Trials / Withdrawn
WithdrawnNCT05618691
A Study of GFH312 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication (IC)
A Double-blinded, Randomized, Placebo-controlled Study of GFH312 in Patients With Peripheral Artery Disease (PAD) and Intermittent Claudication (IC)
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Zhejiang Genfleet Therapeutics Co., Ltd. · Industry
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2022-12-01
- Primary completion
- 2023-12-31
- Completion
- 2024-05-31
- First posted
- 2022-11-16
- Last updated
- 2023-09-06
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05618691. Inclusion in this directory is not an endorsement.