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

NCT06673238 | Recruiting Phase 1

• 1 other identifier: M25-150
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; ABBV-722

Outcome Measures

Primary Outcomes (11)

• 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

• 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 Time t (AUCt) of ABBV-722

  AUCt of ABBV-722.

  Up to Day 8

• 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

• 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

Study Arms (12)

Part 1: Group 1

EXPERIMENTAL

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

Drug: ABBV-722; Drug: Placebo

Part 1: Group 2

EXPERIMENTAL

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

Drug: ABBV-722; Drug: Placebo

Part 1: Group 3

EXPERIMENTAL

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

Drug: ABBV-722; Drug: Placebo

Part 1: Group 4

EXPERIMENTAL

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

Drug: ABBV-722; Drug: Placebo

Part 1: Group 5

EXPERIMENTAL

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

Drug: ABBV-722; Drug: Placebo

Part 2: Group 6

EXPERIMENTAL

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

Drug: ABBV-722

Part 2: Group 7

EXPERIMENTAL

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

Drug: ABBV-722

Part 3: Group 8

EXPERIMENTAL

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

Drug: ABBV-722; Drug: Placebo

Part 3: Group 9

EXPERIMENTAL

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

Drug: ABBV-722; Drug: Placebo

Part 3: Group 10

EXPERIMENTAL

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

Drug: ABBV-722; Drug: Placebo

Part 3: Group 11

EXPERIMENTAL

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

Drug: ABBV-722; Drug: Placebo

Part 3: Group 12

EXPERIMENTAL

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

Drug: ABBV-722; Drug: Placebo

Interventions

ABBV-722 DRUG

Oral Capsule

Part 1: Group 1; Part 1: Group 2; Part 1: Group 3; Part 1: Group 4; Part 1: Group 5; Part 2: Group 6; Part 2: Group 7; Part 3: Group 10; Part 3: Group 11; Part 3: Group 12; Part 3: Group 8; Part 3: Group 9

Placebo DRUG

Oral Capsule

Part 1: Group 1; Part 1: Group 2; Part 1: Group 3; Part 1: Group 4; Part 1: Group 5; Part 3: Group 10; Part 3: Group 11; Part 3: Group 12; Part 3: Group 8; Part 3: Group 9

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (1)

Acpru /Id# 270279

Grayslake, Illinois, 60030, United States

RECRUITING

Related Links

• Related Info

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

ABBVIE CALL CENTER

CONTACT

844-663-3742; abbvieclinicaltrials@abbvie.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: November 4, 2024
• Study Start: October 29, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)