate d re p orti n g ti me fra mes.


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
60

Contacts for SAE reporting can be found in the SAE Report.


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
61
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 (e.g., 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, 
(e.g., 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 (FSH)

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 (e.g. 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.


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
62
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
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
6 3
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
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
6 4
1 0. 5.
A p pe n di x 5 : Ge netics
S a m ple c ollect i 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 ( Cli nical La b orat or y Tests).
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, m eta b o lis m, a n d e xcreti o 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 or e ca n di date 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 st u 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 iality.
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
Pr ot oc ol  n u m ber J 2 Z-M C -P G A A (c)
6 5
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. 4 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 bl o 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 time, 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 y b
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


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
66
    HCV RNA c
    EBV DNA c
Hepatitis D virus (HDV) testing:
Cytomegalovirus (CMV) testing:
    HDV antibody
    CMV antibody
Hepatitis E virus (HEV) testing:
    CMV DNA c
    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) DNA c
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.


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
67
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.


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
68
Clinical Laboratory Tests for Hypersensitivity Events
Hypersensitivity Tests
Notes
Selected test may be obtained in the event of anaphylaxis or 
systemic allergic/hypersensitivity reactions.
LY3832479 antidrug 
antibodies 
(immunogenicity/ADAs)
Assayed by Lilly-designated laboratory. 
Results will not be provided to the study sites.
LY3832479 concentrations 
(PK)
Assayed by Lilly-designated laboratory. 
Results will not be provided to the study sites.
Tryptase
Assayed by Lilly-designated laboratory. 
Results will not be provided to the study sites.
The study site should attempt to obtain a tryptase sample within 2 
hours of the event. If more than 12 hours have passed since the 
event, no tryptase sample should be obtained. If the tryptase sample 
is obtained between 2 and 12 hours, or is not obtained, the site 
should collect a urine sample for N-methylhistamine testing. 
Collect the first void urine following the event. Collect a follow-up 
urine sample after approximately 4 weeks.
N-methylhistamine
Assayed by Lilly-designated laboratory. 
Results will not be provided to the study 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 study 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 study 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 study sites.
Cytokine panel
Assayed by Lilly-designated laboratory. 
Results will not be provided to the study sites.
Abbreviations: IgE = immunoglobulin E; PK = pharmacokinetics.


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
69
10.8.
Appendix 8: Abbreviations
Term
Definition
ACE2
angiotensin-converting enzyme 2
ADA
antidrug antibody
ADE
antibody-dependent enhancement
AE
adverse event
ALP
alkaline phosphatase
ALT
alanine aminotransferase
AST
aspartate aminotransferase
blinding
A double-blind study is 1 in which neither the participant nor any of the investigator or 
sponsor personnel who are involved in the treatment or clinical evaluation of the 
participants are aware of the treatment received.
BMI
body mass index
BP
blood pressure
CFR
Code of Federal Regulations
CK
creatine kinase
CMV
cytomegalovirus
CT
computed tomography
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
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


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
70
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.
ERCP
endoscopic retrograde cholangiopancreatography
FSH
follicle-stimulating hormone
GCP
good clinical practice
GGT
gamma-glutamyltransferase
GLP
good laboratory practice
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
Ig
immunoglobulin
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.
intervention
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.
INR
international normalized ratio
IRB
institutional review board
IV
intravenous
mAb
monoclonal antibody


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
71
MRCP
magnetic resonance cholangiopancreatography
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
PK/PD
pharmacokinetics/pharmacodynamics
PT
prothrombin time
RBD
receptor-binding domain
SAE
serious adverse event
SAP
statistical analysis plan
SARS-CoV-2
severe acute respiratory syndrome coronavirus 2
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. 
SoA
Schedule of Activities
TBL
total bilirubin
TCR
tissue cross-reactivity
TE
treatment emergent
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.
TK
toxicokinetic(s)
ULN
upper limit of normal


