NCT04384523

A Study of OsrHSA in Adult Healthy Male and Female Volunteers

A Phase 1 Randomized, Double Blinded, Placebo-Controlled Single Dose Escalation Study of OsrHSA in Adult Healthy Male and Female Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Healthgen Biotechnology Corp. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

A Phase 1 randomized, double blinded, placebo-controlled single dose escalation study of OsrHSA in adult healthy male and female volunteers

Detailed description

This is a Phase 1 randomized, double blinded, placebo-controlled, single dose escalation study to evaluate safety, tolerability, PK, and immunogenicity of OsrHSA in healthy volunteers.

Conditions

• Ascites Hepatic

Interventions

Type	Name	Description
DRUG	OsrHSA 20 mg/kg IV	A single dose of OsrHSA 20 mg/kg IV infusion at a rate lower than 2 ml/min
DRUG	OsrHSA 40 mg/kg IV	A single dose of OsrHSA 40 mg/kg IV infusion at a rate lower than 2 ml/min
DRUG	OsrHSA 80 mg/kg IV	A single dose of OsrHSA 80 mg/kg IV infusion at a rate lower than 2 ml/min
DRUG	OsrHSA 140 mg/kg IV	A single dose of OsrHSA 140 mg/kg IV infusion at a rate lower than 2 ml/min
DRUG	OsrHSA 200 mg/kg IV	A single dose of OsrHSA 200 mg/kg IV infusion at a rate lower than 2 ml/min
OTHER	Placebo	Normal Saline (0.9% Sodium Chloride)

Timeline

• Start date: 2019-11-04
• Primary completion: 2020-03-17
• Completion: 2020-07-13
• First posted: 2020-05-12
• Last updated: 2021-06-01
• Results posted: 2021-06-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study