NCT05315921

Study of OsrhAAT or Placebo in Healthy Volunteers

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Healthgen Biotechnology Corp. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Emphysema Secondary to Congenital AATD

Interventions

Type	Name	Description
DRUG	OsrhAAT 1 mg/kg IV	Drug: OsrhAAT 1 mg/kg IV A single dose of OsrhAAT 1 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg. Placebo: Normal Saline (0.9% Sodium Chloride)
DRUG	OsrhAAT 3 mg/kg IV	Drug: OsrhAAT 3 mg/kg IV A single dose of OsrhAAT 3 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg. Placebo: Normal Saline (0.9% Sodium Chloride)
DRUG	OsrhAAT 10 mg/kg IV	Drug: : OsrhAAT 10 mg/kg IV A single dose of OsrhAAT 10 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg. Placebo: Normal Saline (0.9% Sodium Chloride)
DRUG	OsrhAAT 20 mg/kg IV	Drug: OsrhAAT 20 mg/kg IV A single dose of OsrhAAT 20 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg. Placebo: Normal Saline (0.9% Sodium Chloride)
DRUG	OsrhAAT 40 mg/kg IV	Drug: OsrhAAT 40 mg/kg IV A single dose of OsrhAAT 40 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg. Placebo: Normal Saline (0.9% Sodium Chloride)
DRUG	OsrhAAT 60 mg/kg IV	Drug: OsrhAAT 60 mg/kg IV A single dose of OsrhAAT 60 mg/kg IV infusion at a rate approximately 0.04 ml/min/kg. Placebo: Normal Saline (0.9% Sodium Chloride)

Timeline

• Start date: 2022-03-22
• Primary completion: 2023-03-31
• Completion: 2023-06-30
• First posted: 2022-04-07
• Last updated: 2022-12-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study