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

Healthy Volunteers Clinical Trial

Official title:

A Phase 1 Study in Healthy Subjects to Evaluate the Relative Bioavailability of Two Lutikizumab Formulations and to Evaluate Lutikizumab Pharmacokinetics, Safety, and Tolerability in Healthy Chinese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06067568
• Other study ID #: M24-465
• Status: Completed
• Phase: Phase 1
• Start date: September 28, 2023
• Est. completion date: February 26, 2024

Study information

• Verified date: March 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 26, 2024
• Est. primary completion date: February 26, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• Lutikizumab Dose A
Injection; subcutaneous (SC)
• Lutikizumab Dose B
Injection; subcutaneous (SC)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Observed Serum Concentration (Cmax) of Lutikizumab	Cmax of lutikizumab will be assessed.	Up to Day 8
Primary	Time to Cmax (Tmax) of Lutikizumab	Tmax of lutikizumab will be assessed.	Up to Day 8
Primary	Apparent Terminal Phase Elimination Rate Constant (ß) of Lutikizumab	Apparent terminal phase elimination rate constant (ß) of lutikizumab will be assessed.	Up to Day 8
Primary	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
Primary	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
Primary	AUC from Time 0 to Infinity (AUC0-inf) of Lutikizumab	AUC0-inf of lutikizumab will be assessed.	Up to Day 8
Primary	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

External Links

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