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Study of OsrhAAT or Placebo in Healthy Volunteers

NCT05315921 ↗

Phase 1 Unknown 48 enrolled Healthgen Biotechnology Corp.
RandomizedSequentialDouble-blindOther

Summary

A Phase 1, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Single Ascending Doses of OsrhAAT in Healthy Volunteers

Timeline

Start
2022-03-22
Primary completion
2023-03-31
Completion
2023-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject OsrhAAT Unknown 1 mg/kg Intravenous
Subject OsrhAAT Unknown 3 mg/kg Intravenous
Subject OsrhAAT Unknown 10 mg/kg Intravenous
Subject OsrhAAT Unknown 20 mg/kg Intravenous
Subject OsrhAAT Unknown 40 mg/kg Intravenous
Subject OsrhAAT Unknown 60 mg/kg Intravenous

Indications

alpha 1-antitrypsin deficiency