A Phase 1, Participant- and Investigator-blinded, Randomized, Single-dose Study to Investigate the Safety and Pharmacokinetics of Lebrikizumab in Healthy Chinese Participants
Phase: PHASE1
Conditions: Healthy
Sponsor: Eli Lilly and Company

Protocol Addendum J2T-MC-KGBV (Initial) 
A Phase 1, Participant- and Investigator-blinded, Randomized, Single-dose Study to 
Investigate the Safety and Pharmacokinetics of Lebrikizumab in Healthy Chinese Participants 
NCT06243198 
Approval Date: 01-Sep-2023 

CONFIDENTIAL 
Protocol number J2T-MC-KGBV 
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Title Page 
Confidential Information 
The information contained in this document is confidential and is intended for the use of clinical investigators. It is the property of 
Eli Lilly and Company or its subsidiaries and should not be copied by or distributed to persons not involved in the clinical 
investigation of lebrikizumab (LY3650150), unless such persons are bound by a confidentiality agreement with Eli Lilly and 
Company or its subsidiaries.  
Note to Regulatory Authorities: This document may contain protected personal data and/or commercially confidential information 
exempt from public disclosure. Eli Lilly and Company requests consultation regarding release/redaction prior to any public release. 
In the United States, this document is subject to Freedom of Information Act (FOIA) Exemption 4 and may not be reproduced or 
otherwise disseminated without the written approval of Eli Lilly and Company or its subsidiaries. 
Protocol Title: 
A Phase 1, Participant- and Investigator-blinded, Randomized, Single-dose Study to Investigate 
the Safety and Pharmacokinetics of Lebrikizumab in Healthy Chinese Participants  
Protocol Number: J2T-MC-KGBV  
Amendment Number: This is the initial protocol. 
Compound: Lebrikizumab (LY3650150) 
Brief Title: 
A study to investigate the safety and pharmacokinetics of a single subcutaneous dose of 
lebrikizumab compared with placebo in healthy Chinese participants  
Study Phase: 1  
Sponsor Name: Eli Lilly and Company 
Legal Registered Address: Eli Lilly and Company, Indianapolis, Indiana USA 46285 
Regulatory Agency Identifier Number(s): Not applicable  
Approval Date: Protocol Electronically Signed and Approved by Lilly on date provided below. 
Document ID: VV-CLIN-121708 
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Medical Monitor Name and Contact Information will be provided separately. 
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Table of Contents 
1.
Protocol Summary ..........................................................................................................6
1.1.
Synopsis ............................................................................................................................6
1.2.
Schema ..............................................................................................................................9
1.3.
Schedule of Activities (SoA) ..........................................................................................10
2.
Introduction ...................................................................................................................13
2.1.
Study Rationale ...............................................................................................................13
2.2.
Background .....................................................................................................................13
2.3.
Benefit/Risk Assessment ................................................................................................15
3.
Objectives and Endpoints ............................................................................................16
4.
Study Design ..................................................................................................................17
4.1.
Overall Design ................................................................................................................17
4.2.
Scientific Rationale for Study Design ............................................................................17
4.3.
Justification for Dose ......................................................................................................18
4.4.
End of Study Definition ..................................................................................................18
5.
Study Population ...........................................................................................................20
5.1.
Inclusion Criteria ............................................................................................................20
5.2.
Exclusion Criteria ...........................................................................................................21
5.3.
Lifestyle Considerations .................................................................................................24
5.3.1.
Meals and Dietary Restrictions .......................................................................................24
5.3.2.
Substance Use: Caffeine, Alcohol, and Tobacco ............................................................24
5.3.3.
Activity ...........................................................................................................................24
5.4.
Screen Failures ................................................................................................................24
5.5.
Criteria for Temporarily Delaying Randomization of a 
Participant .......................................................................................................................25
6.
Study Interventions and Concomitant Therapy ........................................................26
6.1.
Study Interventions Administered ..................................................................................26
6.1.1.
Administration Details ....................................................................................................26
6.2.
Preparation, Handling, Storage, and Accountability ......................................................26
6.3.
Assignment to Study Intervention ..................................................................................27
6.4.
Blinding ..........................................................................................................................27
6.5.
Study Intervention Compliance ......................................................................................28
6.6.
Dose Modification ..........................................................................................................28
6.7.
Continued Access to Study Intervention after the End of the 
Study ...............................................................................................................................28
6.8.
Treatment of Overdose ...................................................................................................28
6.9.
Prior and Concomitant Therapy ......................................................................................29
7.
Discontinuation of Study Intervention and Participant
Discontinuation/Withdrawal........................................................................................30
7.1.
Discontinuation of Study Intervention ............................................................................30
7.2.
Participant Discontinuation/Withdrawal from the Study ................................................30
7.3.
Lost to Follow-up............................................................................................................30
8.
Study Assessments and Procedures.............................................................................31
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8.1. 
Efficacy Assessments .....................................................................................................31 
8.2. 
Safety Assessments .........................................................................................................31 
8.2.1. 
Physical Examinations ....................................................................................................31 
8.2.2. 
Vital Signs .......................................................................................................................31 
8.2.3. 
Electrocardiograms .........................................................................................................32 
8.2.4. 
Clinical Safety Laboratory Assessments ........................................................................32 
8.2.5. 
Pregnancy Testing ...........................................................................................................33 
8.2.6. 
Safety Monitoring ...........................................................................................................33 
8.3. 
Adverse Events, Serious Adverse Events, and Product 
Complaints ......................................................................................................................36 
8.3.1. 
Timing and Mechanism for Collecting Events ...............................................................37 
8.3.2. 
Pregnancy ........................................................................................................................38 
8.3.3. 
Adverse Events of Special Interest .................................................................................39 
8.4. 
Pharmacokinetics ............................................................................................................40 
8.4.1. 
Bioanalysis ......................................................................................................................40 
8.5. 
Pharmacodynamics .........................................................................................................40 
8.6. 
Genetics ..........................................................................................................................40 
8.7. 
Biomarkers ......................................................................................................................40 
8.8. 
Immunogenicity Assessments.........................................................................................40 
8.9. 
Health Economics ...........................................................................................................40 
9. 
Statistical Considerations .............................................................................................41 
9.1. 
Statistical Hypothesis ......................................................................................................41 
9.2. 
Analyses Sets ..................................................................................................................41 
9.3. 
Statistical Analyses .........................................................................................................41 
9.3.1. 
General Considerations ...................................................................................................41 
9.3.2. 
Safety Analysis ...............................................................................................................42 
9.3.3. 
Pharmacokinetic Analysis ...............................................................................................42 
9.3.4. 
Immunogenicity Analysis ...............................................................................................42 
9.4. 
Interim Analysis ..............................................................................................................43 
9.5. 
Sample Size Determination ............................................................................................43 
10. 
Supporting Documentation and Operational Considerations ..................................44 
10.1. 
Appendix 1: Regulatory, Ethical, and Study Oversight 
Considerations ................................................................................................................44 
10.1.1. Regulatory and Ethical Considerations ...........................................................................44 
10.1.2. Informed Consent Process ..............................................................................................44 
10.1.3. Data Protection................................................................................................................45 
10.1.4. Dissemination of Clinical Study Data.............................................................................45 
10.1.5. Data Quality Assurance ..................................................................................................46 
10.1.6. Source Documents ..........................................................................................................47 
10.1.7. Study and Site Start and Closure ....................................................................................48 
10.1.8. Publication Policy ...........................................................................................................48 
10.1.9. Sample Retention ............................................................................................................49 
10.2. 
Appendix 2: Clinical Laboratory Tests ...........................................................................50 
10.2.1. Blood Sampling Summary ..............................................................................................52 
10.2.2. Laboratory Samples to be Obtained at the Time of a Systemic 
Hypersensitivity Event ....................................................................................................52 
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10.3. 
Appendix 3: Adverse Events and Serious Adverse Events: 
Definitions and Procedures for Recording, Evaluating, 
Follow-up, and Reporting ...............................................................................................54 
10.3.1. Definition of AE .............................................................................................................54 
10.3.2. Definition of SAE ...........................................................................................................55 
10.3.3. Definition of Product Complaints ...................................................................................56 
10.3.4. Recording and Follow-Up of AE and/or SAE and Product 
Complaints ......................................................................................................................56 
10.3.5. Reporting of SAEs ..........................................................................................................58 
10.3.6. Regulatory Reporting Requirements ...............................................................................58 
10.4. 
Appendix 4: Contraceptive and Barrier Guidance ..........................................................59 
10.4.1. Definitions.......................................................................................................................59 
10.4.2. Contraception Guidance..................................................................................................60 
10.5. 
Appendix 5: Liver Safety: Suggested Actions and Follow-up 
Assessments ....................................................................................................................62 
10.6. 
Appendix 6: Provisions for Changes in Study Conduct During 
Exceptional Circumstances .............................................................................................64 
10.7. 
Appendix 7: Clinical Laboratories and Specimen Disposal Units .................................67 
10.8. 
Appendix 8: Abbreviations and Definitions ...................................................................69 
11. 
References ......................................................................................................................72 
 
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1. 
Protocol Summary  
1.1. 
Synopsis  
Protocol Title: A Phase 1, Participant- and Investigator-blinded, Randomized, Single-dose 
Study to Investigate the Safety and Pharmacokinetics of Lebrikizumab in Healthy Chinese 
Participants 
Brief Title: A study to investigate the safety and pharmacokinetics of a single subcutaneous dose 
of lebrikizumab compared with placebo in healthy Chinese participants  
Regulatory Agency Identifier Number: Not applicable  
Rationale: Study J2T-MC-KGBV will assess the safety, tolerability, and pharmacokinetics (PK) 
of 250- and 500-mg subcutaneous (SC) single doses of lebrikizumab (LY3650150) in healthy 
Chinese participants.
 
 
 
Objectives and Endpoints: 
Objectives 
Endpoints 
Primary 
 
To describe the safety of single SC doses of 
250 mg and 500 mg lebrikizumab in healthy 
Chinese participants 
Incidence of TEAEs and SAEs 
Secondary 
 
To evaluate the PK of single SC doses of 
250 mg and 500 mg lebrikizumab in healthy 
Chinese participants 
Cmax, AUC(0-6(-tlast) of 
lebrikizumab 
Abbreviations: AUC(0-tlast) = area under the concentration versus time curve from time zero to t, where t is the last 
time point with a measurable concentration; AUC(0-6,/(,.")((.,.#)(0,-/-.#'/,0 ,)'.#'
zero to infinity; Cmax = maximum observed drug concentration; PK = pharmacokinetic; SAE = serious adverse 
event; SC = subcutaneous; TEAE = treatment-emergent adverse events.  
Overall Design: 
This is a Phase 1, participant- and investigator-blinded, randomized, placebo-controlled, single-
dose study to investigate the safety, tolerability, and PK of lebrikizumab in healthy Chinese 
participants. 
Brief Summary: 
Participants will be assigned sequentially into 1 of 2 cohorts, each with 12 participants. Within 
each cohort, participants will be randomized in a blinded manner to lebrikizumab or placebo. 
The planned doses are as follows: 
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 Cohort 1: single 250 mg dose of lebrikizumab or placebo via SC injection (n=12; 
10 lebrikizumab, 2 placebo) 
 Cohort 2: single 500 mg dose of lebrikizumab or placebo via SC injection (n=12; 
10 lebrikizumab, 2 placebo) 
Screening period 
All participants will be screened within 28 days prior to enrollment. 
Inpatient period 
Eligible participants will be admitted to the clinical research unit (CRU) on Day -1. On Day 1, 
participants will be randomized, and will receive either lebrikizumab or placebo via SC injection. 
Participants may be allowed to leave the CRU after completing assessments on Day 8, or later at 
the investigator’s discretion.  
Follow-up period 
Participants will return for PK and immunogenicity sampling and safety assessments at 
predefined times up to approximately 120 days postdose.  
Safety and tolerability will be assessed through safety laboratory assessments, 12-lead 
electrocardiograms, vital sign measurements, recording of adverse events, and physical 
examinations. 
Study Population: 
Overtly healthy male and female participants aged 18 to 65 years, inclusive, with a body mass 
index within the range of 18.0 to 28.0 kg/m2, inclusive, who are native Chinese and born in 
China, where the participant’s biological parents and all 4 of the participant’s biological 
grandparents are of Chinese origin. Due to effect of body weight on PK, enrolment of 
participants with similar body weights between the cohorts is preferred. 
Number of Participants: 
Approximately 24 healthy Chinese participants who have satisfied the entry criteria and 
completed all screening assessments will be enrolled to ensure at least 20 evaluable participants 
complete the study. 
Intervention Groups and Duration: 
The duration of the study is approximately 21 weeks, and will consist of 3 periods: 
 Screening period: Day -28 to Day -2 
 Inpatient period: Day -1 to Day 8 
o single SC dose of 250 mg or 500 mg lebrikizumab, or placebo, on Day 1  
 Follow-up period: discharge until Day 120 ± 3 days. 
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Ethical Considerations of Benefit/Risk: 
No clinically significant safety concerns have been identified to date for lebrikizumab up to the 
highest SC dose given of 500 mg. The highest SC dose of 500 mg has been investigated in Study 
J2T-DM-KGAS/ILR4660g, a Phase 2 dose-ranging study to evaluate 125, 250, or 500 mg SC of 
lebrikizumab in adult participants with stable asthma. The safety findings from Study KGAS 
showed that lebrikizumab was generally well tolerated. Although there was a greater proportion 
of lebrikizumab-treated participants in the 500 mg dose group, 75% had 1 or more AEs 
compared with the 2 lower dose groups, 64.2% in both the 125- and 250-mg dose groups; most 
AEs were mild or moderate in severity, and of the AEs with the highest severity, most were 
considered not related to the study drug. No SAEs related to the drug or deaths were reported in 
the 500-mg dose group. 
There is no anticipated therapeutic benefit for the participants in this study. However, 
participants may benefit from the screening procedures, through detection of unknown health 
issues, even if they receive no therapeutic benefit from the study.  
  
