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

AbbVie

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: ABBV-722; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06673238

M25-150

Details and patient eligibility

About

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.

Enrollment: 96 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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96 participants in 12 patient groups

Part 1: Group 1

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABBV-722

Part 1: Group 2

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABBV-722

Part 1: Group 3

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABBV-722

Part 1: Group 4

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABBV-722

Part 1: Group 5

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABBV-722

Part 2: Group 6

Experimental group

Description:

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

Treatment:

Drug: ABBV-722

Part 2: Group 7

Experimental group

Description:

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

Treatment:

Drug: ABBV-722

Part 3: Group 8

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABBV-722

Part 3: Group 9

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABBV-722

Part 3: Group 10

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABBV-722

Part 3: Group 11

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABBV-722

Part 3: Group 12

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: ABBV-722