Trial Outcomes & Findings for A Study to Investigate the Safety and Pharmacokinetics of Lebrikizumab in Healthy Chinese Participants (NCT NCT06243198)

Last Updated: 2025-09-12

Results Overview

A TEAE is defined as an AE that starts during or after dosing, or starts prior to dosing and increases in severity after dosing. A 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; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; is an important medical event that may require medical or surgical intervention to prevent any of the above outcomes. A summary of TEAEs, SAEs and other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events section of this record.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

24 participants

Primary outcome timeframe

Baseline up to 120 days

Results posted on

2025-09-12

Participant Flow

Participant milestones

Participant milestones
Measure	250 mg Lebrikizumab Participants received single dose of 250 milligram (mg) lebrikizumab administered as subcutaneous (SC) injection on day 1.	500 mg Lebrikizumab Participants received single dose of 500 mg lebrikizumab administered as SC injection on day 1.	Placebo Participants received single dose of placebo administered as SC injection on day 1.
Overall Study STARTED	10	10	4
Overall Study Received at Least One Dose of Study Drug	10	10	4
Overall Study COMPLETED	10	10	4
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Study to Investigate the Safety and Pharmacokinetics of Lebrikizumab in Healthy Chinese Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	250 mg Lebrikizumab n=10 Participants Participants received single dose of 250 mg lebrikizumab administered as SC injection on day 1.	500 mg Lebrikizumab n=10 Participants Participants received single dose of 500 mg lebrikizumab administered as SC injection on day 1.	Placebo n=4 Participants Participants received single dose of placebo administered as SC injection on day 1.	Total n=24 Participants Total of all reporting groups
Age, Continuous	33.1 years STANDARD_DEVIATION 8.08 • n=93 Participants	29.1 years STANDARD_DEVIATION 5.95 • n=4 Participants	29.0 years STANDARD_DEVIATION 6.22 • n=27 Participants	30.8 years STANDARD_DEVIATION 6.97 • n=483 Participants
Sex: Female, Male Female	2 Participants n=93 Participants	3 Participants n=4 Participants	2 Participants n=27 Participants	7 Participants n=483 Participants
Sex: Female, Male Male	8 Participants n=93 Participants	7 Participants n=4 Participants	2 Participants n=27 Participants	17 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=93 Participants	10 Participants n=4 Participants	4 Participants n=27 Participants	24 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	10 Participants n=93 Participants	10 Participants n=4 Participants	4 Participants n=27 Participants	24 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) White	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Region of Enrollment China	10 Participants n=93 Participants	10 Participants n=4 Participants	4 Participants n=27 Participants	24 Participants n=483 Participants

PRIMARY outcome

Timeframe: Baseline up to 120 days

Population: All enrolled participants who received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	250 mg Lebrikizumab n=10 Participants Participants received single dose of 250 mg lebrikizumab administered as SC injection on day 1.	500 mg Lebrikizumab n=10 Participants Participants received single dose of 500 mg lebrikizumab administered as SC injection on day 1.	Placebo n=4 Participants Participants received single dose of placebo administered as SC injection on day 1.
Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) TEAEs	10 participants	10 participants	3 participants
Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) SAEs	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Day 1: Predose and Days 2, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 120 post dose

Population: All enrolled participants who received at least one dose of lebrikizumab and had evaluable PK data.

PK: Cmax of Lebrikizumab is reported.

Outcome measures

Outcome measures
Measure	250 mg Lebrikizumab n=10 Participants Participants received single dose of 250 mg lebrikizumab administered as SC injection on day 1.	500 mg Lebrikizumab n=10 Participants Participants received single dose of 500 mg lebrikizumab administered as SC injection on day 1.	Placebo Participants received single dose of placebo administered as SC injection on day 1.
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of Lebrikizumab	26.8 microgram per millilitre (µg/mL) Geometric Coefficient of Variation 41.9	71.2 microgram per millilitre (µg/mL) Geometric Coefficient of Variation 22.1	—

SECONDARY outcome

Timeframe: Day 1: Predose and Days 2, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 120 post dose

Population: All enrolled participants who received at least one dose of lebrikizumab and had evaluable PK data.

PK: AUC0-∞ of Lebrikizumab is reported.

Outcome measures

Outcome measures
Measure	250 mg Lebrikizumab n=10 Participants Participants received single dose of 250 mg lebrikizumab administered as SC injection on day 1.	500 mg Lebrikizumab n=10 Participants Participants received single dose of 500 mg lebrikizumab administered as SC injection on day 1.	Placebo Participants received single dose of placebo administered as SC injection on day 1.
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Lebrikizumab	1130 microgramday per milliliter (μgday/mL) Geometric Coefficient of Variation 42.2	2940 microgramday per milliliter (μgday/mL) Geometric Coefficient of Variation 11.2	—

SECONDARY outcome

Timeframe: Day 1: Predose and Days 2, 5, 8, 11, 15, 22, 29, 43, 57, 71, 85, and 120 post dose

Population: All enrolled participants who received at least one dose of lebrikizumab and had evaluable PK data.

PK: AUC0-tlast of Lebrikizumab is reported.

Outcome measures

Outcome measures
Measure	250 mg Lebrikizumab n=10 Participants Participants received single dose of 250 mg lebrikizumab administered as SC injection on day 1.	500 mg Lebrikizumab n=10 Participants Participants received single dose of 500 mg lebrikizumab administered as SC injection on day 1.	Placebo Participants received single dose of placebo administered as SC injection on day 1.
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Lebrikizumab	1080 μg*day/mL Geometric Coefficient of Variation 40.8	2800 μg*day/mL Geometric Coefficient of Variation 11.7	—

Adverse Events

250 mg Lebrikizumab

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

500 mg Lebrikizumab

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 08005455979

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60

Measure	250 mg Lebrikizumab n=10 participants at risk Participants received single dose of 250 mg lebrikizumab administered as SC injection on day 1.	500 mg Lebrikizumab n=10 participants at risk Participants received single dose of 500 mg lebrikizumab administered as SC injection on day 1.	Placebo n=4 participants at risk Participants received single dose of placebo administered as SC injection on day 1.
Blood and lymphatic system disorders Eosinophilia	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Eye disorders Dry eye	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Mouth ulceration	30.0% 3/10 • Number of events 4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Gastrointestinal disorders Noninfective gingivitis	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Infections and infestations Folliculitis	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Infections and infestations Hordeolum	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	40.0% 4/10 • Number of events 5 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	20.0% 2/10 • Number of events 2 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Investigations Alanine aminotransferase increased	20.0% 2/10 • Number of events 2 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Investigations Aspartate aminotransferase increased	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	20.0% 2/10 • Number of events 2 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Investigations Bilirubin conjugated increased	10.0% 1/10 • Number of events 2 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	30.0% 3/10 • Number of events 3 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Investigations Blood bilirubin increased	10.0% 1/10 • Number of events 2 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Investigations Blood creatine phosphokinase increased	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	30.0% 3/10 • Number of events 4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Investigations Blood triglycerides increased	20.0% 2/10 • Number of events 5 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Investigations Blood uric acid increased	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 2 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Investigations Eosinophil count increased	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Investigations Gamma-glutamyltransferase increased	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Investigations Lymphocyte count decreased	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Investigations Neutrophil count decreased	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Investigations Neutrophil count increased	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	30.0% 3/10 • Number of events 3 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Investigations Urinary occult blood positive	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Investigations Urine ketone body present	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Investigations Urobilinogen urine increased	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Investigations Weight decreased	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Investigations Weight increased	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Investigations White blood cell count decreased	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Nervous system disorders Presyncope	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Psychiatric disorders Insomnia	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Acne	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	25.0% 1/4 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Erythema	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash	0.00% 0/10 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	10.0% 1/10 • Number of events 1 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.	0.00% 0/4 • Baseline Up to 120 Days All enrolled participants who received at least one dose of study drug.