Data Monitoring Committee: No 
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1.2. 
Schema  
 
Abbreviations: CRU = clinical research unit; ED = early discontinuation.  
 
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1.3. 
Schedule of Activities (SoA)  
 
Screening 
Inpatient Period 
Follow-up Period 
Comments 
Visit 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
11 
12 
13 
14 
15 
 
Day 
-28 to -2  
-1 
1 
2 
5 8 
11 
±
1 
15 
±
2 
22 
±
2 
29 
±
2 
36 
±
2 
43 
±2 
50 
±2 
57 
±2 
64 
±2 
71 
±3 
85 
±3 
99
±3 
120 
±3 or 
ED 
 
Procedure 
Informed consent 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medical history 
and demographics 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Review and 
confirm inclusion/ 
exclusion criteria 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Admission to 
CRU 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Discharge from 
CRU 
 
 
 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Outpatient visit 
X 
 
 
 
 
 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
 
Randomization 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
. 
Height 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Weight and BMI 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
 
Ultrasound 
examination 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Ultrasound 
examination (for 
example, 
abdominal) as 
deemed clinically 
necessary. 
Serology 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
See Section 10.2 
TB testing 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
See Section 10.2 
Chest x-ray 
(posterior-anterior 
view) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
A lateral chest 
x-ray may be 
performed if 
clinically or 
radiologically 
indicated. 
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Ethanol test and 
urine drug screen 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
May be repeated at 
additional time 
points at 
investigator’s 
discretion. 
FSH (females 
only) 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
See Sections 10.2 
and 10.4. 
Pregnancy test  
(WOCBP only) 
X 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Serum test at 
screening only. 
Urine test at all 
other time points. 
See Sections 10.2 
and 10.4. 
Lebrikizumab or 
placebo 
administration 
 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
See Section 6.1. 
Physical 
examination 
X 
X 
 
X 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
Full physical 
examination at 
screening or 
Day -1. 
Symptom-directed 
examinations at 
other times, and at 
investigator’s 
discretion. 
Vital signs 
(sitting pulse rate 
and blood 
pressure) and 
body temperature 
X 
X 
P, 
3h 
24h 
X X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
Predose D1 
conducted within 
2h predose. 
Postdose 
assessment 3±1h. 
Time points may 
be added at 
investigator’s 
discretion. 
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Abbreviations: AE = adverse event; BMI = body mass index; CRU = clinical research unit; D = day; ECG = electrocardiogram; ED = early discontinuation; 
FSH = follicle-stimulating hormone; h = hour; ISR = injection site reaction; PK = pharmacokinetic; P = predose; TB = tuberculosis; WOCBP = women of 
childbearing potential.  
Note: if multiple procedures take place at the same time point, the following order of the procedure should be used: ECG, vital signs, and venipuncture. 
Single 12-lead 
ECG (supine) 
X 
 
P, 
3h 
24h 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
X 
May be obtained 
at additional times, 
if deemed 
clinically 
necessary. 
Hematology, 
chemistry, and 
urinalysis 
X 
X 
P 
X 
X  
 
X 
 
X 
 
X 
 
X 
 
X 
X 
 
X 
D1 collected 
within 2h predose. 
See Section 10.2.  
AE and 
concomitant 
medication 
recording 
X 
X 
X 
X 
X X X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 
If an AE of an ISR 
is reported, see 
Section 8.2.6.2. 
Lebrikizumab PK 
sample 
 
 
P 
24h 
X X  X 
X 
X 
X 
 
X 
 
X 
 
X 
X 
 
X 
D1 collected 
within 2h predose. 
Immunogenicity 
sample 
 
 
P 
 
 
 
 
X 
 
X 
 
 
 
 
 
 
X 
 
X 
D1 collected 
within 2h predose. 
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2. 
Introduction  
2.1. 
Study Rationale  
Study J2T-MC-KGBV (KGBV) will assess the safety, tolerability, and PK of 250- and 500-mg 
SC single doses of lebrikizumab (LY3650150) in healthy Chinese participants.
 
 
  
2.2. 
Background  
Lebrikizumab (LY3650150) is a monoclonal antibody based on the human immunoglobulin G4 
antibody stabilized by a mutated Fc region. Lebrikizumab binds specifically to soluble IL-13 and 
blocks IL-13 signaling through the IL-4 receptor alpha/IL-13 receptor alpha 1 pathway, thereby 
preventing the downstream effects of human IL-13 with high potency.  
Lebrikizumab has been investigated for the treatment of 
 atopic dermatitis (AD) 
 asthma 
 chronic obstructive pulmonary disease 
 idiopathic pulmonary fibrosis, and  
 refractory Hodgkin lymphoma.  
Currently, lebrikizumab is being actively developed for the treatment of AD. 
A detailed description of the chemistry, pharmacology, efficacy, and safety of lebrikizumab is 
provided in the IB. 
Safety summary 
As of the IB cutoff date of 01 May 2023, 552 healthy participants and an estimated 
6360 participants have been exposed to at least 1 dose of lebrikizumab. Single IV doses up to 10 
mg/kg and multiple SC doses up to 500 mg have been administered to humans in clinical trials 
without dose-limiting toxicity. 
Healthy participants 
Lebrikizumab has been evaluated in 6 healthy participant studies. Single IV doses administered 
comprised 0.1, 0.3, 1.0, 3.0, and 5.0 mg/kg. Single SC doses administered comprised 1 mg/kg, 
and 37.5, 125, 250, and 375 mg. 
No deaths were reported in healthy participant studies. Eight treatment-emergent SAEs were 
reported in lebrikizumab-treated participants. All events were assessed by the investigator as not 
related to lebrikizumab. No SAE preferred term was reported in more than 1 participant. No 
participants discontinued the study treatment due to AEs. The most commonly reported TEAE in 
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greater than 5% of participants was headache. The majority of events were mild or moderate in 
severity.  
Participants with atopic dermatitis, asthma, and other indications 
Lebrikizumab has been evaluated in 2562 participants with AD, 3321 participants with asthma, 
and 477 participants with other indications. Multiple SC doses administered included 37.5 to 500 
mg, and IV doses of 0.1 to 10 mg/kg. In participants with AD, the overall frequency of 
participants with at least 1 TEAE was similar in the lebrikizumab and placebo groups. 
Conjunctivitis, nasopharyngitis, and headache were the most frequently reported events for 
lebrikizumab-treated participants. Most TEAEs were mild or moderate in severity. The 
frequency of participants reporting at least 1 SAE was 1.1% in the lebrikizumab group and 1.8% 
in the placebo group. No SAEs were reported by more than 1 participant. Four deaths were 
reported in the lebrikizumab treatment group, none of which were assessed by the investigator as 
related to treatment. The overall safety profile of lebrikizumab in other indications was 
consistent with the safety profile of lebrikizumab in the AD population, with the exception of 
events that have been observed in the underlying disease state being studied or known associated 
comorbidities. 
Pharmacokinetic summary 
In clinical studies to date, lebrikizumab has exhibited linear PK in humans with no 
target-mediated drug disposition over a dose range of 37.5 to 500 mg. A 2-compartment 
population PK model with first-order absorption and linear clearance best described the PK of 
lebrikizumab in participants with AD and healthy participants over this dose range. Maximal 
serum concentrations were generally achieved 7 to 8 days after SC administration. Based on the 
population PK model, the elimination half-life of lebrikizumab was approximately 25 days, the 
estimated bioavailability following SC administration was 86%, and exposure was dose 
proportional over a dose range of 37.5 to 500 mg SC. Clearance was approximately 0.154 L/day, 
with 24.7% inter-individual variability.  
The PK profiles were compared for the 2 maintenance dosing regimens studied in Phase 3, 
lebrikizumab 250 mg Q2W and 250 mg Q4W, following the 500 mg loading doses at Weeks 0 
and 2. The median lebrikizumab concentrations were approximately 50% lower for 250 mg Q4W 
dosing compared to 250 mg Q2W. Some overlap in lebrikizumab concentrations was predicted 
in comparison of the 5th and 95th percentiles between 250 mg Q2W and 250 mg Q4W. 
Based on the evaluation of the influence of intrinsic and extrinsic factors on lebrikizumab PK 
across time, no significant effects of the following covariates were identified: age, sex, race, 
injection site location, disease state, and markers of hepatic and renal function (ALT, AST, and 
estimated glomerular filtration rate). Body weight was the only factor identified as a significant 
covariate on lebrikizumab PK, but the Exposure-Response model suggests no dose adjustment 
on the basis of body weight is needed for the population in the AD studies.  
The PK of lebrikizumab in Japanese and White healthy participants was investigated in a Phase 1 
study J2T-DM-KGAZ (KGAZ)/GB25741 following single SC administration of 125, 250, and 
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375 mg doses. Based on this study, there were no meaningful differences in PK between 
Japanese and White participants at all 3 dose levels.  
Anti-lebrikizumab antibodies 
In the completed studies of participants with AD, 2.8% to 3.4% of participants developed ADA. 
In general, the presence of anti-lebrikizumab antibodies had no apparent impact on PK results, 
and overall there was no relationship between anti-lebrikizumab antibody status and efficacy or 
safety events. In a completed Phase 1 study of healthy participants, the incidence of TE ADA+ 
participants ranged between 4.2% and 5.0% depending on the adopted injection system, 
autoinjector or prefilled syringe, respectively. Due to the low immunogenicity, no conclusion 
could be drawn on the impact of TE ADA on safety. 
2.3. 
Benefit/Risk Assessment  
This study will evaluate single SC doses of 250 and 500 mg lebrikizumab. The justification of 
these doses can be found in Section 4.3.  
No clinically significant safety concerns have been identified to date for lebrikizumab up to the 
highest SC dose given of 500 mg as described in Section 2.2. The highest SC dose of 500 mg has 
been investigated in Study J2T-DM-KGAS/ILR4660g, a Phase 2 dose-ranging study to evaluate 
125, 250, or 500 mg SC of lebrikizumab in adult participants with stable asthma (Noonan et al, 
2013). The safety findings from Study KGAS showed that lebrikizumab was generally well 
tolerated. Although there was a greater proportion of lebrikizumab-treated participants in the 500 
mg dose group, 75% had 1 or more AEs compared with the 2 lower dose groups, 64.2% in both 
the 125- and 250-mg dose groups; most AEs were mild or moderate in severity, and of the AEs 
with the highest severity, most were considered not related to the study drug. No SAEs related to 
the drug or deaths were reported in the 500-mg dose group. 
There is no anticipated therapeutic benefit for the participants in this study. However, 
participants may benefit from the screening procedures, through detection of unknown health 
issues, even if they receive no therapeutic benefit from the study.  
Detailed information about the known and expected benefits, risks, and reasonably expected AEs 
of lebrikizumab may be found in the IB.  
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3. 
Objectives and Endpoints   
Objectives 
Endpoints 
Primary 
 
To describe the safety of single SC doses of 
250 mg and 500 mg lebrikizumab in healthy 
Chinese participants 
Incidence of TEAEs and SAEs 
Secondary 
 
To evaluate the PK of single SC doses of 
250 mg and 500 mg lebrikizumab in healthy 
Chinese participants 
Cmax, AUC(0-∞), and AUC(0-tlast) of 
lebrikizumab 
Exploratory 
 
To assess the immunogenicity of single SC 
doses of 250 mg and 500 mg lebrikizumab in 
healthy Chinese participants 
Incidence of TE ADA 
Abbreviations: AUC(0-tlast) = area under the concentration versus time curve from time zero to t, where t is the last 
time point with a measurable concentration; AUC(0-∞) = area under the concentration versus time curve from time 
zero to infinity; Cmax = maximum observed drug concentration; PK = pharmacokinetic; SAE = serious adverse 
event; SC = subcutaneous; TE ADA = treatment-emergent anti-drug antibody; TEAE = treatment-emergent adverse 
events.  
 
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4. 
Study Design  
4.1. 
Overall Design  
This is a Phase 1, participant- and investigator-blinded, randomized, placebo-controlled, single-
dose study to investigate the safety, tolerability, and PK of lebrikizumab in healthy Chinese 
participants. 
Approximately 24 healthy Chinese participants who have satisfied the entry criteria and 
completed all screening assessments will be enrolled to ensure at least 20 evaluable participants 
complete the study. Due to effect of body weight on PK, enrolment of participants with similar 
body weights between the cohorts is preferred. Participants will be assigned sequentially into 1 
of 2 cohorts, each with 12 participants. Within each cohort, participants will be randomized in a 
blinded manner to lebrikizumab or placebo. The planned doses are as follows: 
 Cohort 1: single 250 mg dose of lebrikizumab or placebo via SC injection (n=12; 
10 lebrikizumab, 2 placebo) 
 Cohort 2: single 500 mg dose of lebrikizumab or placebo via SC injection (n=12; 
10 lebrikizumab, 2 placebo) 
The duration of the study is approximately 21 weeks, and will consist of 3 periods: 
 Screening period: Day -28 to Day -2 
 Inpatient period: Day -1 to Day 8 
o single SC dose on Day 1 
 Follow-up period: discharge until Day 120 ± 3 days. 
Screening period 
All participants will be screened within 28 days prior to enrollment. 
Inpatient period 
Eligible participants will be admitted to the CRU on Day -1. On Day 1, participants will be 
randomized, and will receive either lebrikizumab or placebo via SC injection. 
Participants may be allowed to leave the CRU after completing assessments on Day 8, or later at 
."#(0-.#!.),;-#-,.#)( 
Follow-up period 
Participants will return for PK and immunogenicity sampling and safety assessments at 
predefined times up to approximately 120 days postdose.  
Safety and tolerability will be assessed through safety laboratory assessments, 12-lead ECGs, 
vital sign measurements, recording of AEs, and physical examinations.  
4.2. 
Scientific Rationale for Study Design  
 
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4.3. 
Justification for Dose  
 
 
 
 
 
 
 
 
 
 
 
  
 
 
 
 
 
 
 
 
 
 
 
4.4. 
End of Study Definition  
The end of the study is defined as the date of the last visit of the last participant in the study. 
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A participant is considered to have completed the study if the participant has completed all 
periods of the study including the last visit or the last scheduled procedure shown in the SoA for 
the last participant. 
 
