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ABBV-154 Dose Formulation A

Phase 1

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

ABBV-154 Dose Formulation A development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

ABBV-154 Dose Formulation A clinical trials

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
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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?

ABBV-154 Dose Formulation A is an investigational small molecule developed by AbbVie Inc. (ticker ABBV) in the immunology therapeutic area. It is a specific subcutaneous injection formulation of ABBV-154 studied in a Phase 1 clinical trial. It has been evaluated in healthy adult participants rather than in patients with a disease indication.

Who makes ABBV-154 Dose Formulation A?

ABBV-154 Dose Formulation A is made and developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie sponsored the Phase 1 study of this subcutaneous injection formulation. The asset sits within AbbVie's immunology therapeutic area.

What phase is ABBV-154 Dose Formulation A in?

ABBV-154 Dose Formulation A is in Phase 1 clinical development. Its single recorded trial, NCT05556226, has completed, and no trials of this formulation are currently active. It is an investigational agent and is not approved for any use.

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

ABBV-154 Dose Formulation A was studied in one Phase 1 trial, NCT05556226, titled a study to assess adverse events and compare how two subcutaneous ABBV-154 injection formulations move through the body of adult healthy participants. The trial enrolled 40 healthy adult volunteers in the United States, was randomized and controlled, and has completed.

What is ABBV-154 Dose Formulation A used for?

ABBV-154 Dose Formulation A has been studied in healthy adult volunteers, not in a patient population, so it has no established therapeutic use. The Phase 1 trial NCT05556226 assessed adverse events and compared how two subcutaneous ABBV-154 injection formulations move through the body. It is an investigational formulation within AbbVie's immunology area.