Healthy Volunteers
Conditions
Keywords
Lutikizumab
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.
Interventions
DRUGLutikizumab Dose A
Injection; subcutaneous (SC)
DRUGLutikizumab Dose B
Injection; subcutaneous (SC)
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Serum Concentration (Cmax) of Lutikizumab | Up to Day 8 | Cmax of lutikizumab will be assessed. |
| Time to Cmax (Tmax) of Lutikizumab | Up to Day 8 | Tmax of lutikizumab will be assessed. |
| Apparent Terminal Phase Elimination Rate Constant (β) of Lutikizumab | Up to Day 8 | Apparent terminal phase elimination rate constant (β) of lutikizumab will be assessed. |
| Terminal Phase Elimination Half-life (t1/2) of Lutikizumab | Up to Day 8 | Terminal phase elimination half-life (t1/2) of lutikizumab will be assessed. |
| Area under the Serum Concentration-time Curve (AUC) from Time 0 to the Time of the Last Measurable Concentration (AUC0-t) of Lutikizumab | Up to Day 8 | AUC0-t of lutikizumab will be assessed. |
| AUC from Time 0 to Infinity (AUC0-inf) of Lutikizumab | Up to Day 8 | AUC0-inf of lutikizumab will be assessed. |
| Number of Participants with Adverse Events (AEs) | Baseline to Day 71 | 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. |
Countries
United States
Outcome results
None listed