A Study to Assess Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Participants
- Registration Number
- NCT06009237
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 24
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part 1: Placebo Placebo for ABBV-903 Participants will receive a single dose of Placebo for ABBV-903. Part 1: Japanese Participants ABBV-903 ABBV-903 Japanese participants will receive a single dose of ABBV-903. Part 2: Japanese Participants Placebo Placebo for ABBV-903 Japanese participants will receive placebo daily for 10 days. Part 2: Japanese Participants ABBV-903 ABBV-903 Japanese participants will receive ABBV-903 daily for 10 days. Part 1: Han-Chinese Participants ABBV-903 ABBV-903 Han-Chinese participants will receive a single dose of ABBV-903.
- Primary Outcome Measures
Name Time Method Maximum observed plasma concentration (Cmax) of ABBV-903 Up to Day 4 Cmax of ABBV-903 will be assessed.
Terminal Phase Elimination Half-life (t1/2) of ABBV-903 Up to Day 4 Terminal phase elimination half-life (t1/2) of ABBV-903 will be assessed.
Number of Participants with Adverse Events (AEs) Baseline to Day 34 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.
Area under the Plasma Concentration-time Curve (AUC) from Time 0 to the Time t (AUC0-t) of ABBV-903 Up to Day 4 AUC0-t of ABBV-903 will be assessed.
AUC from Time 0 to Infinity (AUC0-inf) of ABBV-903 Up to Day 4 AUC0-inf of ABBV-903 will be assessed.
Time to Cmax (Tmax) of ABBV-903 Up to Day 4 Tmax of ABBV-903 will be assessed.
Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-903 Up to Day 4 Apparent terminal phase elimination rate constant (β) of ABBV-903 will be assessed.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Anaheim Clinical Trials LLC /ID# 257033
🇺🇸Anaheim, California, United States