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A Study of GFH312 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication (IC)

NCT05618691 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-09-06

No results posted yet for this study

Summary

GFH312 could be a novel therapeutic option in the acute/chronic inflammatory process of atherosclerosis and provides potential beneficial effects to microvasculature function for PAD patients with IC in addition to preventing ischemia-reperfusion injury. This phase II study is designed to explore the clinical safety and efficacy of GFH312 after multiple oral doses, to support further development in patients with PAD or other atherosclerotic diseases.

Conditions

Interventions

DRUG

GFH312

Oral tablet, GFH312 will be administered at 3 dose levels, each patient in one of three groups will be given a dose of 40mg, 80mg, 120mg of the study drug.

OTHER

Placebo

Placebo will be administered to subjects in the placebo group

Sponsors & Collaborators

  • Zhejiang Genfleet Therapeutics Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-12-01
Primary Completion
2023-12-31
Completion
2024-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05618691 on ClinicalTrials.gov