Ascending Dose Study of HU6 in Healthy Volunteers

Phase 1

Completed

• Conditions: NASH - Nonalcoholic Steatohepatitis
• Interventions: Drug: HU6

• Registration Number: NCT04463017
• Lead Sponsor: Rivus Pharmaceuticals, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2020-07-03
• Study First Submitted QC: 2020-07-03
• Study First Posted: 2020-07-09
• Study Start: 2020-08-12
• Primary Completion: 2021-03-30
• Study Completion: 2021-04-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-02
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	HU6	Non-active study drug N = 14
Active Treatment: HU6	HU6	Planned doses of HU6; N = 74

Primary Outcome Measures

Name	Time	Method
Assess the dose relationship of PK Parameter Cmax	3 months	Following completion of each cohort, bioanalytical analyses for HU6, PK will be performed and plasma PK parameters for Cmax analyzed
Assess the dose relationship of PK Parameter AUC	3 months	Following completion of each cohort, bioanalytical analyses for HU6, PK will be performed and plasma PK parameters for AUC analyzed

Trial Locations

Locations (1)

Prism Clinical Research; 🇺🇸 Saint Paul, Minnesota, United States