drugset / Trial / NCT04415671

Phase 1 Safety, Tolerability, PK & PD Study of AD-214 Administered to Healthy Volunteers

NCT04415671

Phase 1 Completed 50 enrolled AdAlta Limited
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

EvaluationDrugModalityDoseRoute
Subject AD-214 Protein / enzyme biologic Intravenous