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ABBV-1088

Phase 1

Healthy Volunteers | Small molecule | Other |AbbVie Inc.|Trials Updated: Feb 19, 2025

Development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Aug 2024

Target and mechanism

ModalitySmall molecule

Also known as Drug: ABBV-1088

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

ABBV-1088 · 1 trial · 1 indication

Phase 1 1
NCT06414798A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABBV-1088 Oral Dose in Healthy Adult Participants.Healthy Volunteers
COMPLETED60 Analytics
PHASE1COMPLETED
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABBV-1088 Oral Dose in Healthy Adult Participants.
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Study Endpoints

Primary Endpoints

Maximum Plasma Concentration (Cmax) of ABBV-1088
Up to approximately 11 days

Cmax of ABBV-1088

Time to Cmax (Tmax) of ABBV-1088
Up to approximately 11 days

Tmax of ABBV-1088

Terminal Phase Elimination Rate Constant (Beta) of ABBV-1088
Up to approximately 11 days

Terminal phase elimination rate constant (beta) of ABBV-1088

Terminal Phase Elimination Half-Life (t1/2) of ABBV-1088
Up to approximately 11 days

Terminal phase elimination half-life of ABBV-1088

Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-1088
Up to approximately 11 days

AUCt of ABBV-1088

Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-1088
Up to approximately 11 days

AUCinf of ABBV-1088

Number of Participants With Adverse Events (AEs)
Up to Day 32

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
MaskingTRIPLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Group 1- ABBV-1088 Dose AEXPERIMENTALParticipants will receive single dose of ABBV-1088 dose A on day 1
Group 1- PlaceboEXPERIMENTALParticipants will receive single dose of placebo day 1
Group 2- ABBV-1088 Dose BEXPERIMENTALParticipants will receive single dose of ABBV-1088 dose B on day 1
Group 2- PlaceboEXPERIMENTALParticipants will receive single dose of placebo day 1
Group 3- ABBV-1088 Dose CEXPERIMENTALParticipants will receive single dose of ABBV-1088 dose C on day 1
Group 3- PlaceboEXPERIMENTALParticipants will receive single dose of placebo day 1
Group 4- ABBV-1088 Dose DEXPERIMENTALParticipants will receive single dose of ABBV-1088 dose D on day 1
Group 4- PlaceboEXPERIMENTALParticipants will receive single dose of placebo day 1
Group 5- ABBV-1088 Dose EEXPERIMENTALParticipants will receive single dose of ABBV-1088 dose E on day 1
Group 5- PlaceboEXPERIMENTALParticipants will receive single dose of placebo day 1
Group 6- ABBV-1088 Dose FEXPERIMENTALParticipants will receive single dose of ABBV-1088 dose F on day 1
Group 6- PlaceboEXPERIMENTALParticipants will receive single dose of placebo day 1

Interventions

NameTypeDescription
Drug: ABBV-1088DRUG• Oral Capsule
Drug: Placebo for ABBV-1088DRUG• Oral Capsule
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * BMI is ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal at screening. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG Exclusion Criteria: * History of card...

Countries:United States
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Frequently asked questions about ABBV-1088

What is ABBV-1088?

ABBV-1088 is an investigational small molecule drug developed by AbbVie Inc. It has been studied in a Phase 1 clinical trial in healthy adult volunteers to assess its safety, tolerability, and pharmacokinetics. It is not approved for any indication and remains in clinical development.

What is ABBV-1088 used for?

ABBV-1088 is not approved for any medical use. It has been tested only in healthy volunteers as part of a Phase 1 study, not in patients with a specific disease. Its potential therapeutic applications have not been established.

Who makes ABBV-1088?

ABBV-1088 is being developed by AbbVie Inc., which trades on the New York Stock Exchange under the ticker ABBV. AbbVie is the sponsor of the clinical program for this investigational small molecule.

What phase is ABBV-1088 in?

ABBV-1088 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The drug has not received FDA approval and remains investigational.

What clinical trials is ABBV-1088 in?

ABBV-1088 has been evaluated in one completed Phase 1 trial, NCT06414798, titled "A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABBV-1088 Oral Dose in Healthy Adult Participants." The trial enrolled 60 healthy adults in the United States and was randomized, double-blind, and controlled.

Is ABBV-1088 the same as Drug: ABBV-1088?

Yes, ABBV-1088 is also referred to as Drug: ABBV-1088. Both names refer to the same investigational small molecule developed by AbbVie Inc. for study in healthy volunteers.