A Multiple Ascending Dose Phase I Study of DBPR108 in Healthy Male Subjects
NCT02163278 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2016-03-28
Summary
The study is being performed to assess the safety, tolerability, and pharmacokinetic (PK) and pharmacodynamic (PD) properties of multiple oral doses of DBPR108 in healthy male subjects.
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
DBPR108
DBPR108 capsules in four doses beginning at 25 mg and rising to 600 mg.
- DRUG
-
matching placebo
Matching placebo capsules in four doses beginning at 25 mg and rising to 600 mg.
Sponsors & Collaborators
-
National Health Research Institutes, Taiwan
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 45 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2014-06-30
- Primary Completion
- 2015-01-31
- Completion
- 2015-01-31
Countries
- Taiwan
Study Locations
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