CONFIDENTIAL
Protocol number J2Z-MC-PGAA(c)
72
11.
References
Cangelosi RA, Schwartz EJ, Wollkind DJ. A quasi-steady-state approximation to the basic 
target-cell-limited viral dynamics model with a non-cytopathic effect. Front Microbiol. 
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Division of AIDS (DAIDS) table for grading the severity of adult and pediatric adverse events. 
National Institute of Allergy and Infectious Diseases. National Institutes of Health. US 
Department of Health and Human Services. Corrected version 2.1. July 2017. Available at: 
https://rsc.niaid.nih.gov/sites/default/files/daidsgradingcorrectedv21.pdf. Accessed May 19,
2020.
[EMA] European Medicines Agency. Guideline on strategies to identify and mitigate risks for 
first-in-human and early clinical trials with investigational medicinal products. 2017. 
Available at: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-
strategies-identify-mitigate-risks-first-human-early-clinical-trials-investigational_en.pdf. 
Accessed May 19, 2020.
Graham BS. Rapid COVID-19 vaccine development [published online May 08, 2020]. Science. 
doi: 10.1126/science.abb8923.
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;203:631-637.
Human Protein Atlas Project website. Available at:
https://www.proteinatlas.org/ENSG00000130234-ACE2/tissue. Accessed May 14, 2020.
Kim KS, Ejima K, Ito Y, et al. Modelling SARS-CoV-2 dynamics: implications for therapy. 
2020. medRxiv doi: https://doi.org/10.1101/2020.03.23.20040493.
Lieberman P, Nicklas RA, Randolph C, et al. Anaphylaxis – a practice parameter update 2015. 
Ann Allergy Asthma Immunol. 2015; 115:341-384.
Magyarics Z, Leslie F, Bartko J, et al. Randomized, double-blind, placebo-controlled, 
singleascending-dose study of the penetration of a monoclonal antibody combination 
(ASN100) targeting Staphylococcus aureus cytotoxins in the lung epithelial lining fluid of 
healthy volunteers. Antimicrob Agents Chemoter. 2019;63(8). pii:e00350-19.
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;8:32.
Shah Dk, Betts AM. Antibody biodistribution coefficients: inferring tissue concentrations of 
monoclonal antibodies based on the plasma concentrations in several preclinical species and 
human. MAbs. 2013;5(2):297-305.


L e o  D o c u m e n t  I D  =  c 7 3 8 d 4 7 d - 0 3 9 7 - 4 0 8 7 - 9 5 8 0 - 0 7 c e 6 b d 5 e 3 4 9
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 - J u l - 2 0 2 0  1 3 : 0 3 : 4 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
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 - J u l - 2 0 2 0  1 3 : 1 1 : 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 2): J 2 Z- M C- P G A A
A P hase 1, Ra n d o mize d, Place b o- C o ntr olle d St u d y t o E val uate t he T olera bilit y, Safet y, 
P har mac o ki netics, a n d I m m u n o ge nicit y of L Y 3 8 3 2 4 7 9 Gi ve n as a Si n gle I ntra ve n o us D ose i n 
Healt h y Partici pa nts
N C T 0 4 4 4 1 9 3 1   
A p pr o val Date: 2 4-J ul- 2 0 2 0


F i nal v 2, 2 3 J ul 2 0 2 0
             Pa ge 1 of 1 5
S T A TI S TI C A L A N A L Y SI S P L A N
A P h ase 1, R a n d o mize d, Pl ace b o -C o ntr olle d St u d y t o E v al u ate t he T oler a bilit y, S afet y, 
P h ar m ac o ki netics, a n d I m m u n o ge nicit y of L Y 3 8 3 2 4 7 9 Gi ve n as a Si n gle I ntr a ve n o us D ose 
i n He alt h y P artici p a nts
Stati stical A nal ysis Pla n Stat us : Fi nal v 2
Stati stical A nal ysis Pla n Date : 2 3 -J ul-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 A
C o va nce C R U St u d y : 1 0 0 0 0 7 1 -8 4 4 3 0 9 3
Cli nical P hase I
A p pr o v al D at e: 2 4- J ul- 2 0 2 0 G M T


F i nal v 2, 2 3 J ul 2 0 2 0
             Pa ge 2 of 1 5
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 4 3 0 9 3
S p o ns or Refere nce J 2 Z -M C -P G A A
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 ..............................................................................................................3
3.
I N T R O D U C TI O N ...............................................................................................................5
4.
S T U D Y O BJ E C TI V E S ........................................................................................................5
4. 1
Pri mar y O bject i ve..........................................................................................................5
4. 2
Sec o n dar y  O bjecti ve......................................................................................................5
5.
S T U D Y D E SI G N .................................................................................................................6
6.
T R E A T M E N T S ...................................................................................................................6
7.
S A M P L E SI Z E J U S TI FI C A TI O N .......................................................................................7
8.
D E F I NI TI O N O F A N A L Y SI S P O P U L A TI O N S ..................................................................7
9.
S T A TI S TI C A L M E T H O D O L O G Y .....................................................................................7
9. 1
Ge neral ..........................................................................................................................7
9. 2
D e m o gra p hics a n d S u bject Dis p osit i on ..........................................................................8
9. 3
P har mac o ki net ic Assess me nt .........................................................................................8
9. 3. 1
P har mac o ki net ic a nal ysis......................................................................................8
9. 3. 2
P har mac o ki net ic statistical met h o d ol o g y ............................................................1 2
9. 4
S af et y a n d T olera bilit y Assess me nts ............................................................................1 2
9. 4. 1
A d verse e ve nts ...................................................................................................1 2
9. 4. 2
C o nc o mita nt me dicat i on .....................................................................................1 3
9. 4. 3
Cli nical la b orat or y  para meters............................................................................1 3
9. 4. 4
Vi t al si g ns ..........................................................................................................1 3
9. 4. 5
Electr ocar di o gra m ..............................................................................................1 3
9. 4. 6
He pati c M o nit orin g ............................................................................................1 3
9. 4. 7
H y perse nsi tivi t y reacti ons ...................................................................................1 4
9. 4. 8
I nf usi on- site reactio ns......................................................................................... 1 4
9. 4. 9
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 4
9. 4. 1 0
Ot her assess me nts ...............................................................................................1 4
9. 4. 1 1
S afet y a n d T olera bilit y Statisti c al Met h o d olo g y.................................................. 1 4
1 0. I N T E RI M A N A L Y S E S .....................................................................................................1 4
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 4
1 2. R E F E R E N C E S ..................................................................................................................1 4
1 3. D A T A P R E S E N T A TI O N ..................................................................................................1 5
1 3. 1 Deri ve d Para meters .....................................................................................................1 5
1 3. 2 Missi n g Data ...............................................................................................................1 5
1 3. 3 I ns ufficie nt Data f or Prese ntati o n ................................................................................1 5
1 4. V E R SI O N HI S T O R Y ........................................................................................................1 5


F i nal v 2, 2 3 J ul 2 0 2 0
             Pa ge 3 of 1 5
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 4 3 0 9 3
S p o ns or Refere nce J 2 Z -M C -P G A A
2. A B B R E VI A TI O N S
A b bre viat i ons pertai n t o t he Statistical 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 E
A d verse e ve nt
A L P
A l kali ne p h os p hatase
A L T
A la ni ne a mi n otra nsferase
A S T
A s partate 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 t i me 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
% A U C(t
last-)
Perce nta ge of A U C( 0 -∞) e xtra p olate d
B Q L
B elo w t he l o wer li mit of q ua nt ificat i on
C L
T ot al  b o d y cleara nce of dr u g calc ulate d 
C ma x
Ma xi m u m o bser ve d dr u g c o nce ntrati 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
D AI D S
Di visi o n of Aller g y  a n d I nfecti ous Diseases
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 nisati o n
I V
Int ra ve n o us
Me d D R A
Me dical Dict i onar y f or Re g ulat or y  Acti vities
M R E
M a g net ic res o na nce elast o gra p h y
P K
P har mac o ki net ic
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
S D
Sta n dar d de viat i on 
T F Ls
Ta bles, Fi g ures, a n d List i n gs