 
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5. 
Study Population  
Participant eligibility for enrollment in the study is based on the criteria listed in this section. The 
inclusion and exclusion criteria used to determine eligibility should only apply at screening or 
other specified visits, and not continuously throughout the study. 
Prospective approval of protocol deviations to recruitment and enrollment criteria, also known as 
protocol waivers or exemptions, is not permitted. 
5.1. 
Inclusion Criteria  
Participants are eligible to be included in the study only if all of the following criteria apply: 
Age 
1. Participant must be 18 to 65 years of age, inclusive, at the time of signing the informed 
consent. 
Type of participant and disease characteristics 
2. Are overtly healthy as determined by medical evaluation including medical history, 
physical examination, safety laboratory assessments, ECGs, and vital signs. 
3. Participants must be native Chinese and born in China, where the participant’s biological 
parents and all 4 of the participant’s biological grandparents are of Chinese origin. 
4. Have safety laboratory assessment results within normal reference range for the 
population or investigative site, or results with acceptable deviations that are judged to be 
not clinically significant by the investigator.  
5. Have venous access sufficient to allow for blood sampling as per the protocol.  
6. Agree not to donate blood or plasma until after the end of their participation in the study. 
7. Are reliable and willing to make themselves available for the duration of the study and 
are willing to follow study procedures. 
Weight 
8. Have a body mass index within the range of 18.0 to 28.0 kg/m2, inclusive. 
Sex and contraceptive/barrier requirements 
9.  Male or female 
 Males may participate in this study. No male contraception is required except in 
compliance with specific local government study requirements.  
 Females of childbearing potential and females not of childbearing potential may 
participate in this study.  
Contraceptive use by participants should be consistent with local regulations regarding the 
methods of contraception for those participating in clinical studies. For the contraception 
requirements of this protocol, see Section 10.4.  
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Informed consent 
10. Are capable of giving signed informed consent as described in Section 10.1, which 
includes compliance with the requirements and restrictions listed in the ICF and in this 
protocol. 
5.2. 
Exclusion Criteria  
Participants are excluded from the study if any of the following criteria apply: 
Medical conditions 
11. Have known allergies to lebrikizumab, related compounds, or any components of the 
formulation, or history of anaphylaxis as defined by the Sampson criteria (Sampson et al. 
2006). 
12. Have an abnormality in the 12-lead ECG that, in the opinion of the investigator, increases 
the risks associated with participating in the study or may confound ECG data analysis.  
13. Have an abnormal blood pressure or pulse rate as determined to be clinically significant 
by the investigator.  
14. Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, 
endocrine, hematological, or neurological disorders capable of significantly altering the 
absorption, metabolism, or elimination of drugs; of constituting a risk when taking the 
investigational product; or of interfering with the interpretation of data.  
15. Have a history or presence of psychiatric disorders deemed clinically significant by the 
investigator.  
16. Have significant allergies to monoclonal antibodies.  
17. Clinically significant multiple or severe drug allergies, or severe posttreatment 
hypersensitivity reactions, including, but not limited to, erythema multiforme major, 
linear immunoglobulin A dermatosis, toxic epidermal necrolysis, history of anaphylaxis, 
and exfoliative dermatitis.  
18. Current or chronic history of liver disease. This includes, but is not limited to, hepatitis 
virus infections, drug- or alcohol-related liver disease, nonalcoholic steatohepatitis, 
autoimmune hepatitis, hemochromatosis, Wilson’s disease, α-1 antitrypsin deficiency, 
primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease 
considered clinically significant by the investigator.  
19. Known hepatic or biliary abnormalities, with the exception of Gilberts syndrome or 
asymptomatic gallstones.  
20. Have donated blood of more than 500 mL within the previous 4 weeks of study 
screening.  
21. 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. 
22. Have had breast cancer within the past 10 years. 
23. Are females who are pregnant or intend to become pregnant, or lactating. 
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Prior/concomitant therapy 
24. Have received treatment with biologic agents, such as monoclonal antibodies, including 
marketed drugs, within 3 months or 5 half-lives, whichever is longer, prior to dosing. 
25. Have previously completed or withdrawn from this study or any other study investigating 
lebrikizumab. 
26. Have used or intend to use over-the-counter, prescription medication including herbal 
medications and traditional Chinese medicines within 7 days, or 14 days if the drug is a 
potential enzyme inducer, or 5 half-lives, whichever is longer, prior to dosing. Stable 
doses of hormone contraceptives, hormone-replacement therapy or thyroid replacement 
are permitted, at the discretion of the investigator. Supplements, for example vitamin 
supplements, may be permitted at the discretion of the investigator. 
27. Have received a live vaccine, including attenuated live vaccines, within 12 weeks prior to 
screening or plan to receive such vaccines during the study. It is suggested that 
participants do not receive non-live or inactivated vaccinations from 2 weeks prior to 
until 2 weeks after lebrikizumab dosing. 
Prior or concurrent clinical study experience 
28. Are currently enrolled in any other 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 trial involving an investigational product within 30 days or 
5 half-lives, whichever is longer, prior to screening. If the clinical trial involved treatment 
with biologic agents, such as monoclonal antibodies, including marketed drugs, at least 
3 months or 5 half-lives, whichever is longer, should have elapsed prior to dosing. 
Diagnostic assessments 
30. Regularly use known drugs of abuse or show positive findings on drug screening.  
31. Show evidence of human immunodeficiency virus infection or positive human 
immunodeficiency virus antibodies.  
32. Have a positive HCV antibody test. Participants with a positive HCV antibody test at 
screening can be included only if a confirmatory HCV RNA test is negative.  
33. Show evidence of hepatitis B and/or positive hepatitis B surface antigen or hepatitis B 
core antibody.  
34. Show evidence of active or latent TB, as documented through  
 medical history 
 examination 
 posterior to anterior chest x-rays read by a radiologist, pulmonologist, or 
designee; a lateral chest x-ray may be performed if clinically or radiologically 
indicated, or 
 positive, not indeterminate, QuantiFERON®-TB Gold test or T-SPOT® TB test or 
have had household contact with a person with active TB, unless appropriate and 
documented prophylaxis treatment has been given. If a repeat test is also 
indeterminate, the participant will not be eligible. Participants with any history of 
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active TB are excluded from the study, regardless of previous or current TB 
treatments. The choice to perform a QuantiFERON-TB Gold test or a T-SPOT TB 
test will be made by the investigator according to local standard of care.  
35. ALT or AST greater than 1.5 × ULN.  
36. Total bilirubin greater than 1.5 × ULN. Isolated bilirubin greater than 1.5 × ULN is 
acceptable if TBL is fractionated and direct bilirubin is less than 35%.  
37. Absolute eosinophil count greater than ULN.  
Infections  
38. Have had a serious infection, such as pneumonia, cellulitis, sepsis; have been hospitalized 
or have received IV antibiotics for an infection within 12 weeks prior to Day 1; have had 
a serious bone or joint infection within 24 weeks prior to Day 1; have ever had an 
infection of an artificial joint; or are immunocompromised to an extent that participation 
in the study would pose an unacceptable risk to the participant as determined by the 
investigator.  
39. Have or have had an infection typical of an immunocompromised host or that occurs with 
increased incidence in an immunocompromised host, including, but not limited to, 
Pneumocystis jirovecii pneumonia, histoplasmosis, or coccidioidomycosis, or have a 
known immunodeficiency.  
40. Have or have had a herpes simplex infection, herpes zoster infection, or any other 
clinically apparent varicella zoster virus infection within 12 weeks of Day 1.  
41. Have had any other active or recent infection within 4 weeks of Day 1 that, in the opinion 
of the investigator, would pose an unacceptable risk to the participant if participating in 
the study; these participants may be rescreened once at least 4 weeks after documented 
resolution of symptoms.  
Other exclusion criteria 
42. Are Lilly employees or are employees of a third-party organization involved with the 
study. 
43. Are investigator site personnel directly affiliated with this study or their immediate 
families. Immediate family is defined as a spouse, parent, child, or sibling, whether 
biological or legally adopted. 
44. Have an average weekly alcohol intake exceeding greater than 21 units for males or 
greater than 14 units for females. One unit is equivalent to 8 g of alcohol, which is 
equivalent to a half pint, approximately 240 mL, of beer, one 125 mL glass of wine, or 
one 25 mL measure of spirits. 
45. Are unwilling to stop alcohol consumption 24 hours prior to each study visit. 
46. Smoke more than 10 cigarettes per day or the equivalent including electronic cigarettes or 
are unable to abide by CRU smoking restrictions. 
47. Have excessive tattoos, scars, moles, skin hyperpigmentation, birth marks, or stretch 
marks over either arm, either thigh, or either side of the abdomen that would interfere 
with injection-site assessments. 
48. In the opinion of the investigator, are unsuitable for inclusion in the study. 
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5.3. 
Lifestyle Considerations  
Throughout the study, participants may undergo medical assessments and review of compliance 
with requirements before continuing in the study. 
5.3.1. 
Meals and Dietary Restrictions  
Participants will receive a light breakfast on the morning of Day 1 prior to dosing. Standard 
meals will be provided at all other times while participants are resident at the CRU, per the 
CRU’s policy. 
5.3.2. 
Substance Use: Caffeine, Alcohol, and Tobacco  
Caffeine 
Participants will not be allowed to consume caffeinated products during study visits and while 
resident at the CRU, but otherwise participants will be allowed to maintain their regular caffeine 
consumption. 
Alcohol 
Alcohol consumption is not permitted while participants are resident at the CRU and for 
24 hours prior to each study visit. Alcohol intake during outpatient periods should not exceed 
3 units per day for males or 2 units per day for females.  
Tobacco 
Participants must abide by the CRU smoking restrictions during study visits and while resident at 
the CRU. 
5.3.3. 
Activity  
Exercise 
Participants will be advised to maintain their regular levels of physical activity or exercise; 
however, they should not undertake vigorous or prolonged exercise within 48 hours prior to any 
visit in which laboratory safety tests will occur. While certain study procedures are in progress at 
the site, participants may be required to remain recumbent or sitting. 
Blood or blood products donation  
Study participants should be instructed not to donate blood or blood products during the study 
until the end of study participation. 
5.4. 
Screen Failures  
A screen failure occurs when a participant who consents to participate in the clinical study is not 
subsequently assigned to study intervention.  
Rescreening is not permitted. Repeating of laboratory tests during the screening period or 
repeating screening tests to comply with the protocol-designated screening period does not 
constitute rescreening. 
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5.5. 
Criteria for Temporarily Delaying Randomization of a Participant  
Not applicable.  
 
