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

Part of paid clinical trials in Cypress, California.

Sponsor
AbbVie
Study ID
NCT06067568
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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 Dates

Start date
Sep 28, 2023
Status verified
Mar 2024
Primary completion
Feb 26, 2024
Completion
Feb 26, 2024

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Part 1, Dose A
    Participants will receive a single dose of Lutikizumab Dose A.
  • Experimental: Part 1, Dose B
    Participants will receive a single dose of Lutikizumab Dose B.
  • Experimental: Part 2
    Han Chinese participants will receive a single dose of Lutikizumab.

Primary Outcome Measure

Maximum Observed Serum Concentration (Cmax) of Lutikizumab [ Time Frame: Up to Day 8 ]

Locations (3)

FacilityCityStateZIPSite coordinators
Altasciences Clinical Los Angeles, Inc /ID# 260986CypressCalifornia90630-
Acpru /Id# 259029GrayslakeIllinois60030-
PPD Clinical Research Unit - Austin /ID# 260141AustinTexas78744-

Find similar trials in Cypress, CA

By research site
Altasciences Clinical Los Angeles, Inc· Cypress, CAAcpru· Grayslake, ILPPD Clinical Research Unit - Austin· Austin, TX

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