CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 41 enrolled
Drug / intervention
OsrHSA 20 mg/kg IV +5 moredrug
Likely dose
OsrHSA 20 mg/kg IVfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04384523
NCT04384523Phase 1Completed
CompareCT.gov

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

Healthgen Biotechnology Corp.·interventional·Posted May 12, 2020·Updated Jun 1, 2021

In Brief

A Phase 1 clinical trial evaluating OsrHSA 20 mg/kg IV, OsrHSA 40 mg/kg IV, and 4 other interventions for Ascites Hepatic. Completed, enrolled 41 participants across 1 site.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAscites Hepatic
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedMay 12, 2020
Enrollment StartNov 4, 2019
Primary CompletionMar 17, 2020
Study CompletionJul 13, 2020
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 6.1 years ago

Interventions

OsrHSA 20 mg/kg IVdrug

A single dose of OsrHSA 20 mg/kg IV infusion at a rate lower than 2 ml/min

OsrHSA 40 mg/kg IVdrug

A single dose of OsrHSA 40 mg/kg IV infusion at a rate lower than 2 ml/min

OsrHSA 80 mg/kg IVdrug

A single dose of OsrHSA 80 mg/kg IV infusion at a rate lower than 2 ml/min

OsrHSA 140 mg/kg IVdrug

A single dose of OsrHSA 140 mg/kg IV infusion at a rate lower than 2 ml/min

OsrHSA 200 mg/kg IVdrug

A single dose of OsrHSA 200 mg/kg IV infusion at a rate lower than 2 ml/min

Placeboother

Normal Saline (0.9% Sodium Chloride)