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

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT06067568

Run by

AbbVie

People needed

50

Starts

2023-09-28

Expected to finish

2024-02-26

Last updated by the study team

2024-03-15

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Altasciences Clinical Los Angeles, Inc /ID# 260986 — Cypress, California, United States
• Acpru /Id# 259029 — Grayslake, Illinois, United States
• PPD Clinical Research Unit - Austin /ID# 260141 — Austin, Texas, United States

Full record on ClinicalTrials.gov

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