F i nal v 2, 2 3 J ul 2 0 2 0
             Pa ge 4 of 1 5
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 4 3 0 9 3
S p o ns or Refere nce J 2 Z -M C -P G A A
t½
Half -life ass ociat e 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 otal  bilir u bi n
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 ss
V ol u me of distri b ut i on at stea d y  state 
V z
V ol u me of distri b ut i on d uri n g t he ter mi nal p hase
W H O
W o rld Heal t h Or ga nizati on


F i nal v 2, 2 3 J ul 2 0 2 0
             Pa ge 5 of 1 5
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 4 3 0 9 3
S p o ns or Refere nce J 2 Z -M C -P G A A
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 0 3
J u ne 2 0 2 0 ) a n d Pr ot oc ol A me n d me nt (c) (fi nal versi o n date d 1 5 J ul y 2 0 2 0) .
T his S A P descri bes t he pl a 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 nical 
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 vide g ui da nce f or t he stati stical 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 i nter pretati o 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 m pa 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 o i n vesti gate t he safet y a n d t olera bilit y of a si n gle d ose of L Y 3 8 3 2 4 7 9 i n health y part ici pa nts.
T he pri mar y  e n d p oi nts are serio us a n d n o n -serio us a d verse e ve nts ( A E), la b orat or y meas ures of 
safety,  electr ocar di o gra m ( E C G ), a n d vital si g ns.
4. 2
Sec o n d ar y O bjecti ve
T o c haracterize t he P K of  L Y3 8 3 2 4 7 9 f oll owi n g a si n gle int ra ve n o us (I V) a d mi nistrati o n of 
L Y 3 8 3 2 4 7 9 t o healt h y part ici pa nts.
T he sec o n dar y  e nd p oi nts are a rea u n der t he c o nce ntrati o n vers us ti me c ur ve ( A U C) a n d 
ma xi m u m o bser ve d dr u g c o nce ntrati o n (C ma x ).


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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 4 3 0 9 3
S p o ns or Refere nce J 2 Z -M C -P G A A
5. S T U D Y D E SI G N
St u d y  P G A A is a P hase 1, ra n d o mize d, place b o-c o ntr olle d st u d y of LY 3 8 3 2 4 7 9 a d mi nistere d t o 
healt h y partici pa nts. A st u d y  sc he ma f or P G A A ca n be see n i n Fi g ure 1 .
T he st u d y  will c o mprise u p t o 3 c o h orts:
C o h orts 1 a n d 2 (at least 9 partici pa nts):

7 ra n d o mize d t o L Y 3 8 3 2 4 7 9 a n d

2 ra n d o mize d t o place b o.
C o h ort 3 (at least 8 partici pa nts):

6 ra n d o mize d t o L Y 3 8 3 2 4 7 9 a n d

2 ra n d o mize d t o place b o.
A ma xi m u m of 3 0 partici pa nts will be e nr o lle d t o st u d y i nter ve nti on s uc h t hat a p pr o xi matel y 
8   partici pa nts ha ve s ufficie nt e val ua ble data i n eac h c o h ort.
After at l east 7 partici pa nts ha ve c o m p lete d Da y 4 i n a gi ve n c o h ort, all safety data u p t o t his 
c utoff date 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 d ose d, as well as t he 
d ose t o be use d, aft er a gree me nt bet wee n t he Lill y’s me dical m o n itor a n d t he i n vest i gat or. Safet y 
a n d t olera bilit y data will be t he pri mar y criteria g ui di n g d ose -escalati o n.
A b br e vi ati o ns:  L Y = L Y 3 8 3 2 4 7 9; P B O = pl a c e b o.  
Fi g ur e 1 : A ge n er al s c h e m a f or st u d y J 2 Z -M C -P G A A
6. T R E A T M E N T S
T he f oll 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 o ole d p lace b o I V
1
1
7 0 0 m g L Y 3 8 3 2 4 7 9 I V
2
2
2 8 0 0 m g L Y 3 8 3 2 4 7 9 I V
3
3
7 0 0 0 m g L Y 3 8 3 2 4 7 9 I V
4


