NCT04463017

Ascending Dose Study of HU6 in Healthy Volunteers

A Double-blind, Placebo-controlled, Phase I Study of the Safety and Pharmacokinetics of Single Ascending Doses of HU6 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Rivus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• NASH - Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	HU6	HU6 is designed to reduce the steatosis, inflammation, fibrosis and hepatocyte injury in Noncirrhotic Nonalcoholic Steatohepatitis (NASH)

Timeline

• Start date: 2020-08-12
• Primary completion: 2021-03-30
• Completion: 2021-04-01
• First posted: 2020-07-09
• Last updated: 2021-05-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study