NCT04505137

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Gmax Biopharm Australia Pty Ltd. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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

Detailed 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).

Conditions

• Pulmonary Arterial Hypertension

Interventions

Type	Name	Description
DRUG	GMA301 Injection	GMA301 Injection administered as a single dose of 1500 mg
OTHER	GMA301 Placebo Injection	GMA301 Injection without GMA301 administered as a single intravenous dose
DRUG	GMA301 Injection	GMA301 Injection administered as a single dose of 2000 mg

Timeline

• Start date: 2020-09-02
• Primary completion: 2021-03-19
• Completion: 2021-03-19
• First posted: 2020-08-10
• Last updated: 2021-09-01

Locations

1 site across 1 country: Australia