Clinical trial NCT06067568: Relative Bioavailability of Two Lutikizumab Formulations and Pharmacokinetics, Safety, and Tolerability of Lutikizumab in Chinese Participants
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Lutikizumab
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-10-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Maximum Observed Serum Concentration (Cmax) of Lutikizumab
timeFrame: Up to Day 8
measure: Time to Cmax (Tmax) of Lutikizumab
timeFrame: Up to Day 8
measure: Apparent Terminal Phase Elimination Rate Constant (β) of Lutikizumab
timeFrame: Up to Day 8
measure: Terminal Phase Elimination Half-life (t1/2) of Lutikizumab
timeFrame: Up to Day 8
measure: Area under the Serum Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of Lutikizumab
timeFrame: Up to Day 8
measure: AUC from Time 0 to Infinity (AUC0-inf) of Lutikizumab
timeFrame: Up to Day 8
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Baseline to Day 71
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Altasciences Clinical Los Angeles, Inc /ID# 260986
state: California
city: Grayslake
country: United States
facility: Acpru /Id# 259029
state: Illinois
city: Austin
country: United States
facility: PPD Clinical Research Unit - Austin /ID# 260141
state: Texas
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: