Status:
COMPLETED
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
Lead Sponsor:
AbbVie
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
January 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT06148181
Start Date
January 29 2024
End Date
December 30 2024
Last Update
January 23 2025
Active Locations (1)
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1
Acpru /Id# 261162
Grayslake, Illinois, United States, 60030