drugset / Trial / NCT05170737
AEF0217 First-in-Human Phase I Study in 3 Parts (Single and Multiple Ascending Doses, and Food Effect) in Healthy Subjects.
RandomizedSequentialQuadruple-blindTreatment
Summary
This trial is divided in 3 parts: FIH-SAD (Single Ascending Doses), FIH-MAD (Multiple Ascending Doses) and FIH-FE (Food effects). FIH-SAD will start first. The start of FIH-MAD will await the results of at least three cohorts from the FIHSAD study before initiated. The starting dose of the FIH-MAD will have been shown to be well tolerated and one dose level lower than the highest dose for which safety, tolerability and pharmacokinetic (PK) data are available. FIH-FE will be the last to start after the completion of FIH-SAD and conducted in parallel with parts of FIH-MAD.
Timeline
- Start
- 2021-10-01
- Primary completion
- 2022-06-28
- Completion
- 2022-06-28
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AEF0217 | Unknown | 0.2 mg | Oral |
| Subject | AEF0217 | Unknown | 0.6 mg | Oral |
| Subject | AEF0217 | Unknown | 2 mg | Oral |
| Subject | AEF0217 | Unknown | 6 mg | Oral |
Indications
No indication recorded.