A Study to Assess Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Participants

AbbVie

Status and phase: Terminated; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo for ABBV-903; Drug: ABBV-903

Study type: Interventional

Funder types: Industry

Identifiers

NCT06009237

M24-227

Details and patient eligibility

About

The objective of this study is to assess the pharmacokinetics (PK), safety, and tolerability of ABBV-903 or placebo in healthy adult Japanese and Han Chinese subjects.

Enrollment: 24 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy Japanese or Han Chinese male or female; age is between 18 and 65 years, inclusive at the time of screening.

• Han Chinese subject must be first-generation Han Chinese of full Chinese parentage residing outside of China. Subjects must maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.

OR

• Japanese subject must be first- or second generation Japanese of full Japanese parentage. First-generation subjects will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation subjects born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. All subjects must maintain a typical Japanese lifestyle, including consuming a typical Japanese diet.

  • Body Mass Index (BMI) is >= 18.0 to <= 30.0 kg/m2 after rounding to the tenths decimal, at screening and upon initial confinement. BMI is calculated as weight in kg divided by the square of height measured in meters.

Exclusion criteria

• History of any clinically significant illness/infection/major febrile illness, hospitalization, as determined by the investigator, or any surgical procedure within 30 days prior to the first dose of study drug.
• Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma orlocalized carcinoma in situ of the cervix.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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24 participants in 5 patient groups

Part 1: Han-Chinese Participants ABBV-903

Experimental group

Description:

Han-Chinese participants will receive a single dose of ABBV-903.

Treatment:

Drug: ABBV-903

Part 1: Japanese Participants ABBV-903

Experimental group

Description:

Japanese participants will receive a single dose of ABBV-903.

Treatment:

Drug: ABBV-903

Part 1: Placebo

Experimental group

Description:

Participants will receive a single dose of Placebo for ABBV-903.

Treatment:

Drug: Placebo for ABBV-903

Part 2: Japanese Participants ABBV-903

Experimental group

Description:

Japanese participants will receive ABBV-903 daily for 10 days.

Treatment:

Drug: ABBV-903

Part 2: Japanese Participants Placebo

Experimental group

Description:

Japanese participants will receive placebo daily for 10 days.

Treatment:

Drug: Placebo for ABBV-903