drugset / Trial / NCT04737486
A First-in-Human Study of AV-001 in Healthy Subjects
RandomizedSequentialQuadruple-blindTreatment
Summary
Phase 1 randomized, double-blind, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) first-in-human study in healthy subjects. Safety and tolerability assessments will be conducted, and blood samples will be taken pre-dose and at several time points post-dose for pharmacokinetic (PK) and pharmacodynamics (PD) analysis.
Timeline
- Start
- 2020-12-16
- Primary completion
- 2021-03-10
- Completion
- 2021-03-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AV-001 | Unknown | 1.4 ug/kg | Intravenous |
| Subject | AV-001 | Unknown | 56 ug/kg | Intravenous |