A Study to Evaluate Adverse Events and How Single Ascending Doses of ABBV-141 Move Through the Body of Healthy Adult Western and Asian Participants
- Registration Number
- NCT06148181
- Lead Sponsor
- AbbVie
- Brief Summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity after single ascending doses (SAD) of ABBV-141 in healthy adult Western and Asian participants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal.
For Part 2 only:
-Han Chinese ethnicity or Japanese ethnicity based on the following criteria:
- Han Chinese: First-generation Han Chinese with both parents of Han Chinese descent.
- Japanese: First- or second-generation Japanese with both parents and all four grandparents born in Japan and of Japanese descent.
- History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, or psychiatric disease or disorder, or any uncontrolled medical illness.
- History of any clinically significant sensitivity or allergy to any medication, topical creams, or food.
Additionally for Part 1, only:
- Presence of foreign bodies, local irritation or infections, active skin diseases, tattoos, and/or scars on the thighs which may preclude the skin biopsy collection site planned as per schedule of activities.
- History of bruising easily, bleeding disorders, thrombocytopenia, or hypo-coagulation disorder.
- History of sensitivity to or allergies to adhesives or evidence of fragile or easily damaged skin.
- Evidence of hypertrophic scarring.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1, ABBV-141 (Intravenous [IV]) ABBV-141 Western participants will receive a single IV dose of ABBV-141. Part 1, Placebo for ABBV-141 (IV) Placebo for ABBV-141 Western participants will receive a single IV dose of placebo for ABBV-141. Part 1, ABBV-141 (subcutaneous [SC]) ABBV-141 Western participants will receive a single SC dose of ABBV-141. Part 1, Placebo for ABBV-141 (SC) Placebo for ABBV-141 Western participants will receive a single SC dose of placebo for ABBV-141. Part 2, ABBV-141 (IV) ABBV-141 Asian participants will receive a single IV dose of ABBV-141. Part 2, Placebo for ABBV-141 (IV) Placebo for ABBV-141 Asian participants will receive a single IV dose of placebo for ABBV-141. Part 2, ABBV-141 (SC) ABBV-141 Asian participants will receive a single SC dose of ABBV-141. Part 2, Placebo for ABBV-141 (SC) Placebo for ABBV-141 Asian participants will receive a single SC dose of placebo for ABBV-141.
- Primary Outcome Measures
Name Time Method AUC of ABBV-141 from Time 0 to Infinity (AUCinf) Up to Day 85 AUCinf of ABBV-141 will be assessed.
Terminal Phase Elimination Rate Constant (β) of ABBV-141 Up to Day 85 Terminal phase elimination rate constant (β) of ABBV-141 will be assessed.
Terminal Phase Elimination Half-life (t1/2) of ABBV-141 Up to Day 85 Terminal phase elimination half-life (t1/2) of ABBV-141 will be assessed.
Dose Normalized Cmax of ABBV-141 Up to Day 85 Dose normalized Cmax of ABBV-141 will be assessed.
Dose Normalized AUC of ABBV-141 Up to Day 85 Dose normalized AUC of ABBV-141 will be assessed.
Number of Adverse Events (AEs) Baseline to Day 85 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.
Maximum Observed Plasma Concentration (Cmax) of ABBV-141 Up to Day 85 Cmax of ABBV-141 will be assessed.
Time to Cmax (Tmax) of ABBV-141 Up to Day 85 Tmax of ABBV-141 will be assessed.
Area Under the Serum Concentration-time Curve (AUC) of ABBV-141 from time 0 to the time of last measurable concentration (AUCt) Up to Day 85 AUCt of ABBV-141 will be determined.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Acpru /Id# 261162
🇺🇸Grayslake, Illinois, United States
Acpru /Id# 261162🇺🇸Grayslake, Illinois, United States