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6. 
Study Interventions and Concomitant Therapy  
Study intervention is defined as any medicinal products or medical devices intended to be 
administered to or used by a study participant according to the study protocol.  
6.1. 
Study Interventions Administered  
This table lists the interventions used in this clinical study. 
Intervention Name 
Lebrikizumab 
Placebo 
Dosage Formulation 
250 mg (125 mg/mL), 2 mL solution for 
injection in a prefilled syringe with needle 
safety device 
Placebo solution in a prefilled syringe 
with needle safety device 
Dosage Levels 
Cohort 1: 250 mg (1 injection of 250 mg) 
Cohort 2: 500 mg (2 injections of 250 mg) 
Not applicable 
Route of Administration 
Subcutaneous 
Subcutaneous 
Dosing Instructions 
Single dose administration 
Single dose administration 
Packaging and Labeling 
Study interventions will be supplied by the sponsor or its designee in accordance 
with current Good Manufacturing Practice. Study interventions will be labeled as 
appropriate for country requirements. 
6.1.1. 
Administration Details  
Lebrikizumab or placebo will be administered by the investigator or designee, using a prefilled 
syringe with needle safety device. Each prefilled syringe is intended for a single 2 mL dose, 
250 mg, administered subcutaneously in the abdomen, thigh, or back of the upper arm. 
Whenever possible, study drug administration should be carried out by the same personnel. The 
location of the injection(s) will be recorded. Multiple injections making up a single dose for 
Cohort 2 should be apart from each other, so ISRs, if any, can be observed separately. 
Administration of placebo will match that for lebrikizumab as either 1 or 2 injections. 
Participants may stay in the semi-recumbent position for 2 hours following study drug 
administration, where possible. 
6.2. 
Preparation, Handling, Storage, and Accountability  
The investigator or designee must confirm appropriate storage conditions have been maintained 
during transit for all study intervention received and any discrepancies are reported and resolved 
before use of the study intervention. 
Only participants enrolled in the study may receive study intervention. Only authorized study 
personnel may supply, prepare, or administer study intervention.  
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All study intervention must be stored in a secure, environmentally controlled, and monitored, 
manual or automated, area in accordance with the labeled storage conditions with access limited 
to the investigator and authorized study personnel. 
The investigator or authorized study personnel are responsible for study intervention 
accountability, reconciliation, and record maintenance, that is, receipt, reconciliation, and final 
disposition records. 
Further guidance and information for the final disposition of unused study interventions are 
provided in the pharmacy manual.  
Note: In some cases, sites may destroy the material if, during the investigative site selection, the 
evaluator has verified and documented that the site has appropriate facilities and written 
procedures to dispose of clinical materials. 
6.3. 
Assignment to Study Intervention  
On Day 1, participants will be assigned a unique randomization number in ascending numerical 
order. The randomization number will indicate the participant’s assignment to lebrikizumab or 
placebo, according to the randomization schedule generated prior to the study by the statistics 
department at the sponsor or its designee. Due to effect of body weight on PK, enrolment of 
participants with similar body weights between the cohorts is preferred. Each participant will be 
dispensed blinded study intervention, labeled with the participant’s unique randomization 
number. 
6.4. 
Blinding  
This is a participant- and investigator-blind study. The sponsor will not be blinded to treatment 
assignment; however, to preserve the blinding of the study, a minimum number of Lilly 
personnel and staff at the CRU, namely, CRU pharmacy staff, will see the randomization table 
before the study is complete. Individuals involved in the blinding of the study intervention will 
not be involved in any of the clinical aspects of the study, including study intervention 
administration and AE assessments. 
Participants will be randomly assigned in a 5:1 ratio to receive lebrikizumab and placebo. All 
study site personnel, except staff who prepare or dispense study medication, will remain blinded 
to each participant’s assigned study intervention throughout the course of the study.  
To maintain this blind, an otherwise uninvolved third party, unblinded site or CRU pharmacy 
staff, will be responsible for the removal of the tear-off portion of the label and dispensation of 
all study intervention and will endeavor to ensure that there are no differences in time taken to 
dispense following randomization.  
In the event of a quality assurance audit, the auditor will be allowed access to unblinded study 
intervention records at the site to verify that randomization or dispensing has been done 
accurately.  
Emergency codes will be available to the investigator. A code, which reveals the study 
intervention for a specific study participant, may be opened during the study only if the 
participant’s well-being requires knowledge of the participant’s treatment assignment. 
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In case of an emergency, the investigator has the sole responsibility for determining if unblinding 
of a participant’s treatment assignment is warranted for medical management of the event. The 
participant’s safety must always be the first consideration in making such a determination. 
Where feasible and when timing of the emergent situation permits, the investigator should 
attempt to contact the Lilly medical monitor before unblinding a participant’s treatment 
assignment. 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. 
Upon completion of the study, all codes must be returned to Lilly or its designee. 
If an investigator, site personnel performing assessments, or participant is unblinded, the 
participant must be discontinued from the study. In cases where there are ethical reasons to have 
the participant remain in the study, the investigator must obtain specific approval from a sponsor 
clinical research physician or clinical pharmacologist for the participant to continue in the study. 
6.5. 
Study Intervention Compliance  
Study intervention will be administered under medical supervision by the investigator or 
designee. The dose of study intervention and study participant identification will be confirmed 
prior to the time of dosing. The date and time of each dose administered will be recorded in the 
source documents and will be provided to the sponsor as requested.   
6.6. 
Dose Modification  
Dose adjustments are not permitted in this study.  
6.7. 
Continued Access to Study Intervention after the End of the Study  
Study intervention will not be made available after conclusion of the study to participants. 
6.8. 
Treatment of Overdose  
For this study, any dose of study intervention greater than the dose of study intervention assigned 
through randomization will be considered an overdose. 
The sponsor does not recommend specific treatment for an overdose. 
In the event of an overdose, the investigator should 
 contact the medical monitor immediately 
 evaluate the participant to determine, in consultation with the medical monitor, whether 
study intervention should be interrupted or whether the dose should be reduced 
 closely monitor the participant for any AE or SAE and laboratory abnormalities as 
medically appropriate, and 
 obtain a blood sample for PK analysis if requested by the medical monitor, determined on 
a case-by-case basis. 
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6.9. 
Prior and Concomitant Therapy  
Any medication or vaccine, including over-the-counter or prescription medicines, vitamins, or 
herbal supplements, or other specific categories of interest that the participant is receiving at the 
time of enrollment or receives during the study must be recorded along with the 
 reason for use 
 dates of administration including start and end dates, and 
 dosage information including dose and frequency for concomitant therapy of special 
interest. 
The medical monitor should be contacted if there are any questions regarding concomitant or 
prior therapy. 
Participants must abstain from taking over-the-counter, prescription medication including herbal 
medications and traditional Chinese medicines within 7 days, or 14 days if the drug is a potential 
enzyme inducer, or 5 half-lives, whichever is longer, prior to dosing and throughout the study. In 
addition, prior to dosing, the participant must also abstain from taking  
 biologic agents, such as monoclonal antibodies, including marketed drugs, within 
3 months or 5 half-lives, whichever is longer, and 
 live vaccines, including attenuated live vaccines, within 12 weeks prior to screening. 
Stable doses of hormone contraceptives, hormone-replacement therapy or thyroid replacement 
are permitted, at the discretion of the investigator. Supplements, for example vitamin 
supplements, may be permitted at the discretion of the investigator. 
Acetaminophen, at doses of less than or equal to 2 grams/day, is permitted for use any time 
during the study. Other concomitant medication may be considered on a case-by-case basis by 
the investigator in consultation with the medical monitor, if required. 
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7. 
Discontinuation of Study Intervention and Participant 
Discontinuation/Withdrawal  
Discontinuation of specific sites or of the study as a whole are handled as part of Section 10. 
7.1. 
Discontinuation of Study Intervention  
Not applicable.  
7.2. 
Participant Discontinuation/Withdrawal from the Study  
Discontinuation is expected to be uncommon. 
A participant may withdraw from the study 
 at any time at the participant’s own request for any reason or without providing any 
reason 
 at the request of the participant’s designee, for example, parents or legal guardian 
 at the discretion of the investigator for safety, behavioral, compliance, or administrative 
reasons, or 
 if enrolled in any other clinical study involving an investigational product, or enrolled in 
any other type of medical research judged not to be scientifically or medically compatible 
with this study. 
At the time of discontinuing from the study, if possible, the participant will complete procedures 
for an early discontinuation visit, as shown in the SoA in Section 1.3.  
If the participant withdraws consent for disclosure of future information, the sponsor may retain 
and continue to use any data collected before such a withdrawal of consent. If a participant 
withdraws from the study, the participant may request destruction of any samples taken and not 
tested, and the investigator must document this in the site study records. 
7.3. 
Lost to Follow-up  
A participant will be considered lost to follow-up if they repeatedly fail to return for scheduled 
visits and are unable to be contacted by the study site. Site personnel or designee are expected to 
make diligent attempts to contact participants who fail to return for a scheduled visit or were 
otherwise unable to be followed up by the site.  
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8. 
Study Assessments and Procedures  
Study procedures and their timing are summarized in the SoA in Section 1.3.  
The specifications in this protocol for the timings of safety and sample collection are given as 
targets to be achieved within reasonable limits. Modifications may be made to the time points 
based upon emerging clinical information. The scheduled time points may be subject to minor 
alterations; however, the actual time must be correctly recorded in the CRF. 
Immediate safety concerns should be discussed with the sponsor immediately upon occurrence or 
awareness to determine if the participant should continue or discontinue study intervention. 
Adherence to the study design requirements, including those specified in the SoA, is essential 
and required for study conduct. 
All screening evaluations must be completed and reviewed to confirm that potential participants 
meet all eligibility criteria. The investigator will maintain a screening log to record details of all 
participants screened and to confirm eligibility or record reasons for screening failure, as 
applicable.  
Section 10.2 lists the laboratory tests that will be performed for this study and Section 10.2.1 
provides a summary of the maximum number and volume of invasive samples, for all sampling, 
during the study. See Section 10.1.9 for details about sample retention and custody. 
8.1. 
Efficacy Assessments  
Efficacy is not evaluated in this study. 
8.2. 
Safety Assessments  
Planned time points for all safety assessments are provided in the SoA in Section 1.3. 
8.2.1. 
Physical Examinations  
A complete physical examination will include, at a minimum, assessments of the cardiovascular, 
respiratory, gastrointestinal, and neurological systems. Physical examinations will be conducted 
according to Section 1.3. 
Height and weight will also be measured and recorded. 
Investigators should pay special attention to clinical signs related to previous serious illnesses. 
8.2.2. 
Vital Signs  
For each participant, single vital sign measurements should be conducted according to 
Section 1.3. If warranted, additional vital signs may be measured. 
Blood pressure and pulse rate should be measured after at least 5 minutes sitting. When possible, 
measurements of blood pressure and pulse rate should be performed at approximately the same 
time of day at each scheduled time point. 
If orthostatic measurements are required, participants should be supine for at least 5 minutes and 
measurement obtained between 2 to 3 minutes after standing. 
If the participant feels unable to stand, supine vital signs only will be recorded. 
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Unscheduled orthostatic vital signs should be assessed, if possible, during any AE of dizziness or 
posture-induced symptoms. Additional vital signs may be measured throughout the study per 
investigator discretion. 
8.2.3. 
Electrocardiograms  
For each participant, a single 12-lead digital ECG will be collected according to Section 1.3. All 
single ECGs recorded should be stored at the investigational site. 
ECGs may be obtained at additional times when deemed clinically necessary, for example, to 
assess participants’ safety.  
ECGs must be recorded before collecting any blood samples. Participants must be supine for at 
least 5 minutes before ECG collection, and remain supine and awake during ECG collection.  
Any clinically significant findings from ECGs that result in a diagnosis and that occur after the 
participant receives the first dose of study intervention should be reported to the sponsor, or its 
designee, as an AE via the electronic CRF. 
ECGs will be interpreted by the investigator, a physician or qualified designee, at the site as soon 
after the time of ECG collection as practical, to determine whether the participant meets entry 
criteria.   
8.2.4. 
Clinical Safety Laboratory Assessments  
See Section 10.2 for the list of clinical safety laboratory assessments to be performed and the 
SoA in Section 1.3 for the timing and frequency. 
The investigator must review the laboratory results, document this review, and report any 
clinically relevant changes occurring during the study as an AE. The laboratory results must be 
retained with source documents unless a source document agreement or comparable document 
cites an electronic location that accommodates the expected retention duration. Clinically 
significant abnormal laboratory findings are those which are not associated with the underlying 
disease, unless judged by the investigator to be more severe than expected for the participant's 
condition. 
All laboratory tests with values considered clinically significantly abnormal during participation 
in the study should be repeated until the values return to normal or baseline or are no longer 
considered clinically significant by the investigator or medical monitor. 
If such values do not return to normal or baseline within a period of time judged reasonable by 
the investigator, the etiology should be identified, and the sponsor notified. 
All protocol-required laboratory assessments, as defined in Section 10.2, must be conducted in 
accordance with the SoA, standard collection requirements, and local laboratory procedures and 
requirements. 
If laboratory values from non-protocol specified laboratory assessments performed at an 
investigator-designated local laboratory require a change in participant management or are 
considered clinically significant by the investigator, for example, SAE or AE or dose 
modification, then report the information as an AE.  
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8.2.4.1. 
Tuberculosis Testing  
Participants will be tested, using either a QuantiFERON or T-spot test, and a chest x-ray 
conducted as indicated in the SoA in Section 1.3 for evidence of active or latent TB. If the test is 
indeterminate, one retest is allowed. If the retest is indeterminate, the participant will be 
excluded from the study. 
Participants who have had household contact with a person with active TB must be excluded 
unless appropriate and documented prophylaxis treatment for TB has been completed. 
Participants with any history of active TB are excluded from the study, regardless of previous or 
current TB treatments. 
8.2.5. 
Pregnancy Testing  
Pregnancy testing will be conducted according to Section 1.3. 
8.2.6. 
Safety Monitoring  
8.2.6.1. 
Hepatic Safety Monitoring, Evaluation, and Criteria for Study Drug 
Discontinuation  
This table summarizes actions to take based on abnormal hepatic laboratory or clinical changes. 
If this laboratory value is observed…  
Then…  
Initiate or continue close 
hepatic monitoring 
Initiate comprehensive 
evaluation 
ALT or AST greater than or equal to 3×ULN 
X 
 
