Clinical trial NCT06148181: 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
Official title: A Randomized, Double-blind, Placebo-controlled, Phase 1a Study to Evaluate the Safety and Pharmacokinetics of Single Ascending Doses of ABBV-141 in Healthy Adult Western and Asian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: ABBV-141
Healthy Volunteers
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-11-28
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
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 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 Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of ABBV-141
timeFrame: Up to Day 85
measure: Time to Cmax (Tmax) of ABBV-141
timeFrame: Up to Day 85
measure: Area Under the Serum Concentration-time Curve (AUC) of ABBV-141 from time 0 to the time of last measurable concentration (AUCt)
timeFrame: Up to Day 85
measure: AUC of ABBV-141 from Time 0 to Infinity (AUCinf)
timeFrame: Up to Day 85
measure: Terminal Phase Elimination Rate Constant (β) of ABBV-141
timeFrame: Up to Day 85
measure: Terminal Phase Elimination Half-life (t1/2) of ABBV-141
timeFrame: Up to Day 85
measure: Dose Normalized Cmax of ABBV-141
timeFrame: Up to Day 85
measure: Dose Normalized AUC of ABBV-141
timeFrame: Up to Day 85
measure: Number of Adverse Events (AEs)
timeFrame: Baseline to Day 85
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 261162
state: Illinois
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: