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

NCT06148181 | Completed Phase 1

• 1 other identifier: M24-693
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Keywords

ABBV-141; Healthy Volunteers

Outcome Measures

Primary Outcomes (9)

• Maximum Observed Plasma Concentration (Cmax) of ABBV-141

  Cmax of ABBV-141 will be assessed.

  Up to Day 85

• Time to Cmax (Tmax) of ABBV-141

  Tmax of ABBV-141 will be assessed.

  Up to Day 85

• Area Under the Serum Concentration-time Curve (AUC) of ABBV-141 from time 0 to the time of last measurable concentration (AUCt)

  AUCt of ABBV-141 will be determined.

  Up to Day 85

• AUC of ABBV-141 from Time 0 to Infinity (AUCinf)

  AUCinf of ABBV-141 will be assessed.

  Up to Day 85

• Terminal Phase Elimination Rate Constant (β) of ABBV-141

  Terminal phase elimination rate constant (β) of ABBV-141 will be assessed.

  Up to Day 85

• Terminal Phase Elimination Half-life (t1/2) of ABBV-141

  Terminal phase elimination half-life (t1/2) of ABBV-141 will be assessed.

  Up to Day 85

• Dose Normalized Cmax of ABBV-141

  Dose normalized Cmax of ABBV-141 will be assessed.

  Up to Day 85

• Dose Normalized AUC of ABBV-141

  Dose normalized AUC of ABBV-141 will be assessed.

  Up to Day 85

• Number of Adverse Events (AEs)

  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.

  Baseline to Day 85

Study Arms (8)

Part 1, ABBV-141 (Intravenous [IV])

EXPERIMENTAL

Western participants will receive a single IV dose of ABBV-141.

Drug: ABBV-141

Part 1, Placebo for ABBV-141 (IV)

PLACEBO COMPARATOR

Western participants will receive a single IV dose of placebo for ABBV-141.

Drug: Placebo for ABBV-141

Part 1, ABBV-141 (subcutaneous [SC])

EXPERIMENTAL

Western participants will receive a single SC dose of ABBV-141.

Drug: ABBV-141

Part 1, Placebo for ABBV-141 (SC)

PLACEBO COMPARATOR

Western participants will receive a single SC dose of placebo for ABBV-141.

Drug: Placebo for ABBV-141

Part 2, ABBV-141 (IV)

EXPERIMENTAL

Asian participants will receive a single IV dose of ABBV-141.

Drug: ABBV-141

Part 2, Placebo for ABBV-141 (IV)

PLACEBO COMPARATOR

Asian participants will receive a single IV dose of placebo for ABBV-141.

Drug: Placebo for ABBV-141

Part 2, ABBV-141 (SC)

EXPERIMENTAL

Asian participants will receive a single SC dose of ABBV-141.

Drug: ABBV-141

Part 2, Placebo for ABBV-141 (SC)

PLACEBO COMPARATOR

Asian participants will receive a single SC dose of placebo for ABBV-141.

Drug: Placebo for ABBV-141

Interventions

ABBV-141 DRUG

Infusion; intravenous (IV)

Part 1, ABBV-141 (Intravenous [IV]); Part 2, ABBV-141 (IV)

Placebo for ABBV-141 DRUG

Infusion; IV

Part 1, Placebo for ABBV-141 (IV); Part 2, Placebo for ABBV-141 (IV)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 261162

Grayslake, Illinois, 60030, United States

Location

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2023
• First Posted: November 28, 2023
• Study Start: January 29, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)