drugset / Trial / NCT04709913

Multiple Ascending Dose Study of HU6 in High BMI Volunteers

NCT04709913 ↗

Phase 1 Completed 30 enrolled Rivus Pharmaceuticals, Inc.
RandomizedSequentialQuadruple-blindTreatment

Summary

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.

Timeline

Start
2021-01-04
Primary completion
2021-04-30
Completion
2021-07-30

Drugs

EvaluationDrugModalityDoseRoute
Comparator HU6 Unknown — —