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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 4 3 0 9 3
S p o ns or Refere nce J 2 Z -M C -P G A A
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 3 0 parti ci pa nts will be e nr o lle d t o st u d y int er ve nt i on s uc h t hat 
a p pr o xi matel y 8   partici pa nts ha ve s ufficie nt e val ua ble data i n eac h c o h ort .
T he sa m ple size n ot p o were d o n t he basis o f st atistical h y p ot hesis testi n g. H o we ver, t he n u m ber 
of  s u bjects is c om m o n i n earl y cli nical p har mac o l og y  st u dies a n d is c o nsi dere d s ufficie nt t o 
ac hie ve t he o bject i ves of t he trial.
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 n tere d” p o p ulatio n will  c o nsist of a ll partici pa nts w h o si g n t he i nf or me d c onse nt f or m 
(I C F).
T he “ Safet y” p o p ulat i on will c o nsist o f a ll partici pa nts ra n d oml y assi g ne d t o st u d y int er ve nt i on 
(L Y 3 8 3 2 4 7 9 or place b o) a n d w h o are a d mi nistere d at least 1 d ose of st u d y int er ve ntio n.
T he “ P har mac o ki net ic” p o p ulat i on will c o nsist of a ll ra n d omize d part ici pa nts w h o recei ve d 
st u d y int er ve ntio n ( L Y 3 8 3 2 4 7 9), ha ve baseli ne , a n d ha ve mul tiple e val ua ble P K sa m ples.
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 der at i on w he n s u bjects 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 are 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), m e dia n, 
mi n i m u m, ma xi m u m, a n d N; f or l o g -n or m al data (e. g. t he P K para meters: A U Cs a n d C ma x) t he 
ge o m etric mea n a n d ge o metric c oefficie nt of va riatio n ( C V %) will als o be prese nte d . F o r 
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 s u bjects u p t o t he p oi nt of wit h dra wal, wit h a n y  s u bjects e xcl u de d fr o m t he 
r ele va nt p o p ulati o n hi g hli g hte d . S u m mar y statist ics a n d statistical a nal yses will ge nerall y o nl y be 
perf or m e d for s u bjects i ncl u de d i n t he rele va nt a nal ysis p o p ulat i on . 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 g e f r o m baseli ne is t he mea n of all i n di vi d ual s u bjects’ 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 btracti n g t he i n di vi d ual s u bject’s 
baseli ne val ue fr o m t he val ue at t he ti me p o i nt. T he i n di vi d ual s u bject’s c ha n ge fr o m 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.
Data a nal ysis will be perf or me d usi n g S A S ® Versi o n 9. 4 or greater.


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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 4 3 0 9 3
S p o ns or Refere nce J 2 Z -M C -P G A A
9. 2
De m o gr a p hics a n d S u bject Dis p ositi o n
S u bject dis p osit i on wi ll 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,  bo 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 n t
Ve n o us bl o o d sa m ples wi ll be c ollecte d as s pecifie d i n t he pr ot oc ol’s sc he d ule of assess me nts f or 
deter mi nat i on of c o nce ntrati o ns of ser u m L Y 3 8 3 2 4 7 9 use d t o e val uate t he P K of L Y 3 8 3 2 4 7 9.
9. 3. 1
P h ar m ac o ki netic a n al ysis
A n y P K a nal yses pri or t o data base l oc k will be t he res p o nsi bilit y of  Eli Lill y P K/ P D gr o u p, 
w hereas a n y P K a nal yses p ost data base l oc k will be re p orte d b y  C o va nce.  
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 
Versi o n 8. 1 or l ater) 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 owi n g P K para meters, w he n p ossi ble: 
P ar a meter
U n itsa
Defi niti o n
A U C( 0 -tlast)
µ g. h/ m L
Ar 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
A U C( 0 -∞)
µ g. h/ m L
Ar 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-)
%
Perce nta ge of A U C( 0 -∞) e xtra p olate d
C ma x
µ g/ m L
Ma xi m u m o bser ve d dr u g c o nce ntrati o n
tlast
h
Ti me of t he last o bser ve d dr u g c o nce ntrati o n
tma x
h
Ti me of ma xi m u m o bser ve d dr u g c o nce ntrati o n
t½
h
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
C L
L/ h
T otal b o d y cleara nce of dr u g calc ulate d 
V z
L
V ol u me of distri b uti o n d uri n g t he ter mi nal p hase
V ss
L
V ol u me of distri b uti o n at stea d y state 
a S e r u m LY 3 8 3 2 4 7 9 dr u g c o nce ntrati o n u nits will c o me i n fr o m t he bi oa nal ytical la b as n g/ m L t o o ne 
deci ma l place; t he data will be tra nsf or me d t o µ g/ m L f or a nal ysis.
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 C S R . A n y 
e xce pti o ns 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 viati 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.


