Clinical trial

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

Name

M24-693

Description

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.

Trial arms

Trial start

2024-01-29

Estimated PCD

2025-01-27

Trial end

2025-01-27

Status

Active (not recruiting)

Phase

Early phase I

Treatment

ABBV-141

Infusion; intravenous (IV)

Arms:

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

Placebo for ABBV-141

Infusion; IV

Arms:

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

ABBV-141

Injection; subcutaneous (SC)

Arms:

Part 1, ABBV-141 (subcutaneous [SC]), Part 2, ABBV-141 (SC)

Placebo for ABBV-141

Injection; SC

Arms:

Part 1, Placebo for ABBV-141 (SC), Part 2, Placebo for ABBV-141 (SC)

Size

Primary endpoint

Maximum Observed Plasma Concentration (Cmax) of ABBV-141

Up to Day 85

Time to Cmax (Tmax) of ABBV-141

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)

Up to Day 85

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

Up to Day 85

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

Up to Day 85

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

Up to Day 85

Dose Normalized Cmax of ABBV-141

Up to Day 85

Dose Normalized AUC of ABBV-141

Up to Day 85

Number of Adverse Events (AEs)

Baseline to Day 85

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 99, 'type': 'ESTIMATED'}}

Updated at

2024-05-02

1 organization

2 products

1 indication

Organization

AbbVie

Product

ABBV-141

Indication

Healthy Control Participants

Product

Placebo