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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: Placebo; Drug: ABBV-722

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: ABBVIE CALL CENTER; Phone Number: 844-663-3742; Email: abbvieclinicaltrials@abbvie.com

Study Locations

• United States
  • Illinois
    • Grayslake, Illinois, United States, 60030
      • Recruiting
      • Acpru /Id# 270279

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

12

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Group 1; Participants will receive a single dose of either ABBV-722 Dose A or placebo.	Drug: Placebo; Oral Capsule; Drug: ABBV-722; Oral Capsule
Experimental: Part 1: Group 2; Participants will receive a single dose of either ABBV-722 Dose B or placebo.	Drug: Placebo; Oral Capsule; Drug: ABBV-722; Oral Capsule
Experimental: Part 1: Group 3; Participants will receive a single dose of either ABBV-722 Dose C or placebo.	Drug: Placebo; Oral Capsule; Drug: ABBV-722; Oral Capsule
Experimental: Part 1: Group 4; Participants will receive a single dose of either ABBV-722 Dose TBD or placebo.	Drug: Placebo; Oral Capsule; Drug: ABBV-722; Oral Capsule
Experimental: Part 1: Group 5; Participants will receive a single dose of either ABBV-722 Dose TBD or placebo.	Drug: Placebo; Oral Capsule; Drug: ABBV-722; Oral Capsule
Experimental: Part 2: Group 6; Participants who are Han Chinese will receive a single dose of ABBV-722 Dose D.	Drug: ABBV-722; Oral Capsule
Experimental: Part 2: Group 7; Participants who are Japanese will receive a single dose of ABBV-722 Dose D.	Drug: ABBV-722; Oral Capsule
Experimental: Part 3: Group 8; Participants will receive either ABBV-722 Dose E or placebo for 14 days.	Drug: Placebo; Oral Capsule; Drug: ABBV-722; Oral Capsule
Experimental: Part 3: Group 9; Participants will receive either ABBV-722 Dose F or placebo for 14 days.	Drug: Placebo; Oral Capsule; Drug: ABBV-722; Oral Capsule
Experimental: Part 3: Group 10; Participants will receive either ABBV-722 Dose A or placebo for 14 days.	Drug: Placebo; Oral Capsule; Drug: ABBV-722; Oral Capsule
Experimental: Part 3: Group 11; Participants will receive either ABBV-722 Dose G or placebo for 14 days.	Drug: Placebo; Oral Capsule; Drug: ABBV-722; Oral Capsule
Experimental: Part 3: Group 12; Participants will receive either ABBV-722 Dose TBD or placebo for 14 days.	Drug: Placebo; Oral Capsule; Drug: ABBV-722; Oral Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with Adverse Events Reported During Safety Evaluations	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.	Up to Day 44
Maximum Plasma Concentration (Cmax) of ABBV-722	Cmax of ABBV-722.	Up to Day 21
For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Time t (AUCt) of ABBV-722	AUCt of ABBV-722.	Up to Day 8
For Part 3: Observed Plasma Concentration at the End of the Dosing Interval (Ctrough) of ABBV-722	Ctrough of ABBV-722.	Up to Day 21
For Part 3: AUC from Time 0 to the End of Dosing Interval (AUCtau) Following the First and Last Doses of ABBV-722	AUC from AUCtau following the first and last doses of ABBV-722.	Up to Day 21
Terminal Phase Elimination Rate Constant (Beta) of ABBV-722	Beta of ABBV-722.	Up to Day 21
Terminal Phase Elimination Half-Life (t1/2) of ABBV-722	t1/2 of ABBV-722.	Up to Day 21
Dose Normalized Cmax	Dose normalized Cmax.	Up to Day 21
Dose Normalized AUCs	Dose normalized AUCs.	Up to Day 21
Time to Cmax (Tmax) of ABBV-722	Tmax of ABBV-722.	Up to Day 21
For Parts 1 and 2: Area Under the Concentration-Time Curve (AUC) from Time 0 to Infinity (AUCinf) of ABBV-722	AUCinf of ABBV-722	Up to Day 8

Collaborators and Investigators

• Sponsor: AbbVie
• Investigators: Study Director: ABBVIE INC., AbbVie

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: October 29, 2024
• First Submitted That Met QC Criteria: November 1, 2024
• First Posted (Actual): November 4, 2024

Study Record Updates

• Last Update Posted (Actual): July 20, 2025
• Last Update Submitted That Met QC Criteria: July 17, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Healthy Volunteer; ABBV-722
• Other Study ID Numbers: M25-150

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No