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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 4 3 0 9 3
S p o ns or Refere nce J 2 Z -M C -P G A A
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 ti me of ma xi m u m o bser ve d dr u g c o nce ntrati o n (tma x ) will be re p orte d fr o m 
o bser ve d val ues. If Cma x occ urs at m ore t ha n o ne time p oi nt, t ma x will be assi g ne d t o t he 
first occ urre nce of Cma x. 

A U C para m eters 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 mic 
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 ho 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 tma 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 ntratio ns a b o ve t he l ower li mi t of q ua ntificat i on , wit h at least 
o ne of t hese c o nce ntrati o ns f o ll owi n g C ma x.

A U C( 0 -) values w here t he perce nta ge of  t he t otal area e xtra p olat e d is m o re t ha n 2 0 % 
will be fla g ge d . A n y A U C( 0 -) val ue e xcl u de d fr o m s u m mar y statistics 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 o g-
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 s u bject will be defi ne d b y vis ual i ns pecti 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 yste mat ic de viati on fr o m t he l o 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 est i 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 t½ 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 listi n gs. A n y 
t½ val ue e xcl u de d fr o m s u m mar y st atistics will be d oc u m e 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 gressi o n a nal ysis of t he ter mi nal l o g -
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 last q ua ntifia ble dr u g c o nce ntrati o n will be re p orte d 
(e xce pt i n bi oe q ui vale nce a n d bi oa vaila bility st u dies, w here o nl y t he o bser ve d para meters 
will be re p orte d) .


F i nal v 2, 2 3 J ul 2 0 2 0
             Pa ge 1 0 of 1 5
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 4 3 0 9 3
S p o ns or Refere nce J 2 Z -M C -P G A A
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 m eters wi t 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 s u bject or fr o m a 
s u bse q ue nt d ose peri o d f oll owi n g a s uita 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 o ns are B Q L to 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 pl ot .
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 omi 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 om n o n -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 nt ifia 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 n s at a sa mpli n g ti me e xcee di n g t he s a mpli 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.


F i nal v 2, 2 3 J ul 2 0 2 0
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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 4 3 0 9 3
S p o ns or Refere nce J 2 Z -M C -P G A A

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 ntifia 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 
estimate d wi t 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 ne d t o be a p pr o priate 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 usi o n of data w he n scie nt ificall 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 om a nal ysis.   T he f o ll owi n g 
met h o d ol o g y  will n ot 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 d e d fr o m a nal ysis if a n y of t he fol l 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 ntratio ns f or t hat i n di vi d ual i n 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 mp 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 uest i ona ble dat u m  that d oes n ot satisf y t he a b o ve criteria, 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.
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 t est.  Dat a will be 
a nal yze d wit h a n d wit h o ut t he at ypical 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 wil l be use d t o c o m p are t he at ypical val ue t o ot h er 
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.
F i n d t he most e xtr e m e v alu e fr o m t he arit h metic mea n of t he l og tra nsf or me d val ues 
a n d e xcl u de t hat valu e f r o m t he dataset.
c.
Calc ulate t he l ower a n d u p per b o u n ds of  the ra n ge defi ne d b y t he arit hmet 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 xtr e me val ue is wi t hi n t he ra n ge of  arit h m etic mea n ± 3 * S D, t he n it is n ot a n 
o utlier a n d will be re tai ne d i n t he dataset.


