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

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

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.

Study Overview

• Status: Terminated
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: ABBV-903; Drug: Placebo for ABBV-903

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801-2658
      • Anaheim Clinical Trials LLC /ID# 257033

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Han-Chinese Participants ABBV-903; Han-Chinese participants will receive a single dose of ABBV-903.	Drug: ABBV-903; Tablet; oral
Experimental: Part 1: Japanese Participants ABBV-903; Japanese participants will receive a single dose of ABBV-903.	Drug: ABBV-903; Tablet; oral
Experimental: Part 1: Placebo; Participants will receive a single dose of Placebo for ABBV-903.	Drug: Placebo for ABBV-903; Tablet; oral
Experimental: Part 2: Japanese Participants ABBV-903; Japanese participants will receive ABBV-903 daily for 10 days.	Drug: ABBV-903; Tablet; oral
Experimental: Part 2: Japanese Participants Placebo; Japanese participants will receive placebo daily for 10 days.	Drug: Placebo for ABBV-903; Tablet; oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum observed plasma concentration (Cmax) of ABBV-903	Cmax of ABBV-903 will be assessed.	Up to Day 4
Time to Cmax (Tmax) of ABBV-903	Tmax of ABBV-903 will be assessed.	Up to Day 4
Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-903	Apparent terminal phase elimination rate constant (β) of ABBV-903 will be assessed.	Up to Day 4
Terminal Phase Elimination Half-life (t1/2) of ABBV-903	Terminal phase elimination half-life (t1/2) of ABBV-903 will be assessed.	Up to Day 4
Area under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time t (AUC0-t) of ABBV-903	AUC0-t of ABBV-903 will be assessed.	Up to Day 4
AUC from Time 0 to Infinity (AUC0-inf) of ABBV-903	AUC0-inf of ABBV-903 will be assessed.	Up to Day 4
Number of Participants with Adverse Events (AEs)	An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.	Baseline to Day 34

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2023
• Primary Completion (Actual): October 30, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: August 21, 2023
• First Submitted That Met QC Criteria: August 21, 2023
• First Posted (Actual): August 24, 2023

Study Record Updates

• Last Update Posted (Estimated): November 13, 2023
• Last Update Submitted That Met QC Criteria: November 9, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Healthy Volunteers; ABBV-903
• Other Study ID Numbers: M24-227

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