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A Study to Investigate Safe and Tolerable Dose of GMA301 Injection in Healthy Volunteers

Pulmonary Arterial Hypertension Clinical Trial

Official title:
A Phase 1, Placebo-Controlled, Double-Blind, Dose-Escalation Study To Investigate The Safety, Tolerability, And Pharmacokinetics Of A Single Intravenous Dose Of GMA301 Injection In Healthy Volunteers

Clinical Trial Summary

This study is a single-centre, randomized, double-blind, placebo-controlled, dose escalation study to assess the safety, tolerability and PK of GMA301 Injection in healthy subjects. Two sequential dosing cohorts (at ascending dose fashion), each with 6 subjects receiving GMA301 Injection and 2 subjects receiving placebo (total of 16 subjects), will be given single doses. The doses to be administered in the two cohorts will be 1500 mg and 2000 mg respectively, or matching placebo

Clinical Trial Description

The current study is an extension of the previous study #1010218 (ACTRN12618000121268) to further explore the safety and PK profile of GMA301 injection at higher dosage. The SRC (Safety Review Committee) will be responsible for the assessment of safety, tolerability, and PK data for each dose level and to make decisions with regards to study progression. A Statistical Analysis Plan (SAP) will be written after finalizing the protocol and prior to database lock. The SAP will detail the implementation of all the planned statistical analyses in accordance with the principal features stated in the protocol. Adverse events will be coded using the Medical Dictionary for Regulatory Activities (MedDRA). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04505137
Study type Interventional
Source Gmax Biopharm LLC.
Contact
Status Completed
Phase Phase 1
Start date September 2, 2020
Completion date March 19, 2021
View Details
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