F i nal v 2, 2 3 J ul 2 0 2 0
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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 4 3 0 9 3
S p o ns or Refere nce J 2 Z -M C -P G A A
e.
If t he e xtr e me val ue is o utsi de t he ra n ge of  arit hmet ic 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 nt il all data 
r e mai ni n g i n t he dataset fall wi t hi n t he ra n ge of arit h met ic mea n ± 3 * S D of t he l og -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 o f 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 m et h o d ol o g y
All P K para meters will be s u m marize d b y treat me nt usi n g descri pti ve statist ics.
T he P K para meter esti mates will be e val uate d t o deli neate d ose pr o p orti o nalit y.  L o g-tra nsf or me d 
C ma x, a n d A U C (0 -∞) of  L Y 3 8 3 2 4 7 9 will be e val uate d usi n g a p o wer m o del  ( w here lo g -d ose a ct s 
as a n e x pla nat or y varia ble) t o esti mate rati os of d ose -n or m alize d ge o met ric mea ns a n d 
c orres p o n di n g 9 0 % c o nfi de nce i nter vals. I n a d diti o n, res ults of t he d ose pr o p orti o nality will be 
pl otte d. 
T he est i mate d rati o of d ose-n or malize d ge o metric mea ns of P K para meters bet wee n t he hi g hest 
a n d l owest d oses will be use d t o assess d ose pr o p orti o nalit y.
E xa m ple S A S c o de f or t he a nal ysis:
p r o c  m i x e d  d a t a = p k ;
m o d e l  l o g _ p k  =  l o g _ d o s e  /  a l p h a = 0 . 1  c l  s o l u t i o n  r e s i d u a l  d d f m = k r ;
e s t i m a t e  ' 7 0 0  m g '  
i n t e r c e p t  1  l o g _ d o s e  2 . 8 7 5 0 6 1 2 6
/  a l p h a = 0 . 1  c l ;  / * L o g  o f  7 0 0
* /
e s t i m a t e  ' 2 8 0 0  m g '  i n t e r c e p t  1  l o g _ d o s e  3 . 4 4 7 1 5 8 0 3  /  a l p h a = 0 . 1  c l ;  / * L o g  o f  2 8 0 0
* /
e s t i m a t e  ' 7 0 0 0  m g '  i n t e r c e p t  1  l o g _ d o s e  3 . 8 4 5 0 9 8 0 4
/  a l p h a = 0 . 1  c l ;  / * L o g  o f  7 0 0 0
* /
e s t i m a t e  ' 2 8 0 0
m g  -
2 5 0
m g '     l o g _ d o s e  0 . 9 7 0 0 3 6 7 9
/  a l p h a = 0 . 1  c l ;  / * D i f f e r e n c e  i n
l o g
v a l u e s  o f  7 0 0 0
a n d  7 0 0  * /
o d s  o u t p u t  s o l u t i o n f = e s t ;
o d s  o u t p u t  e s t i m a t e s = e s t i m s ;
r u n ;
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 se 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 verit y 
of  t he A E will be re p orte d i n t he list i 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 s u bject 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 
defi ne d as a n A E w hic h occ urs p ost d ose or w hic 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. 


