drugset / Trial / NCT04541550
Allogeneic Micronized Amniotic Membrane Product for the Treatment of Hidradenitis Suppurativa
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This study is an open-label, dose-escalation study enrolling 15 participants. There are 3 cohorts: 1. Cohort I: 5 subjects each receiving 1 injection of IGN-AMP001 (12.5mg AMP-001 in 3ml Saline) 2. Cohort II: 5 subjects each receiving 1 injection of IGN-AMP001 (25 mg AMP-001 in 3 ml Saline) 3. Cohort III: 5 subjects each receiving 1 injection of IGN-AMP001 (50 mg AMP-001 in 3 ml Saline).
Timeline
- Start
- 2021-04-01
- Primary completion
- 2021-07-01
- Completion
- 2021-07-01
Outcome
Outcome not reported
Stopped: “Study didn't proceed to FDA submission”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AMP-001 | Unknown | 12.5 mg | Other |
| Subject | AMP-001 | Unknown | 25 mg | Other |
| Subject | AMP-001 | Unknown | 50 mg | Other |