ALP greater than or equal to 2×ULN  
X 
 
TBL greater than or equal to 2×ULNb 
X 
 
ALT or AST greater than or equal to 5×ULN 
X 
X 
ALP greater than or equal to 2.5×ULN 
X 
X 
ALT or AST greater than or equal to 3×ULN 
with hepatic signs or symptomsa  
X 
X 
ALT or AST greater than or equal to 5×ULN for 
more than 2 weeks  
X 
X 
ALT or AST greater than or equal to 8×ULN 
X 
X 
ALT or AST greater than or equal to 3×ULN and 
TBL greater than or equal to 2×ULNb 
X 
X 
ALP greater than or equal to 3×ULN  
X 
X 
ALP greater than or equal to 2.5×ULN and TBL 
greater than or equal to 2×ULNb 
X 
X 
ALP greater than or equal to 2.5×ULN with 
hepatic signs or symptomsa 
X 
X 
a Examples of hepatic signs or symptoms: severe fatigue, nausea, vomiting, right upper quadrant abdominal pain, 
fever, rash, or eosinophilia greater than 5%. 
b In participants with Gilbert’s syndrome, the threshold for TBL may be higher. 
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8.2.6.1.1. Close Hepatic Monitoring  
If a participant develops any one of these changes, initiate close hepatic monitoring: 
ALT or AST greater than or equal to 3×ULN or 
ALP greater than or equal to 2×ULN or 
TBL greater than or equal to 2×ULNa   
a In participants with Gilbert’s syndrome, the threshold for TBL may be higher. 
Close hepatic monitoring should include these actions: 
 Laboratory tests detailed in Section 10.5, including ALT, AST, ALP, TBL, direct 
bilirubin, complete blood count with differential, gamma-glutamyl transferase, and 
creatine kinase should be checked within 48 to 72 hours of the detection of elevated liver 
tests to confirm the abnormality and to determine if it is increasing or decreasing. 
 If the abnormality persists, clinical and laboratory monitoring should continue at a 
frequency of 2 to 3 times weekly until levels normalize or return to approximate baseline 
values.  
 In addition to laboratory tests, basic evaluation for possible causes of abnormal liver tests 
should be initiated by the investigator in consultation with the Lilly-designated medical 
monitor. At a minimum, this evaluation should include  
o physical examination and a thorough medical history, including current symptoms 
o recent illnesses, for example, heart failure, systemic infection, hypotension, or 
seizures 
o recent travel 
o concomitant medications including over-the-counter 
o herbal and dietary supplements 
o history of alcohol drinking, and 
o other substance abuse. 
8.2.6.1.2. Comprehensive Hepatic Evaluation  
If a participant develops any one of the following laboratory or clinical changes, initiate a 
comprehensive hepatic evaluation:  
ALT or AST greater than or equal to 5×ULN or 
ALP greater than or equal to 2.5×ULN or 
ALT or AST greater than or equal to 3×ULN with hepatic signs or symptomsa or 
ALT or AST greater than or equal to 5×ULN for more than 2 weeks or 
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ALT or AST greater than or equal to 8×ULN or 
ALT or AST greater than or equal to 3×ULN and TBL greater than or equal to 2×ULNb or 
INR greater than or equal to 1.5 
a Examples of hepatic signs or symptoms: severe fatigue, nausea, vomiting, right upper quadrant abdominal pain, 
fever, rash, or eosinophilia greater than 5%. 
b In participants with Gilbert’s syndrome, the threshold for TBL may be higher. 
Comprehensive hepatic evaluation should include these actions: 
 At a minimum, comprehensive hepatic evaluation should include physical examination 
and a thorough medical history, as outlined above, as well as tests for 
o prothrombin time-INR 
o viral hepatitis A, B, C, and E 
o autoimmune hepatitis, and 
o an abdominal imaging study, for example, ultrasound or computed tomography 
scan.  
 Based on the participant’s history and initial results, further testing should be considered 
in consultation with the Lilly-designated medical monitor, including tests for  
o hepatitis D virus  
o cytomegalovirus  
o Epstein-Barr virus  
o acetaminophen levels 
o urine toxicology screen 
o Wilson’s disease 
o blood alcohol levels 
o urinary ethyl glucuronide, and  
o blood phosphatidylethanol.  
 Based on the circumstances and the investigator’s assessment of the participant’s clinical 
condition, the investigator should consider referring the participant for a hepatologist or 
gastroenterologist consultation, and additional tests including  
o magnetic resonance cholangiopancreatography 
o endoscopic retrograde cholangiopancreatography 
o cardiac echocardiogram, or  
o a liver biopsy.   
 Clinical and laboratory monitoring should continue at a frequency of 1 to 2 times weekly 
until levels normalize or return to approximate baseline values.  
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All the medical information and test results related to the hepatic monitoring and comprehensive 
hepatic evaluation should be collected and recorded in a hepatic safety CRF. 
8.2.6.2. 
Injection Site Reactions  
Symptoms and signs of a local ISR may include erythema, induration, pain, pruritus, and edema. 
If an ISR is reported by a participant or site staff, it will be recorded as an AE of a local ISR, and 
the ISR CRF will be used to capture additional information about this reaction, for example, 
injection-site pain, degree and area of erythema, induration, pruritus, and edema. 
In addition, all positive responses of injection-site pain will require an additional assessment 
using the Pain Visual Analog Scale (Williamson and Hoggart, 2005). 
8.2.6.3. 
Hypersensitivity Reactions  
Many drugs, including oral agents and biologic agents, carry the risk of systemic hypersensitivity 
reactions. If such a reaction occurs, additional data should be provided to the sponsor in the 
designated CRFs. 
Sites should have appropriately trained medical staff and appropriate medical equipment 
available when study participants are receiving study intervention. It is recommended that 
participants who experience a systemic hypersensitivity reaction be treated per national and 
international guidelines. 
In the case of a suspected systemic hypersensitivity event, additional blood samples should be 
collected as described in Section 10.2.2. Laboratory results are provided to the sponsor via the 
central laboratory. 
8.3. 
Adverse Events, Serious Adverse Events, and Product Complaints  
The definitions of AEs, SAEs, and product complaints can be found in Section 10.3. 
These events will be reported by the participant, or, when appropriate, by a caregiver, surrogate, 
or the participant's legally authorized representative. 
The investigator and any qualified designees are responsible for detecting, documenting, and 
recording events that meet these definitions and remain responsible for following up events that 
are serious, considered related to the study intervention or study procedures, or that caused the 
participant to discontinue the study as described in Section 7. 
Care will be taken not to introduce bias when detecting events. Open-ended and non-leading 
verbal questioning of the participant is the preferred method to inquire about event occurrences. 
After the initial report, the investigator is required to proactively follow each participant at 
subsequent visits/contacts. All SAEs and AEs of special interest, as defined in Section 8.3.3, will 
be followed until resolution, stabilization, the event is otherwise explained, or the participant is 
lost to follow-up as defined in Section 7.3.  
For product complaints, the investigator is responsible for ensuring that follow-up includes any 
supplemental investigations as indicated to elucidate the nature or causality. Further information 
on follow-up procedures is provided in Section 10.3. 
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Investigators are responsible for monitoring the safety of participants who have entered this 
study and for alerting Lilly or its designee to any event that seems unusual, even if this event 
may be considered an unanticipated benefit to the participant.  
The investigator is responsible for the appropriate medical care of participants during the study. 
8.3.1. 
Timing and Mechanism for Collecting Events  
This table describes the timing, deadlines, and mechanism for collecting events. 
Event 
Collection 
Start 
Collection 
Stop 
Timing for 
Reporting to 
Sponsor or 
Designee 
Mechanism for 
Reporting 
Back-up 
Method of 
Reporting 
Adverse Event 
AE 
Signing of 
the ICF 
Participation 
in study has 
ended 
As soon as possible 
upon site awareness 
AE CRF 
N/A 
Serious Adverse Event 
SAE and SAE 
updates – prior to 
start of study 
intervention and 
deemed 
reasonably 
possibly related to 
study procedures 
Signing of 
the ICF 
Start of 
intervention 
Within 24 hours of 
awareness 
SAE paper form 
SAE paper 
form 
SAE and SAE 
updates – after 
start of study 
intervention 
Start of 
intervention 
Participation 
in study has 
ended 
Within 24 hours of 
awareness 
SAE paper form 
SAE paper 
form 
SAE* – after 
participant’s 
study 
participation has 
ended and the 
investigator 
becomes aware 
After 
participant’s 
study 
participation 
has ended 
N/A 
Promptly 
SAE paper form 
N/A 
Pregnancy 
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Event 
Collection 
Start 
Collection 
Stop 
Timing for 
Reporting to 
Sponsor or 
Designee 
Mechanism for 
Reporting 
Back-up 
Method of 
Reporting 
Pregnancy in 
female 
participants and 
female partners of 
male participants 
After the 
start of study 
intervention 
Participation 
in the study 
has ended.  
Within 24 hours 
(see Section 8.3.2) 
Pregnancy paper 
form  
Pregnancy 
paper form 
Product Complaints 
PC associated 
with an SAE or 
might have led to 
an SAE 
Start of 
study 
intervention 
End of study 
intervention 
Within 24 hours of 
awareness 
Product Complaint 
form 
N/A 
PC not associated 
with an SAE 
Start of 
study 
intervention 
End of study 
intervention 
Within 1 business 
day of awareness 
Product Complaint 
form 
N/A 
Updated PC 
information 
—  
—  
As soon as possible 
upon site awareness 
Originally completed 
Product Complaint 
form with all 
changes signed and 
dated by the 
investigator 
N/A 
PC (if investigator 
becomes aware) 
Participation 
in study has 
ended 
N/A 
Promptly 
Product Complaint 
form 
 
Abbreviations: AE = adverse event; CRF = case report form; ICF = informed consent form; PC = product 
complaint; N/A = not applicable; SAE = serious adverse event 
* SAEs should not be reported unless the investigator deems them to be possibly related to study treatment or study 
participation. 
8.3.2. 
Pregnancy  
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 learning of a pregnancy in the female partner of a study participant, the investigator  
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 will obtain a consent to release information from the pregnant female partner directly, 
and 
 within 24 hours after obtaining this consent will record pregnancy information on the 
appropriate form and submit it to the sponsor.  
The female partner will also be followed 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 regardless of gestational age, fetal status, presence or absence of 
anomalies, or 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 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, regardless of 
gestational age, 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.  
A spontaneous abortion, occurring at less than 20 weeks gestational age, or still birth, occurring 
at greater than or equal to 20 weeks gestational age, is always considered to be an SAE and will 
be reported as such.  
Any post-study pregnancy related SAE considered reasonably related to the study intervention 
by the investigator will be reported to the sponsor as described in protocol Section 8.3.1. While 
the investigator is not obligated to actively seek this information in former study participants, he 
or she may learn of an SAE through spontaneous reporting. 
8.3.3. 
Adverse Events of Special Interest  
Adverse events of special interest for this program include 
 conjunctivitis 
 keratitis 
 ISRs, and 
 hypersensitivity reactions. 
If these AEs of special interest are reported, sites will be prompted to collect additional details 
and data. 
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8.4. 
Pharmacokinetics  
Blood samples will be collected for measurement of serum concentrations of lebrikizumab as 
specified in the SoA in Section 1.3.  
Instructions for the collection and handling of biological samples will be provided by the 
sponsor. The actual date and 24-hour clock time of each sample will be recorded. 
Study intervention concentration information that may unblind the study will not be reported to 
investigative sites or blinded personnel until the study has been unblinded. 
8.4.1. 
Bioanalysis  
Samples will be analyzed at a laboratory approved by the sponsor and stored at a facility 
designated by the sponsor.  
Serum concentrations of lebrikizumab will be assayed 
 
. Analyses of samples collected from placebo-treated participants 
are not planned.  
8.5. 
Pharmacodynamics  
Pharmacodynamic parameters are not evaluated in this study. 
8.6. 
Genetics  
Genetics are not evaluated in this study. 
8.7. 
Biomarkers  
Biomarkers are not evaluated in this study. 
8.8. 
Immunogenicity Assessments  
Antibodies to lebrikizumab will be evaluated in blood samples collected from all participants 
according to the SoA in Section 1.3. Antibodies may be further characterized and/or evaluated 
for their ability to neutralize the activity of lebrikizumab. To interpret the results of 
immunogenicity, a venous blood sample will be collected at the same time points to determine 
the serum concentrations of lebrikizumab. All samples for immunogenicity should be taken 
predose when applicable and possible.  
TE ADA are defined in Section 9.3.4. 
Immunogenicity will be assessed by
 
