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A Study of OsrHSA in Adult Healthy Male and Female Volunteers

NCT04384523 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2021-06-01

Study results available
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Summary

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

Conditions

  • Ascites Hepatic

Interventions

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)

Sponsors & Collaborators

  • Healthgen Biotechnology Corp.

    lead INDUSTRY

Principal Investigators

  • David Nguyen, MD, MBA · WCCT Global, Inc

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-04
Primary Completion
2020-03-17
Completion
2020-07-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04384523 on ClinicalTrials.gov