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NCT04709913 · ClinicalTrials.gov registry record · Phase 1
Multiple Ascending Dose Study of HU6 in High BMI Volunteers
A Phase 1 study, sponsored by Rivus Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT04709913 is a Phase 1 study that has completed, run by Rivus Pharmaceuticals. The registered enrollment target is 30 participants.
The verdict
NCT04709913, a Phase 1 study, has completed, sponsored by Rivus Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study 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.
Interventions
- DRUG HU6
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2021-01-04 |
| Est. Completion | 2021-07-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04709913
The ClinicalTrials.gov registry entry for NCT04709913 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rivus Pharmaceuticals, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which HU6 is the first listed.
NCT04709913 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04709913 about?
NCT04709913 is a clinical study titled "Multiple Ascending Dose Study of HU6 in High BMI Volunteers". 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...
What is the current status of trial NCT04709913?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2021-01-04. Estimated completion is 2021-07-30.
What interventions are being tested in trial NCT04709913?
The interventions under investigation include: HU6 (DRUG).
Who is sponsoring clinical trial NCT04709913?
This trial is sponsored by Rivus Pharmaceuticals, which has 10 total clinical trials registered on ClinicalTrials.gov.
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