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Ascending Dose Study of HU6 in Healthy Volunteers

NCT04463017 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-05-04

No results posted yet for this study

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.

Conditions

  • NASH - Nonalcoholic Steatohepatitis

Interventions

DRUG

HU6

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

Sponsors & Collaborators

  • Rivus Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Mark Matson, MD · Prism Research Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-12
Primary Completion
2021-03-30
Completion
2021-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04463017 on ClinicalTrials.gov