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ABBV-1088

Phase 1

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

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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