Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ONO-2952 in Healthy Adult Subjects
Sponsored by Ono Pharma USA Inc
About this trial
Last updated 13 years ago
Study ID
ONO-2952POU001
Status
Completed
Type
Interventional
Phase
Phase 1
Placebo
Yes
Accepting
18 to 55 Years
All
Trial Timing
Started 14 years ago
What is this trial about?
The primary objective of this study is to evaluate the safety and tolerability of
ONO-2952 across ascending single doses in healthy adult male and female subjects. The
secondary objective is to characterize the pharmacokinetic (PK) profile of ONO-2952. The
tertiary objective of this study is to preliminarily evaluate the effect of a meal upon
the PK profile of ONO-2952.
What are the participation requirements?
Inclusion Criteria
- Healthy non-smoking male or female subjects (18-55 inclusive)
- Body mass index (BMI) of 19-35 kg/m2 (inclusive)
- For females, surgically sterilized, postmenopausal, or who are non- lactating and agree to use a double barrier method of contraception
Exclusion Criteria
- History or presence of clinically significant disease