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

NCT06067568 | Completed Phase 1

• 1 other identifier: M24-465
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Lutikizumab

Outcome Measures

Primary Outcomes (7)

• Maximum Observed Serum Concentration (Cmax) of Lutikizumab

  Cmax of lutikizumab will be assessed.

  Up to Day 8

• Time to Cmax (Tmax) of Lutikizumab

  Tmax of lutikizumab will be assessed.

  Up to Day 8

• Apparent Terminal Phase Elimination Rate Constant (β) of Lutikizumab

  Apparent terminal phase elimination rate constant (β) of lutikizumab will be assessed.

  Up to Day 8

• Terminal Phase Elimination Half-life (t1/2) of Lutikizumab

  Terminal phase elimination half-life (t1/2) of lutikizumab will be assessed.

  Up to Day 8

• Area under the Serum Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of Lutikizumab

  AUC0-t of lutikizumab will be assessed.

  Up to Day 8

• AUC from Time 0 to Infinity (AUC0-inf) of Lutikizumab

  AUC0-inf of lutikizumab will be assessed.

  Up to Day 8

• Number of Participants with Adverse Events (AEs)

  An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

  Baseline to Day 71

Study Arms (3)

Part 1, Dose A

EXPERIMENTAL

Participants will receive a single dose of Lutikizumab Dose A.

Drug: Lutikizumab Dose A

Part 1, Dose B

EXPERIMENTAL

Participants will receive a single dose of Lutikizumab Dose B.

Drug: Lutikizumab Dose B

Part 2

EXPERIMENTAL

Han Chinese participants will receive a single dose of Lutikizumab.

Drug: Lutikizumab Dose A

Interventions

Lutikizumab Dose A DRUG

Injection; subcutaneous (SC)

Part 1, Dose A; Part 2

Lutikizumab Dose B DRUG

Injection; subcutaneous (SC)

Part 1, Dose B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (3)

Altasciences Clinical Los Angeles, Inc /ID# 260986

Cypress, California, 90630, United States

Location

Acpru /Id# 259029

Grayslake, Illinois, 60030, United States

Location

PPD Clinical Research Unit - Austin /ID# 260141

Austin, Texas, 78744, United States

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: October 5, 2023
• Study Start: September 28, 2023
• Primary Completion: February 26, 2024
• Study Completion: February 26, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)