Status:
COMPLETED
Relative Bioavailability of Two Lutikizumab Formulations and Pharmacokinetics, Safety, and Tolerability of Lutikizumab in Chinese Participants
Lead Sponsor:
AbbVie
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 Chine...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 26 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06067568
Start Date
September 28 2023
End Date
February 26 2024
Last Update
March 15 2024
Active Locations (3)
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1
Altasciences Clinical Los Angeles, Inc /ID# 260986
Cypress, California, United States, 90630
2
Acpru /Id# 259029
Grayslake, Illinois, United States, 60030
3
PPD Clinical Research Unit - Austin /ID# 260141
Austin, Texas, United States, 78744