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ABBV-154 Dose Formulation A

Phase 1

ABBV-154 | Small molecule | Immunology |AbbVie Inc.|Last Updated: Mar 13, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

ABBV-154 Dose Formulation A · 1 trial · 1 indication

Phase 1 1
NCT05556226Study to Assess Adverse Events and Compare How Two Subcutaneous ABBV-154 Injection Formulations Move Through the Body of Adult Healthy ParticipantsABBV-154
COMPLETED40 Analytics
PHASE1COMPLETED
Study to Assess Adverse Events and Compare How Two Subcutaneous ABBV-154 Injection Formulations Move Through the Body of Adult Healthy Participants
ABBV-154
NCT0555622640
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Study Endpoints

Primary Endpoints

Maximum Observed Plasma Concentration (Cmax)
Approximately up to 58 days
Time to Maximum Observed Plasma Concentration (Tmax)
Approximately up to 58 days
Apparent Terminal Phase Elimination Rate Constant (β)
Approximately up to 58 days
The Terminal Phase Elimination Half-Life (t1/2)
Approximately up to 58 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
Approximately up to 58 days
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
Approximately up to 58 days
Number of Participants with Adverse Events
Approximately up to 72 days

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. The investigator assesses the relationship of each event to the use of study.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
ABBV-154 Dose AEXPERIMENTALParticipants will receive subcutaneous dose of ABBV-154 Dose Formulation A.
ABBV-154 Dose BEXPERIMENTALParticipants will receive subcutaneous dose of ABBV-154 Dose Formulation B.

Interventions

NameTypeDescription
ABBV-154 Dose Formulation ADRUGSubcutaneous Injection
ABBV-154 Dose Formulation BDRUGSubcutaneous Injection
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: \- Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the nearest tenth at screening and upon initial confinement. Exclusion Criteria: * Participant using any medications, vitamins and/or herbal supplements, within the 2 week period or 5 half-lives (whichever is...

Countries:United States
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Frequently asked questions about ABBV-154 Dose Formulation A

What is ABBV-154 Dose Formulation A used for?

ABBV-154 Dose Formulation A is an investigational small molecule being developed by AbbVie for immunology indications. It is currently in Phase 1 clinical development. The drug is being studied in adult healthy participants to assess adverse events and compare how two subcutaneous injection formulations move through the body.

What does ABBV-154 Dose Formulation A target?

The molecular target of ABBV-154 Dose Formulation A has not been disclosed. It is a small molecule in the immunology therapeutic area, but its specific mechanism of action is not publicly available at this time.

Who makes ABBV-154 Dose Formulation A?

ABBV-154 Dose Formulation A is developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy participants.

What phase is ABBV-154 Dose Formulation A in?

ABBV-154 Dose Formulation A is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 1 study has been completed to evaluate its safety and how it moves through the body.

What clinical trials is ABBV-154 Dose Formulation A in?

ABBV-154 Dose Formulation A has one completed Phase 1 clinical trial, NCT05556226. This study enrolled 40 healthy adult participants in the United States to assess adverse events and compare two subcutaneous injection formulations of the drug. The trial was controlled but not double-blinded.

Is ABBV-154 Dose Formulation A the same as ABBV-154?

ABBV-154 Dose Formulation A is a specific formulation of the drug ABBV-154. The clinical trial NCT05556226 compares two subcutaneous injection formulations of ABBV-154, with Dose Formulation A being one of them. The drug is being developed by AbbVie.