drugset
drugset / Trial / NCT07256288

A Phase Ia Study of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of EA5 in Healthy Adult Subjects

NCT07256288 ↗

Phase 1 Completed 28 enrolled Shanghai Lanyi Therapeutics Co., Ltd.
RandomizedSequentialTriple-blindBasic science

Summary

This is a single-center, double-blind, placebo-controlled, dose-escalating Phase Ia clinical study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of a single dose of EA5 in healthy adult subjects.

Timeline

Start
2023-05-31
Primary completion
2024-08-01
Completion
2024-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject EA5 Monoclonal antibody 90 mg Intravenous
Subject EA5 Monoclonal antibody 180 mg Intravenous
Subject EA5 Monoclonal antibody 360 mg Intravenous
Subject EA5 Monoclonal antibody 720 mg Intravenous
Subject EA5 Monoclonal antibody 1440 mg Intravenous

Indications

No indication recorded.