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Completed

NCT Number: NCT06673238

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

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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Key information

Conditions

Healthy Volunteer

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Clinical Los Angeles /ID# 280183, Cypress, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ABBV-722

Drug

Oral Capsule

Placebo

Drug

Oral Capsule

Primary outcomes

  1. Number of Participants with Adverse Events Reported During Safety Evaluations

    Time frame: Up to Day 44

    Safety evaluations will include AE monitoring, vital sign measurements (including orthostatic blood pressure and pulse rate), ECG variables, and clinical laboratory testing (hematology, chemistry, and urinalysis) as a measure of safety and tolerability for the entire study duration. Clinically significant abnormal changes in physical examination findings will be reported as AEs.

  2. Maximum Plasma Concentration (Cmax) of ABBV-722

    Time frame: Up to Day 21

    Cmax of ABBV-722.

  3. Time to Cmax (Tmax) of ABBV-722

    Time frame: Up to Day 21

    Tmax of ABBV-722.

  4. For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUCt) of ABBV-722

    Time frame: Up to Day 8

    AUCt of ABBV-722.

  5. For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUCinf) of ABBV-722

    Time frame: Up to Day 8

    AUCinf of ABBV-722

  6. For Part 3: Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-722

    Time frame: Up to Day 21

    Ctrough of ABBV-722.

  7. For Part 3: AUC from Time 0 to the End of Dosing Interval (AUCtau) Following the First and Last Doses of ABBV-722

    Time frame: Up to Day 21

    AUC from AUCtau following the first and last doses of ABBV-722.

  8. Terminal Phase Elimination Rate Constant (Beta) of ABBV-722

    Time frame: Up to Day 21

    Beta of ABBV-722.

  9. Terminal Phase Elimination Half-Life (t1/2) of ABBV-722

    Time frame: Up to Day 21

    t1/2 of ABBV-722.

  10. Dose Normalized Cmax

    Time frame: Up to Day 21

    Dose normalized Cmax.

  11. Dose Normalized AUCs

    Time frame: Up to Day 21

    Dose normalized AUCs.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 4, 2024
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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