RecruitingPhase 1NCT06673238

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

A First-In-Human Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-722 Following Single and Multiple Ascending Doses in Healthy Adult Subjects and Single Doses in Healthy Adult Asian Subjects

Sponsor

AbbVie

Enrollment

96 participants

Start Date

Oct 29, 2024

Study Type

INTERVENTIONAL

Conditions

Healthy Volunteer

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria9

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 Criteria3

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.

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