Relative Bioavailability of Two Lutikizumab Formulations and Pharmacokinetics, Safety, and Tolerability of Lutikizumab in Chinese Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-28

Study Completion Date

2024-02-26

Brief Summary

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The purpose of this study is to compare the bioavailability of two different formulations of lutikizumab, and to assess adverse events (AEs) and how lutikizumab moves through the body in healthy Chinese participants.

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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Part 1, Dose A

Participants will receive a single dose of Lutikizumab Dose A.

Group Type EXPERIMENTAL

Lutikizumab Dose A

Intervention Type DRUG

Injection; subcutaneous (SC)

Part 1, Dose B

Participants will receive a single dose of Lutikizumab Dose B.

Group Type EXPERIMENTAL

Lutikizumab Dose B

Intervention Type DRUG

Injection; subcutaneous (SC)

Part 2

Han Chinese participants will receive a single dose of Lutikizumab.

Group Type EXPERIMENTAL

Lutikizumab Dose A

Intervention Type DRUG

Injection; subcutaneous (SC)

Interventions

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Lutikizumab Dose A

Injection; subcutaneous (SC)

Intervention Type DRUG

Lutikizumab Dose B

Injection; subcutaneous (SC)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Male and female healthy volunteers aged between 18 and 60 years.

\-- Part 2 only: Participant must be first-generation Han Chinese of full Chinese parentage residing outside of China. Participant must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
* BMI \<= 18.0 to \<= 29.9 kg/m\^2 after rounding to the tenths decimal, at screening and upon initial confinement.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and 12-lead electrocardiogram (ECG).

Exclusion Criteria

* Use any medications, vitamins, and/or herbal supplements within the 2 week period or 5 half-lives (whichever is longer) prior to study drug administration.
* History of: epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic ,gastrointestinal, hematologic, demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease, glaucoma, psychiatric disease or disorder, or any uncontrolled medical illness.
* Prior exposure to lutikizumab.

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes