drugset / Trial / NCT05348772
A First-In-Human Phase 1b Study of AmnioPul-02 in COVID-19 / Other LRTI
Non-randomizedSequentialOpen-labelTreatment
Summary
This is a first-in-human (FIH), Phase 1b, open-label, dose-escalation, safety trial consisting of 3 dose levels. Subjects will always be treated in cohorts of size 3, with from 3 up to 6 cohorts i.e. 9-18 subjects.
Timeline
- Start
- 2022-10-10
- Primary completion
- 2023-02-09
- Completion
- 2023-02-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | AmnioPul-02 | Cell therapy | — | — |