A Double-blind, Placebo-controlled, Phase I Study of the Safety and Pharmacokinetics of Single Ascending Doses of HU6 in Healthy Volunteers
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Rivus Pharmaceuticals, Inc.
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- Assess the dose relationship of PK Parameter Cmax
Study Overview
Brief Summary
This is a single ascending dose trial in healthy volunteers. The study will be conducted in up to 7 cohorts. Upon review of the safety and PK data, it may be decided to expand the current cohort versus dose escalate to the next cohort. In addition, the sponsor may elect not to enroll all 7 cohorts based on safety and/or PK and/or PD data.
Detailed Description
This is a single ascending dose trial in healthy volunteers. The study will be conducted in up to 7 cohorts. Upon review of the safety and PK data, it may be decided to expand the current cohort versus dose escalate to the next cohort. In addition, the sponsor may elect not to enroll all 7 cohorts based on safety and/or PK and/or PD data.
Up to 74 subjects will be enrolled to allow for replacement subjects, if deemed necessary. Fewer subjects may be enrolled if not all cohorts are utilized due to identification of the MTD in an earlier cohort.
Double-blind dosing will occur in cohorts 1 through 7. In these cohorts, 6 subjects will receive HU6 and 2 will receive matching placebo.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Active Treatment: HU6
Planned doses of HU6; N = 74
Intervention: HU6 (Drug)
Placebo Comparator
Non-active study drug N = 14
Intervention: HU6 (Drug)
Outcomes
Primary Outcomes
Assess the dose relationship of PK Parameter Cmax
Time Frame: 3 months
Following completion of each cohort, bioanalytical analyses for HU6, PK will be performed and plasma PK parameters for Cmax analyzed
Assess the dose relationship of PK Parameter AUC
Time Frame: 3 months
Following completion of each cohort, bioanalytical analyses for HU6, PK will be performed and plasma PK parameters for AUC analyzed
Secondary Outcomes
No secondary outcomes reported