 Antidrug antibody samples will be stored 
as per local regulation or IRB/IEC requirements. Samples will be immediately destroyed once 
lebrikizumab is launched or there is no further request on testing the samples from China 
authority. 
8.9. 
Health Economics  
This section is not applicable for this study. 
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9. 
Statistical Considerations  
The SAP will be finalized prior to first participant first visit, and it will include a more technical 
and detailed description of the statistical analyses described in this section. This section is a 
summary of the planned statistical analyses of the most important endpoints, including primary 
and key secondary endpoints. 
9.1. 
Statistical Hypothesis  
The primary objective of this study is to describe the safety of a single dose of 250 mg and 
500 mg lebrikizumab in healthy Chinese participants. There will be no formal hypothesis testing.  
9.2. 
Analyses Sets  
The following populations are defined: 
Population 
Description 
Entered 
All participants who sign the ICF. 
Enrolled 
All participants who were assigned to study intervention, 
regardless of whether they take any doses. Participants will be 
analyzed according to the treatment group to which they have 
been assigned. 
Safety analysis 
All participants randomly assigned to study intervention and who 
receive study intervention. Participants will be analyzed 
according to the intervention they actually received. 
Immunogenicity analysis 
Same as safety population. 
Pharmacokinetic analysis 
All enrolled participants who receive a full dose of lebrikizumab 
and have evaluable PK data. 
9.3. 
Statistical Analyses  
9.3.1. 
General Considerations  
Statistical analysis of this study will be the responsibility of the sponsor or its designee.  
PK analyses will be conducted on data from all enrolled participants who receive a full dose of 
lebrikizumab and have evaluable PK data. 
Safety and immunogenicity analyses will be conducted for all enrolled participants who receive 
study intervention, whether or not they completed all protocol requirements.  
Summary statistics, data tabulations, and data graphs will be provided as deemed appropriate. 
Additional exploratory analyses of the data will be conducted as appropriate. Details of analyses 
will be provided in the SAP. Study results may be pooled with the results of other studies for 
safety and population PK analysis purposes to avoid issues with post-hoc analyses and 
incomplete disclosures of analyses.  
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Handling of missing, unused, and spurious data is addressed prospectively in the overall 
statistical methods described in the protocol and in the SAP, where appropriate. Adjustments to 
the planned analyses will be described in the final clinical study report. 
9.3.2. 
Safety Analysis  
The primary endpoint is the incidence of TEAEs and SAEs to investigate the safety of 
lebrikizumab versus placebo following SC administration of a single dose in Chinese healthy 
participants.  
Safety data will be listed and summarized by treatment group. 
All AEs will be listed, and if the frequency of events allows, safety data will be summarized 
using descriptive methodology. 
Other safety parameters that will be assessed include safety laboratory parameters and vital 
signs. Safety parameters will be listed and summarized using standard descriptive statistics as 
appropriate.  
The incidence of AEs for each treatment will be presented by severity and by association with 
the study intervention as perceived by the investigator. AEs reported to have occurred prior to 
randomization will be distinguished from those reported as new or increased in severity during 
the study. Each AE will be classified by the most suitable term from the Medical Dictionary for 
Regulatory Activities. 
The number of TEAEs and SAEs will be reported. 
9.3.3. 
Pharmacokinetic Analysis  
Noncompartmental analysis will be conducted, and PK parameters such as maximum observed 
drug concentration, time to maximum observed drug concentration, area under the concentration 
versus time curve from time zero to infinity, and area under the concentration versus time curve 
from time zero to t, where t is the last time point with a measurable concentration will be 
reported for lebrikizumab. Other noncompartmental parameters such as apparent clearance, 
apparent volume of distribution, and half-life may be reported, as appropriate. 
Exploratory graphical analyses relating lebrikizumab serum exposure and immunogenicity may 
be conducted. 
9.3.4. 
Immunogenicity Analysis  
The frequency and percentage of participants with pre-existing ADA and with TE ADA to 
lebrikizumab may be tabulated by treatment. TE ADA are defined as those with a titer 2-fold, 
1 dilution, greater than the minimum required dilution if no ADA were detected at baseline, 
treatment-induced ADA, or those with a 4-fold, 2 dilutions, increase in titer compared to baseline 
if ADA were detected at baseline, treatment-boosted ADA. 
The frequency of neutralizing antibodies and distribution of maximum titers may also be 
tabulated in TE ADA+ participants by treatment. 
The relationship between the presence of antibodies to lebrikizumab and safety may be assessed. 
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9.4. 
Interim Analysis  
No interim analyses are planned for this study. If an unplanned interim analysis is deemed 
necessary for reasons other than a safety concern, the protocol must be amended. 
Unblinding details are specified in the unblinding plan section of the SAP or in a separate 
unblinding plan document. 
9.5. 
Sample Size Determination  
Approximately 24 participants will be enrolled in 2 dosing cohorts for at least 20 evaluable 
participants to complete the study. The sample sizes described are customary for Phase 1 studies 
evaluating safety and PK parameters and are not powered on the basis of statistical hypothesis 
testing. Each cohort will comprise approximately 12 participants with a randomization ratio of 
5:1 between lebrikizumab and placebo. Participants who discontinue the study before completing 
may be replaced at the discretion of the sponsor and investigator. The replacement participant 
can complete the entire study period. 
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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 CIOMS International Ethical Guidelines 
 Applicable ICH GCP Guidelines, and 
 Applicable laws and regulations. 
The protocol, protocol amendments, ICF, IB, and other relevant documents, for example, 
advertisements, must be submitted to an IRB/IEC by the investigator and reviewed and approved 
by the IRB/IEC before the study is initiated. 
Any amendments to the protocol will require IRB/IEC approval before implementation of 
changes made to the study design, except for changes necessary to eliminate an immediate 
hazard to study participants. 
Protocols and any substantial amendments to the protocol will require health authority approval 
prior to initiation 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 
 providing oversight of study conduct for participants under their responsibility and 
adherence to requirements of 21 CFR, ICH guidelines, the IRB/IEC, European regulation 
536/2014 for clinical studies, if applicable, and all other applicable local regulations, and 
 reporting to the sponsor or designee significant issues related to participant safety, 
participant rights, or data integrity. 
Investigator sites are compensated for participation in the study as detailed in the clinical trial 
agreement. 
10.1.2. 
Informed Consent Process  
The investigator or the investigator’s representative will explain the nature of the study, 
including the risks and benefits, to the potential participant and answer all questions regarding 
the study. 
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Potential participants must be informed that their participation is voluntary. Participants will be 
required to sign a statement of informed consent that meets the requirements of 21 CFR 50, local 
regulations, ICH guidelines, privacy, and data protection requirements, where applicable, and the 
IRB/IEC or study center. 
The medical record must include a statement that written informed consent was obtained before 
the participant was entered in the study and the date the written consent was obtained. The 
authorized person obtaining the informed consent must also sign the ICF. 
Revised consents must be appropriately obtained using the correct approved ICFs for applicable 
study participants in accordance with sponsor and IRB/IEC consenting guidance. 
A copy of the ICF must be provided to the participant and is kept on file. 
10.1.3. 
Data Protection  
Participants will be assigned a unique identifier by the sponsor to protect the participant’s 
personal data. Any participant information, such as records, datasets or tissue samples, that are 
transferred to the sponsor will contain the identifier only. Participant names or any information 
which would make the participant identifiable will not be transferred. 
The participant must be informed that the participant’s 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. This is done by the site personnel through the informed 
consent process. 
The participant must be informed through the informed consent by the site personnel 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 information security, data integrity, and data 
protection. These processes address management of data transfer, and prevention and 
management of unauthorized access, disclosure, dissemination, alteration or loss of information 
or personal data. These processes include appropriate contingency plans for appropriate and 
timely response in the event of a data security breach. 
The transfer of personal data is subject to appropriate safeguards through contractual agreements 
and processes. The sponsor’s processes are compliant with local privacy laws and relevant 
legislations including the General Data Protection Regulation. 
10.1.4. 
Dissemination of Clinical Study Data  
Communication of Suspended or Terminated Dosing 
If a decision is taken to suspend or terminate dosing in the study due to safety findings, this 
decision will be communicated by Lilly to all investigators, for example, by phone or email, as 
soon as possible. It will be a requirement that investigators respond upon receipt to confirm that 
they understand the communication and have taken the appropriate action prior to further dosing 
any participants with study intervention. Any investigator not responding will be followed up by 
Lilly personnel prior to any further planned dosing. If a dose is planned imminently, Lilly 
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personnel will immediately, and continually, use all efforts to reach investigators until contact is 
made and instructions verified. 
Reports 
The sponsor will disclose a summary of study information, including tabular study results, on 
publicly available websites where required by local law or regulation. 
The summary of results will be posted within the time frame specified by local law or regulation. 
If the study remains ongoing in some countries and a statistical analysis of an incomplete dataset 
would result in analyses lacking scientific rigor, for example, underpowered, or compromise the 
integrity of the overall analyses, for example, trial not yet unblinded, the summary of results will 
be submitted within 1 year after the end of the study globally or as soon as available, whichever 
is earlier. 
Data 
The sponsor does not proactively share data from Phase 1 clinical trials. Requests for access to 
Phase 1 clinical trial data are evaluated on a case by case basis taking into consideration the 
ability to anonymize the data and the nature of the data collected. 
10.1.5. 
Data Quality Assurance  
All participant data relating to the study will be recorded on printed or electronic CRFs unless 
transmitted to the sponsor or designee electronically, for example, laboratory data. The 
investigator is responsible for verifying that data entries are accurate and correct by physically or 
electronically signing the CRF. 
The investigator must maintain accurate documentation, source data, that supports the 
information entered in the CRF. This includes laboratory tests, medical records, and clinical 
notes. 
The investigator must review and confirm that data entries are accurate and complete throughout 
the duration of the study, by physically or electronically signing the CRF, as instructed by the 
sponsor. All completed CRFs must be signed prior to archival. 
The investigator must permit study-related monitoring, audits, IRB/IEC review, and regulatory 
agency inspections and provide direct access to source documents. 
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 and requirements, including handling of noncompliance issues and 
monitoring techniques are provided in the Monitoring Plan. 
The sponsor or designee is responsible for the data management of this study including quality 
checking of the data. 
The sponsor assumes accountability for actions delegated to other individuals, for example, 
contract research organizations. 
The sponsor or designee will perform monitoring to confirm that data transcribed into the CRF 
by authorized site personnel are accurate, complete, and verifiable from source documents; that 
the safety and rights of participants are being protected; and that the study is being conducted in 
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accordance with the currently approved protocol and any other study agreements, ICH GCP, and 
all applicable regulatory requirements. 
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. 
In addition, 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, or 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 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 electronic data capture 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 system will be stored at a third-party. The 
investigator will have continuous access to the data during the study and until decommissioning 
of the data capture system. Prior to decommissioning, the investigator will receive or access an 
archival copy of pertinent data for retention. 
Data managed by a central vendor, such as laboratory test data, will be stored electronically in 
the central vendor’s database system and reports or electronic transfers will be provided to the 
investigator for review and retention. Data will subsequently be transferred from the central 
vendor to the sponsor data warehouse. 
Data from complaint forms submitted to the sponsor will be encoded and stored in the global 
product complaint management system. 
10.1.6. 
Source Documents  
Source documents provide evidence for the existence of the participant and substantiate the 
integrity of the data collected. Source documents are filed at the investigator’s site. 
Data that are reported on or entered in the CRF and are transcribed from source documents must 
be consistent with the source documents or the discrepancies must be explained. The investigator 
may need to request previous medical records or transfer records, depending on the study. Also, 
current medical records must be available. 
Definition of what constitutes source data can be found in the site confirmation of source data. 
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10.1.7. 
Study and Site Start and Closure  
First Act of Recruitment 
The study start date is the date on which the clinical study will be open for recruitment of 
participants. 
Study or Site Termination 
The sponsor or sponsor’s designee reserves the right to close the study site or terminate the study 
at any time for any reason at the sole discretion of the sponsor. Study sites will be closed upon 
study completion. A study site is considered closed when all required documents and study 
supplies have been collected and a study-site closure visit has been performed. 
The investigator may initiate study-site closure at any time, provided there is reasonable cause 
and sufficient notice is given in advance of the intended termination. 
Reasons for the early closure of a study site by the sponsor or investigator may include but are 
not limited to 
 for study termination due to discontinuation of further study intervention development 
 for site termination due to 
o failure of the investigator to comply with the protocol, the requirements of the 
IRB/IEC or local health authorities, the sponsor's procedures, or GCP guidelines 
o inadequate recruitment, evaluated after a reasonable amount of time, of 
participants by the investigator, or 
o total number of participants included earlier than expected. 
If the study is prematurely terminated or suspended, the sponsor shall promptly inform the 
investigators, the IECs/IRBs, the regulatory authorities, and any contract research organization 
used in the study of the reason for termination or suspension, as specified by the applicable 
regulatory requirements. The investigator shall promptly inform the participant and should assure 
appropriate participant therapy and/or follow-up. 
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. 
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10.1.9. 
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 lebrikizumab or after lebrikizumab becomes commercially available. 
Sample Type 
Custodian 
Retention Period After Last 
Participant Visit 
Pharmacokinetic 
Sponsor or designee 
1 year 
Immunogenicity  
Sponsor or designee Per local regulation or the IECs/IRBs 
requirements. Samples will be 
immediately destroyed once 
lebrikizumab is launched or there is 
no further request on testing the 
samples from China authority. 
Hematology, chemistry, 
urinalysis, and hepatic 
monitoring (both central and 
local laboratory) 
Sponsor or designee 
These samples are destroyed after 
protocol-specific tests are performed, 
based on the requirements for the 
laboratory procedures, laws, 
regulations, or internal laboratory 
certification standard.  
 
 
 
 
 
 
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10.2. 
Appendix 2: Clinical Laboratory Tests  
The tests detailed in the table below will be performed by the laboratories listed in Section 10.7. 
In circumstances where the sponsor approves local laboratory testing in lieu of central laboratory 
testing, in the table below, the local laboratory must be qualified in accordance with applicable 
local regulations. 
Protocol-specific requirements for inclusion or exclusion of participants are detailed in Section 5 
of the protocol. 
Additional tests may be performed at any time during the study as determined necessary by the 
investigator or required by local regulations. 
Investigators must document their review of the laboratory safety results. 
Laboratory or analyte results that could unblind the study will not be reported to investigative 
sites or other blinded personnel until the study has been unblinded. 
 
 
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Clinical Laboratory Tests  
Comments 
Hematology 
Hematocrit 
Cell morphology (RBC and WBC) 
Hemoglobin 
Differential counts (% and absolute) 
of:  
Erythrocyte count (RBC) 
Neutrophils 
Mean cell volume  
Lymphocytes 
Mean cell hemoglobin  
Monocytes 
Mean cell hemoglobin concentration  
Eosinophils 
Leukocytes (WBC)  
Basophils 
Platelets 
Clinical Chemistry 
Sodium 
Total cholesterol  
Potassium 
Total protein 
Chloride 
Albumin 
Calcium  
Total bilirubin  
Phosphorus 
Direct bilirubin 
Glucose 
Alkaline phosphatase  
Blood urea nitrogen or urea 
Aspartate aminotransferase  
Creatinine 
Alanine aminotransferase  
Uric acid 
Gamma-glutamyl transferase  
Urinalysis 
Specific gravity 
Urobilinogen 
pH 
Blood 
Protein 
Nitrite 
Glucose 
Microscopic examination of 
sediment 
Ketones 
Bilirubin 
Other Tests 
Ethanol testing 
Urine drug screen 
Tests may be repeated locally at 
additional time points at the discretion of 
the investigator. 
QuantiFERON®-TB Gold or T-
SPOT® 
Urine and serum pregnancy test 
(women of childbearing potential 
only) 
FSH (females only) 
Serology 
Hepatitis B surface antigen 
HIV 
Hepatitis B core antibody 
Hepatitis C antibody 
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Pharmacokinetic Samples  
Results will not be provided to the 
investigative sites.  
Lebrikizumab concentration  
Immunogenicity (ADA) Samples 
Results will not be provided to the 
investigative sites.  
Anti-LY3650150 antibodies   Anti-LY3650150 antibodies 
neutralization   
Abbreviations: ADA = anti-drug antibody; FSH = follicle-stimulating hormone; HIV = human immunodeficiency 
virus; RBC = red blood cell; TB = tuberculosis; WBC = white blood cell. 
10.2.1. 
Blood Sampling Summary  
This table summarizes the approximate number of venipunctures and blood volumes for all 
blood sampling, screening, safety laboratories, and bioanalytical assays during the study.   
 
Purpose 
Blood Volume per 
Sample (mL) 
Number of Blood 
Samples 
Total Volume 
(mL) 
Screening testsa 
18.5 
1 
18.5 
Hematology and chemistrya 
5.5 
11 
60.5 
Pharmacokinetics  
3 
13 
39 
Immunogenicity 
10 
5 
50 
Total 
 
 
168 
Total for clinical purposes  
170 
a Additional samples may be drawn if needed for safety purposes. 
10.2.2. 
Laboratory Samples to be Obtained at the Time of a Systemic Hypersensitivity 
Event  
Purpose of collecting samples after a systemic hypersensitivity event 
The samples listed in this appendix are not collected for acute study participant management. 
The sponsor will use the laboratory test results from these samples to characterize 
hypersensitivity events across the clinical development program. 
When to collect samples after a systemic hypersensitivity event occurs 
Collect the samples listed below if a systemic hypersensitivity event is suspected. The timing 
should be as designated in the table, assuming the participant has been stabilized. 
Obtain follow-up predose samples at the next regularly scheduled laboratory sample collection, 
ideally prior to the next dose after the event, to assess post-event return-to-baseline values. 
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Timing 
Laboratory Test a 
Collect from 30 minutes to 4 hours after the start of 
the event.  
Note: The optimal collection time is from 1 to 
2 hours after the start of event. 
total tryptase 
complements (C3, C3a, and C5a)  
cytokine panel (IL-6, IL‐1β, IL‐10 or any cytokine 
panel that includes these 3 cytokines)  
Collect only if not already collected on the same day as 
the event. 
Note: If collecting, collect up to 12 hours after the 
start of the event. 
LY3650150 anti-drug antibodies  
LY3650150 concentration 
a All samples for hypersensitivity testing will be assayed by Lilly-designated laboratory. Results will not be 
provided to the study site. If samples are not collected or are collected outside the specified time period, this will 
not be considered a protocol deviation. 
Abbreviations: ADA = anti-drug antibodies; IL = interleukin. 
What information to record 
Record the date and time when the samples are collected. 
Allowed additional testing for participant management 
The investigator may perform additional tests locally, if clinically indicated, for acute study 
participant management. 
 
