Multiple Ascending Dose Study of HU6 in High BMI Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- 40
Summary
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: The study will be conducted in one phase: a single dose, dose escalation phase in up to 4 cohortsMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 45 years
- Gender
- Both males and females
Description
This is a 14-day multiple ascending dose trial in high BMI volunteers in up to 4 cohorts of 10 high BMI volunteers each consisting of 8 receiving HU6 and 2 receiving placebo. Upon review of the safety and PK data, it may be decided to expand the current cohort size and/or dose escalate to the next c...
This is a 14-day multiple ascending dose trial in high BMI volunteers in up to 4 cohorts of 10 high BMI volunteers each consisting of 8 receiving HU6 and 2 receiving placebo. Upon review of the safety and PK data, it may be decided to expand the current cohort size and/or dose escalate to the next cohort. In addition, the sponsor may elect not to enroll all 4 cohorts based on safety and/or PK and/or PD data, or enlist an additional cohort at a higher dose if deemed safe. Double-blind dosing will occur in cohorts 1 through 4. In these cohorts, 8 subjects will receive HU6 and 2 will receive matching placebo. Doses will escalate and may be modified based on results of safety and pharmacokinetic evaluation conducted after each cohort.
Tracking Information
- NCT #
- NCT04709913
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Amy Eastenson, MD Prism Research Clinic
Get Well Soon