F i nal v 2, 2 3 J ul 2 0 2 0
             Pa ge 1 3 of 1 5
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 4 3 0 9 3
S p o ns or Refere nce J 2 Z -M C -P G A A
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 s u bjects 
e x perie nci n g a n A E a n d t he perce nta ge of s u bjects 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  for Re g ulat or y  Act i vities ( Me d D R A) 
versi o n 2 3 . 0 s yste 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 usalit ies 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. O nset ti mes will be calc ulate d fr o m t he start of t he i nf usi o n.
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  ( Versio n  W H O D D 
M A R 2 0 B 3 ). C o nc o mita nt me dicat i on 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
t o get her wit h c ha n ges fr o m baseli ne, a n d liste d. Baseli ne is defi ne d as t he Da y  1 pre d ose 
assess me nt. A d dit i onall y , cli nical c he mistr y a n d h e m at olo g y 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 s u bject data list i n gs.
9. 4. 4
Vit al si g ns
V ital 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 nt e d b y tr e at me nt. 
V alu es f or i n di vi d ual s u bjects will be liste d.
9. 4. 5
Electr oc ar di o gr a m
All 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 s u bject e x perie nces ele vate d ala ni ne a mi n otra nsferase ( A L T) or a s partate a mi n otra nsferase 
( A S T) ≥3 × u p per li mit of n or mal ( U L N), al kali ne p h os p hatase ( A L P) ≥2 × U L N, or ele vate d t otal 
bilir u bi n ( T B L) ≥2 × U L N, li ver tests will be perf or me d t o c o nfir m t he a b n or malit y.  Ad di tio n al 
safety d at a m a y be c ollecte d if re q uire d, as defi ne d i n t he pr ot oc ol. W here a p plica ble, t he 
f oll owi n g will be prese nte d.
T he s u bjects’ li ver disease hist or y  a n d ass ociate d pers o n li ver disease hist or y data will be listed. 
A n y c o nc o mit a nt me d icatio ns that ha ve p ote ntial f or he pat ot o xicit y, i ncl u di n g aceta mi n o p he n 
will be liste d. Res ults fr o m a n y he patic mo ni t ori n g pr oce d ures, s uc h as a ma g netic res o na nce 
elast o gra p h y ( M R E) sca n, a n d bi o ps y assess me nts will be liste d, if p erfor m e d.


F i nal v 2, 2 3 J ul 2 0 2 0
             Pa ge 1 4 of 1 5
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 4 3 0 9 3
S p o ns or Refere nce J 2 Z -M C -P G A A
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 ol a n d recreati o 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 olo 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 s u bject data list i n gs.
9. 4. 7
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  foll 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. 8
I nf usio n -site re acti o ns
I nf usi on -site reactio n data will be liste d a n d s u m marize d b y  tr e at me nt i n fre q ue nc y ta bles.
T he se verit y of  all I S Rs will be assesse d usi n g t he Di visio n  of Aller g y a n d I nfect i ous Diseases 
( D AI D S) Ta ble f or Gra di n g t he Se verity of  Ad ul t a n d Pe diatric A d verse E ve nts, versi o n 2. 1 
(J ul y 2 0 1 7).
9. 4. 9
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 scre e ni n g, ser olo g y , a n d p oi nt-of -care test will be liste d , if 
a vaila ble.
9. 4. 1 0
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 1
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 statistical 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 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, Stati stical Pri nci ples 
f or Cli nical Trials ( E 9), 5 Fe br uar y 1 9 9 8.


F i nal v 2, 2 3 J ul 2 0 2 0
             Pa ge 1 5 of 1 5
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 4 3 0 9 3
S p o ns or Refere nce J 2 Z -M C -P G A A
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.
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 statist ics 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 data, e. g. t ma x , s h o ul d be re p orte d as recei ve d. N a n d perce nt a 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 s u bjects 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 i n 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.”.
1 4.
V E R SI O N HI S T O R Y
T he S A P Versi o n 2 was create d t o ca pt ure c ha n ges i ntr o d uce d b y t he t hree pr ot oc ol a me n d me nts 
t hat were p u blis he d si nce fi nalizat i on of S A P Versi o n 1 . T hese c ha n ges mai nl y affecte d 
Secti o n 5 of  t he S A P. A d diti onall y, mi n or w or di n g c ha n ge was a p plie d s o t hat t he Safet y 
a nal ysis p o p ulati o n matc hes t he w or di n g o f t he pr ot oc ol i n Sect i on 8. 


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