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ABBV-141

Phase 1

Healthy Volunteers | Small molecule | Other |AbbVie Inc.|Last Updated: Jan 23, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment41

FDA Designations

No designations recorded

Clinical trial landscape

ABBV-141 · 1 trial · 1 indication

Phase 1 1
NCT06148181A Study to Evaluate Adverse Events and How Single Ascending Doses of ABBV-141 Move Through the Body of Healthy Adult Western and Asian ParticipantsHealthy Volunteers
COMPLETED41 Analytics
PHASE1COMPLETED
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
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Study Endpoints

Primary Endpoints

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.

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.

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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Part 1, ABBV-141 (Intravenous [IV])EXPERIMENTALWestern participants will receive a single IV dose of ABBV-141.
Part 1, Placebo for ABBV-141 (IV)PLACEBO_COMPARATORWestern participants will receive a single IV dose of placebo for ABBV-141.
Part 1, ABBV-141 (subcutaneous [SC])EXPERIMENTALWestern participants will receive a single SC dose of ABBV-141.
Part 1, Placebo for ABBV-141 (SC)PLACEBO_COMPARATORWestern participants will receive a single SC dose of placebo for ABBV-141.
Part 2, ABBV-141 (IV)EXPERIMENTALAsian participants will receive a single IV dose of ABBV-141.
Part 2, Placebo for ABBV-141 (IV)PLACEBO_COMPARATORAsian participants will receive a single IV dose of placebo for ABBV-141.
Part 2, ABBV-141 (SC)EXPERIMENTALAsian participants will receive a single SC dose of ABBV-141.
Part 2, Placebo for ABBV-141 (SC)PLACEBO_COMPARATORAsian participants will receive a single SC dose of placebo for ABBV-141.

Interventions

NameTypeDescription
ABBV-141DRUGInfusion; intravenous (IV)
Placebo for ABBV-141DRUGInfusion; IV
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

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 onl...

Countries:United States
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Frequently asked questions about ABBV-141

What is ABBV-141 used for?

ABBV-141 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating how single ascending doses of the drug move through the body of healthy adult Western and Asian participants.

Who makes ABBV-141?

ABBV-141 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting early-stage clinical research on this investigational small molecule.

What phase is ABBV-141 in?

ABBV-141 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and how it is processed by the body.

What clinical trials is ABBV-141 in?

ABBV-141 has one completed Phase 1 clinical trial, registered as NCT06148181. The study evaluated adverse events and how single ascending doses of ABBV-141 move through the body of healthy adult Western and Asian participants in the United States.

Is ABBV-141 a small molecule?

Yes, ABBV-141 is a small molecule drug. It is being investigated in a Phase 1 clinical trial involving healthy volunteers, with the study designed as a randomized, double-blind, placebo-controlled trial.