Status:
TERMINATED
A Study to Assess Pharmacokinetics, Safety, and Tolerability of ABBV-903 in Healthy Japanese and Han Chinese Participants
Lead Sponsor:
AbbVie
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- \- 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
- 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.
Key Trial Info
Start Date :
August 23 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06009237
Start Date
August 23 2023
End Date
October 30 2023
Last Update
November 13 2023
Active Locations (1)
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1
Anaheim Clinical Trials LLC /ID# 257033
Anaheim, California, United States, 92801-2658