 
 
 
 
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10.3. 
Appendix 3: Adverse Events and Serious Adverse Events: Definitions 
and Procedures for Recording, Evaluating, Follow-up, and 
Reporting  
10.3.1. 
Definition of AE  
 An AE is any untoward medical occurrence in a participant administered a 
pharmaceutical product and which does not necessarily have a causal relationship with 
the study intervention. An AE can therefore be any unfavorable and unintended sign, 
including an abnormal laboratory finding, symptom, or disease, new or exacerbated, 
temporally associated with the use of a medicinal investigational product, or 
investigational combination product, whether or not related to the medicinal 
investigational product or investigational combination product. 
Events meeting the AE definition 
 Any abnormal laboratory test results, hematology, clinical chemistry, or urinalysis, or 
other safety assessments, for example, ECG, radiological scans, and vital signs 
measurements, including those that worsen from baseline, considered clinically 
significant in the medical and scientific judgment of the investigator, that is, not related to 
progression of underlying disease. 
 Exacerbation of a chronic or intermittent pre-existing condition including either an 
increase in frequency and/or intensity of the condition. 
 New condition detected or diagnosed after study intervention administration even though 
it may have been present before the start of the study. 
 Signs, symptoms, or the clinical sequelae of a suspected drug-drug interaction. 
 Medication error, misuse, or abuse of investigational medicinal product, including signs, 
symptoms, or clinical sequelae. 
Events NOT meeting the AE definition 
 Any clinically significant abnormal laboratory findings or other abnormal safety 
assessments that are associated with the underlying disease, unless judged by the 
investigator to be more severe than expected for the participant’s condition. 
 The disease or disorder being studied or expected progression, signs, or symptoms of the 
disease or disorder being studied, unless more severe than expected for the participant’s 
condition. 
 Medical or surgical procedure, for example, endoscopy, appendectomy. The condition 
that leads to the procedure is the AE. 
 Situations in which an untoward medical occurrence did not occur, social or convenience 
admission to a hospital. 
 Anticipated day-to-day fluctuations of pre-existing diseases or conditions present or 
detected at the start of the study that do not worsen.  
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10.3.2. 
Definition of SAE  
An SAE is defined as any untoward medical occurrence that, at any dose, meets one or 
more of the criteria listed: 
 Results in death 
 Is life-threatening 
o The term life-threatening in the definition of serious refers to an event in which 
the participant was at risk of death at the time of the event. It does not refer to an 
event which hypothetically might have caused death if it were more severe. 
 Requires inpatient hospitalization or prolongation of existing hospitalization 
o In general, hospitalization signifies that the participant has been admitted to 
hospital or emergency ward, usually involving at least an overnight stay, for 
observation and/or treatment that would not have been appropriate in the 
physician’s office or outpatient setting. Complications that occur during 
hospitalization are AEs. If a complication prolongs hospitalization or fulfills any 
other serious criteria, the event is serious. When in doubt as to whether 
hospitalization occurred or was necessary, the AE should be considered serious. 
o Hospitalization for elective treatment of a pre-existing condition that did not 
worsen from baseline is not considered an AE. 
 Results in persistent disability/incapacity 
o The term disability means a substantial disruption of a person’s ability to conduct 
normal life functions. 
o This definition is not intended to include experiences of relatively minor medical 
significance, such as uncomplicated headache, nausea, vomiting, diarrhea, 
influenza, and accidental trauma, for example, sprained ankle, which may 
interfere with or prevent everyday life functions but do not constitute a substantial 
disruption. 
 Is a congenital anomaly/birth defect 
o Abnormal pregnancy outcomes, for example, spontaneous abortion, fetal death, 
stillbirth, congenital anomalies, and ectopic pregnancy, are considered SAEs. 
 Other situations: 
o Medical or scientific judgment should be exercised by the investigator in deciding 
whether SAE reporting is appropriate in other situations such as important 
medical events that may not be immediately life-threatening or result in death or 
hospitalization but may jeopardize the participant or may require medical or 
surgical intervention to prevent one of the other outcomes listed in the above 
definition. These events should usually be considered serious. 
o Examples of such events include invasive or malignant cancers, intensive 
treatment in an emergency room or at home for allergic bronchospasm, blood 
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dyscrasias or convulsions that do not result in hospitalization, or development of 
drug dependency or drug abuse. 
10.3.3. 
Definition of Product Complaints  
Product complaint 
A product complaint is any written, electronic, or oral communication that alleges deficiencies 
related to the identity, quality, durability, reliability, safety, effectiveness, or performance of a 
study intervention. When the ability to use the study intervention safely is impacted, the 
following are also product complaints: 
 deficiencies in labeling information, and 
 use errors for device or drug-device combination products due to ergonomic design 
elements of the product. 
Product complaints related to study interventions used in clinical trials are collected to ensure the 
safety of participants, monitor quality, and to facilitate process and product improvements. 
Investigators will instruct participants to contact the site as soon as possible if he or she has a 
product complaint or problem with the study intervention so that the situation can be assessed. 
An event may meet the definition of both a product complaint and an AE/SAE. In such cases, it 
should be reported as both a product complaint and as an AE/SAE. 
10.3.4. 
Recording and Follow-Up of AE and/or SAE and Product Complaints  
AE, SAE, and product complaint recording 
When an AE/SAE/product complaint occurs, it is the responsibility of the investigator to review 
all documentation, for example, hospital progress notes, laboratory reports, and diagnostics 
reports, related to the event. 
The investigator will then record all relevant AE/SAE/product complaint information in the 
participant’s medical records, in accordance with the investigator’s normal clinical practice. 
AE/SAE information is reported on the appropriate CRF page and product complaint information 
is reported on the Product Complaint Form. 
Note: An event may meet the definition of both a product complaint and an AE/SAE. In such 
cases, it should be reported as both a product complaint and as an AE/SAE. 
It is not acceptable for the investigator to send photocopies of the participant’s medical records 
to the sponsor or designee in lieu of completion of the CRF page for AE/SAE and the Product 
Complaint Form for product complaints. 
There may be instances when copies of medical records for certain cases are requested by the 
sponsor or designee. In this case, all participant identifiers, with the exception of the participant 
number, will be redacted on the copies of the medical records before submission to the sponsor 
or designee. 
The investigator will attempt to establish a diagnosis of the event based on signs, symptoms, 
and/or other clinical information. Whenever possible, the diagnosis, not the individual 
signs/symptoms, will be documented as the AE/SAE.  
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Assessment of intensity 
The investigator will make an assessment of intensity for each AE and SAE reported during the 
study and assign it to one of the following categories:  
 Mild: A type of AE that is usually transient and may require only minimal treatment or 
therapeutic intervention. The event does not generally interfere with usual activities of 
daily living. 
 Moderate: A type of AE that is usually alleviated with additional specific therapeutic 
intervention. The event interferes with usual activities of daily living, causing discomfort 
but poses no significant or permanent risk of harm to the research participant. 
 Severe: A type of AE that interrupts usual activities of daily living, or significantly 
affects clinical status, or may require intensive therapeutic intervention. An AE that is 
assessed as severe should not be confused with an SAE. Severe is a category utilized for 
rating the intensity of an event, and both AEs and SAEs can be assessed as severe. 
An event is defined as “serious” when it meets at least one of the predefined outcomes as 
described in the definition of an SAE, NOT when it is rated as severe.  
Assessment of causality 
The investigator is obligated to assess the relationship between study intervention and each 
occurrence of each AE/SAE. The investigator will use clinical judgment to determine the 
relationship. 
A “reasonable possibility” of a relationship conveys that there are facts, evidence, and/or 
arguments to suggest a causal relationship, rather than a relationship cannot be ruled out. 
Alternative causes, such as underlying diseases, concomitant therapy, and other risk factors, as 
well as the temporal relationship of the event to study intervention administration will be 
considered and investigated. 
The investigator will also consult the IB in their assessment. 
The investigator must review and provide an assessment of causality for each AE/SAE and 
document this in the medical notes. 
There may be situations in which an SAE has occurred and the investigator has minimal 
information to include in the initial report to the sponsor or designee. However, it is very 
important that the investigator always make an assessment of causality for every event before the 
initial transmission of the SAE data to the sponsor or designee. 
The investigator may change their opinion of causality in light of follow-up information and send 
an SAE follow-up report with the updated causality assessment. 
The causality assessment is one of the criteria used when determining regulatory reporting 
requirements. 
Follow-up of AEs and SAEs 
 The investigator is obligated to perform or arrange for the conduct of supplemental 
measurements and/or evaluations as medically indicated or as requested by the sponsor or 
designee to elucidate the nature and/or causality of the AE or SAE as fully as possible. 
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This may include additional laboratory tests or investigations, histopathological 
examinations, or consultation with other health care professionals. 
 If a participant dies during participation in the study or during a recognized follow-up 
period, the investigator will provide the sponsor or designee with a copy of any 
postmortem findings including histopathology. 
10.3.5. 
Reporting of SAEs  
SAE reporting via paper form 
Facsimile transmission of the SAE paper form is the preferred method to transmit this 
information to the sponsor or designee. 
Initial notification via telephone does not replace the need for the investigator to complete and 
sign the SAE CRF pages within the designated reporting time frames. 
Contacts for SAE reporting can be found in the Global Patient Safety Clinical Trial Serious 
Adverse Event Transmission Cover Sheet and Form. 
10.3.6. 
Regulatory Reporting Requirements  
SAE regulatory reporting 
Prompt notification by the investigator to the sponsor of an SAE is essential so that legal 
obligations and ethical responsibilities toward the safety of participants and the safety of 
a study intervention under clinical investigation are met. 
The sponsor has a legal responsibility to notify both the local regulatory authority and other 
regulatory agencies about the safety of a study intervention under clinical investigation. The 
sponsor will evaluate the reported SAEs, including confirmation of relatedness and assessment 
of expectedness. The sponsor has processes for safety reports for identification, recording, and 
expedited reporting of SUSARs according to local regulatory requirements. The sponsor will 
comply with country-specific regulatory requirements relating to safety reporting to the 
regulatory authority, IRB/IEC, and investigators. 
An investigator who receives an investigator safety report describing an SAE or other specific 
safety information, for example, summary or listing of SAEs, from the sponsor will review and 
then file it along with the IB and will notify the IRB/IEC, if appropriate according to local 
requirements. 
 
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10.4. 
Appendix 4: Contraceptive and Barrier Guidance  
10.4.1. 
Definitions  
Word/Phrase 
Definition 
Women of 
childbearing 
potential 
(WOCBP) 
Adult females are considered WOCBP unless they are WNOCBP.  
Women not of 
childbearing 
potential 
(WNOCBP) 
Females are considered WNOCBP if they 
 have a congenital anomaly such as Müllerian agenesis  
 are infertile due to surgical sterilization, or  
 are postmenopausal. 
Examples of surgical sterilization include hysterectomy, bilateral salpingo-
oophorectomy, bilateral salpingectomy, or bilateral oophorectomy. 
Postmenopausal 
state 
The postmenopausal state is defined as a woman 
 at any age at least 6 weeks post-surgical bilateral oophorectomy 
with or without hysterectomy, confirmed by operative note; or  
 aged at least 40 years and up to 55 years with an intact uterus, not 
on hormone therapya, who has had cessation of menses for at least 
12 consecutive months without an alternative medical cause, AND 
with a follicle-stimulating hormone >40 mIU/mL; or  
 55 years or older not on hormone therapy, who has had at least 
12 months of spontaneous amenorrhea, or 
 aged at least 55 years with a diagnosis of menopause prior to 
starting hormone replacement therapy. 
a Women should not be taking medications during amenorrhea such as oral 
contraceptives, hormones, gonadotropin-releasing hormone, anti-estrogens, 
selective estrogen receptor modulators, or chemotherapy that could induce 
transient amenorrhea. 
 
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10.4.2. 
Contraception Guidance  
10.4.2.1. Female Participants  
WOCBP who are completely abstinent as their preferred and usual lifestyle, or in a same-sex 
relationship as their preferred and usual lifestyle: 
Must…  
Must not…  
agree to either 
remain abstinent or 
stay in a same-sex 
relationship without 
sexual relationships 
with males, and not 
plan a pregnancy 
during the study 
 use periodic abstinence methods 
o calendar 
o ovulation 
o symptothermal, or 
o post-ovulation 
 declare abstinence just for the duration of a trial, or 
 use the withdrawal method 
 
WOCBP who are NOT completely abstinent as their preferred and usual lifestyle, or NOT in a 
same-sex relationship as their preferred and usual lifestyle, must do the following: 
Topic 
Condition 
Contraception 
Agree to use 1 highly effective method of contraception, or a combination 
of 2 effective methods of contraception. 
These methods of contraception must be used for the duration of the 
study. 
 
