Study Investigating the Safety, Tolerability, and PK, PD, of CB-0406
NCT04467684 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 90
Last updated 2021-06-11
Summary
The study is designed as a single center, randomized, double-blind, placebo-controlled study to assess the PK, safety, tolerability and PD of CB-0406 in healthy participants. The study will be conducted as a 2-part study.
Conditions
- Healthy Volunteers
Interventions
- DRUG
-
CB-0406 100 mg
Single oral dose
- DRUG
-
CB-0406 200 mg
Single oral dose
- DRUG
-
CB-0406 400 mg
Single oral dose
- DRUG
-
CB-0406 800 mg
Single oral dose
- DRUG
-
CB-0406 1,000 mg
Single oral dose
- DRUG
-
Matched placebo
Color and size matched placebo
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Elaine Watkins, DO, MSPH · Gilead Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-07-07
- Primary Completion
- 2021-05-30
- Completion
- 2021-06-06
Countries
- Australia
Study Locations
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