A Study to Assess How the Drug Moves Through the Body, Adverse Events, and Tolerability of Oral ABBV-722 Capsules of Single and Multiple Ascending Doses in Adult Participants and Single Doses in Adult Asian Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-29

Study Completion Date

2026-04-30

Brief Summary

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This is a Phase 1, first-in-human study to investigate safety, tolerability, and pharmacokinetics of ABBV-722 after oral dosing in healthy adult participants.

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part 1: Group 1

Participants will receive a single dose of either ABBV-722 Dose A or placebo.

Group Type EXPERIMENTAL

ABBV-722

Intervention Type DRUG

Oral Capsule

Placebo

Intervention Type DRUG

Oral Capsule

Part 1: Group 2

Participants will receive a single dose of either ABBV-722 Dose B or placebo.

Group Type EXPERIMENTAL

ABBV-722

Intervention Type DRUG

Oral Capsule

Placebo

Intervention Type DRUG

Oral Capsule

Part 1: Group 3

Participants will receive a single dose of either ABBV-722 Dose C or placebo.

Group Type EXPERIMENTAL

ABBV-722

Intervention Type DRUG

Oral Capsule

Placebo

Intervention Type DRUG

Oral Capsule

Part 1: Group 4

Participants will receive a single dose of either ABBV-722 Dose TBD or placebo.

Group Type EXPERIMENTAL

ABBV-722

Intervention Type DRUG

Oral Capsule

Placebo

Intervention Type DRUG

Oral Capsule

Part 1: Group 5

Participants will receive a single dose of either ABBV-722 Dose TBD or placebo.

Group Type EXPERIMENTAL

ABBV-722

Intervention Type DRUG

Oral Capsule

Placebo

Intervention Type DRUG

Oral Capsule

Part 2: Group 6

Participants who are Han Chinese will receive a single dose of ABBV-722 Dose D.

Group Type EXPERIMENTAL

ABBV-722

Intervention Type DRUG

Oral Capsule

Part 2: Group 7

Participants who are Japanese will receive a single dose of ABBV-722 Dose D.

Group Type EXPERIMENTAL

ABBV-722

Intervention Type DRUG

Oral Capsule

Part 3: Group 8

Participants will receive either ABBV-722 Dose E or placebo for 14 days.

Group Type EXPERIMENTAL

ABBV-722

Intervention Type DRUG

Oral Capsule

Placebo

Intervention Type DRUG

Oral Capsule

Part 3: Group 9

Participants will receive either ABBV-722 Dose F or placebo for 14 days.

Group Type EXPERIMENTAL

ABBV-722

Intervention Type DRUG

Oral Capsule

Placebo

Intervention Type DRUG

Oral Capsule

Part 3: Group 10

Participants will receive either ABBV-722 Dose A or placebo for 14 days.

Group Type EXPERIMENTAL

ABBV-722

Intervention Type DRUG

Oral Capsule

Placebo

Intervention Type DRUG

Oral Capsule

Part 3: Group 11

Participants will receive either ABBV-722 Dose G or placebo for 14 days.

Group Type EXPERIMENTAL

ABBV-722

Intervention Type DRUG

Oral Capsule

Placebo

Intervention Type DRUG

Oral Capsule

Part 3: Group 12

Participants will receive either ABBV-722 Dose TBD or placebo for 14 days.

Group Type EXPERIMENTAL

ABBV-722

Intervention Type DRUG

Oral Capsule

Placebo

Intervention Type DRUG

Oral Capsule

Interventions

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ABBV-722

Oral Capsule

Intervention Type DRUG

Placebo

Oral Capsule

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Laboratory values meet the criteria specified in the protocol.
* 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).
* Part 2 only: Healthy Han Chinese and Japanese individuals between 18 and 65 years of age, inclusive at the time of Screening.

* Participant must be first- or second-generation Han Chinese of full Chinese parentage (both parents of Han Chinese descent), residing outside of China. Participants must be in general good health and maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.
* First-generation participants will have been born in China to two parents and four grandparents, who were also born in China, and are of full Chinese descent.
* Second-generation participants born outside of China must have two parents and four grandparents born in China and are of full Chinese descent. OR
* Participant must be first- or second-generation Japanese of full Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health and maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.
* First-generation participants will have been born in Japan to two parents and four grandparents, who were also born in Japan, and are of full Japanese descent.
* Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan and are of full Japanese descent.

Exclusion Criteria

* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
* Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study drug administration.
* Use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes