drugset / Trial / NCT04709913
Multiple Ascending Dose Study of HU6 in High BMI Volunteers
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | HU6 | Unknown | — | — |