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A Phase 1b Study of the Safety of REN001 in Patients With Fatty Acid Oxidation Disorders

NCT03833128 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-12-09

No results posted yet for this study

Summary

The purpose of this Phase 1b study is to assess REN001 safety in subjects with fatty acid oxidation disorders.

Conditions

  • Fatty Acid Oxidation Disorders

Interventions

DRUG

Low Dose REN001

Oral

DRUG

High Dose REN001

Oral

Sponsors & Collaborators

  • Reneo Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Jerry Vockley, M.D., Ph.D. · University of Pittsburgh Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-04
Primary Completion
2022-01-24
Completion
2022-03-21
FDA Drug
Yes

Countries

  • United States
  • France
  • Spain

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 NCT03833128 on ClinicalTrials.gov