Examples of different methods of contraception:  
Methods 
Examples 
Highly effective 
contraception (less than 
1% failure rate) 
 female sterilizationa (including fallopian tube ligation, 
hysteroscopic sterilization) 
 combination oral contraceptive pill 
 progestin-only contraceptive pill (mini-pill) 
 implanted contraceptives 
 injectable contraceptives 
 contraceptive patch (only women <198 pounds or 90 kg) 
 total abstinence 
 vasectomy (for men in clinical trials and for female partner if 
only sexual partner) 
 fallopian tube implants (if confirmed by hysterosalpingogram) 
 combined contraceptive vaginal ring, or  
 intrauterine devices 
Effective contraception 
 male or female condoms with spermicide  
 diaphragms with spermicide or cervical sponges 
 barrier method with use of a spermicide 
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Methods 
Examples 
o condom with spermicide 
o diaphragm with spermicide, or 
o female condom with spermicide 
Note: Male and female condoms should not be used in combination. 
Ineffective methods of 
contraception whether 
used alone or in any 
combination 
 spermicide alone 
 periodic abstinence 
 fertility awareness (calendar method, temperature method, 
cervical mucus, or symptothermal) 
 withdrawal 
 postcoital douche, or 
 lactational amenorrhea 
a  Hysterectomy, bilateral salpingo-oophorectomy, bilateral salpingectomy, or bilateral oophorectomy are the only 
types of permanent female sterilization that allow a participant to be a WNOCBP. 
10.4.2.2. Male Participants  
No male contraception is required except in compliance with specific local government study 
requirements. 
 
 
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10.5. 
Appendix 5: Liver Safety: Suggested Actions and Follow-up 
Assessments   
Hepatic Evaluation Testing 
See Section 8.2.6.1 for guidance on appropriate test selection. 
The Lilly-designated central laboratory should complete the analysis of all selected testing 
except for testing listed in the investigator-designated local laboratory table. The central 
laboratory will report results if a validated test or calculation is available. 
In circumstances where required in accordance with local regulations, local laboratory 
testing may be performed in lieu of Lilly-designated central laboratory testing, in the 
table below. 
Local testing may be performed in addition to central testing when necessary for immediate 
participant management.  
The local laboratory must be qualified in accordance with applicable local regulations. 
Tests assayed by Lilly-designated central laboratory 
Hepatic Hematology Panel 
Hepatitis A virus (HAV) testing: 
   Hemoglobin 
    HAV total antibody 
   Hematocrit 
    HAV IgM antibody 
   Erythrocytes (RBCs - red blood cells) 
Hepatitis B virus (HBV) testing: 
   Leukocytes (WBCs - white blood cells) 
    Hepatitis B surface antigen (HBsAg) 
   Differential: 
    Hepatitis B surface antibody (anti-HBs) 
       Neutrophils, segmented 
    Hepatitis B core total antibody (anti-HBc) 
       Lymphocytes 
    Hepatitis B core IgM antibody 
       Monocytes 
    HBV DNA b 
       Basophils 
Hepatitis C virus (HCV) testing: 
       Eosinophils 
    HCV antibody 
   Platelets 
    HCV RNA b 
   Cell morphology (RBC and WBC) 
Hepatitis D virus (HDV) testing: 
Hepatic Clinical Chemistry Panel 
    HDV antibody 
   Total bilirubin 
    HDV IgM antibody 
   Direct bilirubin 
Hepatitis E virus (HEV) testing: 
   Alkaline phosphatase (ALP) 
    HEV IgG antibody 
   Alanine aminotransferase (ALT) 
    HEV IgM antibody 
   Aspartate aminotransferase (AST) 
    HEV RNA b 
   Gamma-glutamyl transferase (GGT) 
Anti-nuclear antibody (ANA) 
   Creatine kinase (CK) 
Anti-smooth muscle antibody (ASMA) a 
Hepatic Coagulation Panel 
Anti-actin antibody c 
   Prothrombin time, INR (PT-INR) 
Immunoglobulin IgA (quantitative) 
Urine Chemistry 
Immunoglobulin IgG (quantitative) 
   Drug screen 
Immunoglobulin IgM (quantitative) 
Haptoglobin 
  
 
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Tests assayed ONLY by investigator-designated local laboratory 
Acetaminophen 
Cytomegalovirus (CMV) testing: 
Alkaline phosphatase isoenzymes 
    CMV antibody 
Ceruloplasmin 
    CMV DNA b 
Copper 
Herpes simplex virus (HSV) testing: 
Ethyl alcohol (EtOH) 
    HSV (Type 1 and 2) antibody 
Phosphatidylethanol (PEth) 
    HSV (Type 1 and 2) DNA b 
Urine Chemistry 
Liver kidney microsomal type 1 (LKM-1) 
antibody 
    Ethyl glucuronide (EtG) 
Microbiology Culture: 
Epstein-Barr virus (EBV) testing: 
    Blood 
    EBV DNA b 
    Urine 
    EBV antibody 
 
a Not required if anti-actin antibody is tested. 
b Reflex/confirmation dependent on regulatory requirements, testing availability, or both. 
c Not required if anti-smooth muscle antibody (ASMA) is tested. 
 
 
 
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10.6. 
Appendix 6: Provisions for Changes in Study Conduct During 
Exceptional Circumstances  
Implementation of this appendix 
The changes to procedures described in this appendix are temporary measures intended to be 
used only during specific time periods as directed by the sponsor in partnership with the 
investigator. 
Exceptional circumstances 
Exceptional circumstances are rare events that may cause disruptions to the conduct of the study. 
Examples include pandemics or natural disasters. These disruptions may limit the ability of the 
investigators, participants, or both to attend on-site visits or to conduct planned study procedures. 
Implementing changes under exceptional circumstances 
In an exceptional circumstance, after receiving the sponsor’s written approval, sites may 
implement changes if permitted by local regulations. 
After approval by local IRBs/IECs, regulatory bodies and any other relevant local authorities, 
implementation of these exceptional circumstance changes will not typically require additional 
notification to these groups, unless they have specific requirements in which notification is 
required, for example, upon implementation and suspension of changes. All approvals and 
notifications must be retained in the study records. 
If the sponsor grants written approval for changes in study conduct, the sponsor will also provide 
additional written guidance, if needed. 
Considerations for making a change 
The prevailing consideration for making a change is ensuring the safety of study participants. 
Additional important considerations for making a change are compliance with GCP, enabling 
participants to continue safely in the study, and maintaining the integrity of the study. 
Informed consent 
Additional consent from the participant will be obtained, if required, for 
 participation in remote visits, as defined in Section “Remote Visits,” 
 a change in the method of study intervention administration,   
 dispensation of additional study intervention during an extended treatment period,  
 alternate delivery of study intervention and ancillary supplies, and 
 provision of their personal or medical information required prior to implementation of 
these activities.  
Changes in study conduct during exceptional circumstances 
Changes in study conduct not described in this appendix, or not consistent with applicable local 
regulations, are not allowed. 
The following changes in study conduct will not be considered protocol deviations. 
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Remote visits 
Types of remote visits 
Telemedicine - Telephone or technology-assisted virtual visits, or both, are acceptable to 
complete appropriate assessments. Assessments to be completed in this manner include, 
but are not limited to, AE and concomitant medications. 
Other alternative locations - Participants may visit local hospital other than the study site 
when participants cannot travel to the site due to an exceptional circumstance if written 
approval is provided by the sponsor. Procedures performed at such visits include but are 
not limited to safety monitoring (physical examination, vital signs, ECG, body 
temperature, neurological examinations) and sample collections for clinical laboratory 
tests.  
Data capture 
In source documents and the CRF, the study site should capture the visit method, with a specific 
explanation for any data missing because of missed in-person site visits. 
Safety reporting 
Regardless of the type of remote visits implemented, the protocol requirements regarding the 
reporting of AEs, SAEs, and product complaints remain unchanged.  
Return to on-site visits 
Every effort should be made to enable participants to return to on-site visits as soon as 
reasonably possible, while ensuring the safety of both the participants and the site staff. 
Screening period guidance  
To ensure safety of study participants, laboratory values and other eligibility assessments taken 
at the screening visit are valid for a maximum of 28 days.  
The following rules will be applied for active, nonrandomized participants whose participation in 
the study must be interrupted due to exceptional circumstances. 
 If screening is interrupted for less than 28 days from screening to randomization visit, the 
participant will proceed to the next study visit per the usual SoA, provided that 
randomization visit must be conducted within 28 days from first screening.  
The site should conduct the next visit if the participant’s eligibility criteria are confirmed, 
and the site should document the reason for delay. 
The site should also reconfirm the impacted participant’s consent and document this 
confirmation in the source documentation. 
 If screening is interrupted for more than 28 days from screening to randomization visit, 
the participant must be discontinued because of screening interruption due to an 
exceptional circumstance. This is documented as a screen failure in the CRF. The 
participant can reconsent and be rescreened as a new participant. This rescreen is in 
addition to the one allowed by the main protocol. The screening procedures per the usual 
SoA should be followed, starting at screening visit to ensure participant eligibility by 
randomization visit. 
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Adjustments to visit windows 
Whenever possible and safe to do so, as determined by the investigator’s discretion, participants 
should complete the usual SoA. To maximize the possibility that these visits can be conducted as 
on-site visits, the windows for visits may be adjusted, upon further guidance from the sponsor. 
This minimizes missing data and preserves the intended conduct of the study. For participants 
whose visits have extended windows, additional study intervention may need to be provided to 
avoid interruption and maintain overall integrity of the study. 
Documentation 
Changes to study conduct will be documented 
Sites will identify and document the details of how participants, visit types, and conducted 
activities were affected by exceptional circumstances. Dispensing/shipment records of study 
intervention and relevant communications, including delegation, should be filed with site study 
records. 
Source documents at alternate locations 
Source documents generated at a location other than the study site should be part of the 
investigator’s source documentation and should be transferred to the site in a secure and timely 
manner. 
 
 
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10.7. 
Appendix 7: Clinical Laboratories and Specimen Disposal Units  
  
  
  
  
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10.8. 
Appendix 8: Abbreviations and Definitions  
Term 
Definition 
abuse 
Use of a study intervention for recreational purposes or to maintain an addiction or 
dependence 
ADA 
anti-drug antibody 
AE 
adverse event 
ALP 
alkaline phosphatase 
ALT 
alanine aminotransferase 
AST 
aspartate aminotransferase 
AD 
atopic dermatitis 
blinding/masking 
A double-blind study is one in which neither the participant nor any of the investigator 
or sponsor staff who are involved in the treatment or clinical evaluation of the subjects 
are aware of the treatment received. 
CFR 
Code of Federal Regulations 
CIOMS 
Council for International Organizations of Medical Sciences 
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. 
CRF 
case report form; a printed, optical, or electronic document designed to record all of the 
protocol-required information to be reported to the sponsor for each trial participant. 
CRU 
clinical research unit 
ECG 
electrocardiogram 
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. 
GCP 
good clinical practice 
HCV 
hepatitis C virus 
IB 
Investigator’s Brochure 
ICF 
informed consent form 
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ICH 
International Council for Harmonisation 
IEC 
independent ethics committee 
IL 
interleukin 
informed consent 
A process by which a participant voluntarily confirms their willingness to participate in 
a particular study, after having been informed of all aspects of the study that are 
relevant to the participant’s decision to participate. Informed consent is documented by 
means of a written, signed and dated informed consent form. 
investigational 
product 
A pharmaceutical form of an active ingredient or placebo being tested or used as a 
reference in a clinical trial, including products already on the market when used or 
assembled (formulated or packaged) in a way different from the authorized form, or 
marketed products used for an unauthorized indication, or marketed products used to 
gain further information about the authorized form. 
IRB 
institutional review board 
ISR 
injection site reaction 
IV 
intravenous 
medication error 
Errors in the prescribing, dispensing, or administration of a study intervention, 
regardless of whether or not the medication is administered to the participant or the 
error leads to an AE. Medication error generally involve a failure to uphold one or more 
of the five “rights” of medication use: the right participant, the right drug, the right 
dose, right route, at the right time. 
In addition to the core five rights, the following may also represent medication errors:  
• dose omission associated with an AE or a product complaint 
• dispensing or use of expired medication 
• use of medication past the recommended in-use date 
• dispensing or use of an improperly stored medication 
• use of an adulterated dosage form or administration technique inconsistent with the 
medication's labeling (for example, Summary of Product Characteristics, IB, local 
label, protocol), or 
• shared use of cartridges, prefilled pens, or both. 
misuse 
Use of a study intervention for self-treatment that either is inconsistent with the 
prescribed dosing regimen, indication, or both, or is obtained without a prescription 
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 
pharmacokinetics 
Q2W 
every 2 weeks 
Q4W 
every 4 weeks 
SAE 
serious adverse event 
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SAP 
statistical analysis plan 
SC 
subcutaneous 
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 
SUSAR 
suspected unexpected serious adverse reactions 
Refers to an adverse event that occurs in a clinical trial participant, which is assessed by 
the sponsor and or study investigator as being unexpected, serious and as having a 
reasonable possibility of a causal relationship with the study intervention. 
TB 
tuberculosis 
TBL 
total bilirubin 
TE ADA 
treatment-emergent anti-drug antibody 
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. 
ULN 
upper limit of normal 
WOCBP 
women of childbearing potential 
 
 
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11. 
References  
Noonan M, Korenblat P, Mosesova S, et al. Dose-ranging study of lebrikizumab in asthmatic 
patients not receiving inhaled steroids. J Allergy Clin Immunol. 2013 Sep;132(3):567-574.e12. 
doi: 10.1016/j.jaci.2013.03.051. 
Sampson HA, Muñoz-Furlong A, Campbell RL, et al. Second symposium on the definition and 
management of anaphylaxis: summary report--Second National Institute of Allergy and 
Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J Allergy Clin Immunol. 
2006;117(2):391-397. doi:10.1016/j.jaci.2005.12.1303 
Williamson A, Hoggart B. Pain: a review of three commonly used pain rating scales. J Clin 
Nurs. 2005;14:(7)798-804. 
 
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