drugset / Trial / NCT04415671
Phase 1 Safety, Tolerability, PK & PD Study of AD-214 Administered to Healthy Volunteers
RandomizedSequentialQuadruple-blindTreatment
Summary
This is a first in human (FIH), multi-center, dose escalating study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of AD-214 when administered to healthy volunteers (HVs). The study in HVs will be a randomized, double blind, and placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) (Part B) study.
Timeline
- Start
- 2020-06-19
- Primary completion
- 2021-10-21
- Completion
- 2022-02-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AD-214 | Protein / enzyme biologic | — | Intravenous |