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

AbbVie

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Lutikizumab Dose B; Drug: Lutikizumab Dose A

Study type: Interventional

Funder types: Industry

Identifiers

NCT06067568

M24-465

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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50 participants in 3 patient groups

Part 1, Dose A

Experimental group

Description:

Participants will receive a single dose of Lutikizumab Dose A.

Treatment:

Drug: Lutikizumab Dose A

Part 1, Dose B

Experimental group

Description:

Participants will receive a single dose of Lutikizumab Dose B.

Treatment:

Drug: Lutikizumab Dose B

Part 2

Experimental group

Description:

Han Chinese participants will receive a single dose of Lutikizumab.

Treatment:

Drug: Lutikizumab Dose A