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ABBV-141

Phase 1

Undisclosed | Small molecule | Other |AbbVie Inc.|Trials Updated: Jan 23, 2025

ABBV-141 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2023

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

ABBV-141 clinical trials

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
Healthy VolunteersUnlock trial analytics

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?

ABBV-141 is an investigational small molecule drug developed by AbbVie Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers. The specific disease or condition it is intended to treat has not been disclosed.

Who is developing ABBV-141?

ABBV-141 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker symbol ABBV. AbbVie is the sponsor of the clinical trial evaluating the drug.

What phase is ABBV-141 in?

ABBV-141 is in Phase 1 clinical development. One Phase 1 trial has been completed. The drug is investigational and has not been approved by the FDA for any indication.

What clinical trials is ABBV-141 in?

ABBV-141 has been evaluated in a single Phase 1 trial, NCT06148181, titled "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." The trial enrolled 41 healthy volunteers in the United States and is completed.

How was the Phase 1 trial of ABBV-141 designed?

The Phase 1 trial NCT06148181 was a randomized, double-blind, placebo-controlled study. It evaluated single ascending doses of ABBV-141 in 41 healthy adult participants, including Western and Asian volunteers, and assessed adverse events and how the drug moves through the body.