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

NCT04505137 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2021-09-01

No results posted yet for this study

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Metaclinical

    collaborator UNKNOWN

  • Syneos Heath

    collaborator UNKNOWN

  • Gmax Biopharm Australia Pty Ltd.

    lead INDUSTRY

Principal Investigators

  • Sepehr Shakib, Dr · CMAX Clinical Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-09-02
Primary Completion
2021-03-19
Completion
2021-03-19

Countries

  • Australia

Study Locations

More Related Trials

Entities

Diseases

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 NCT04505137 on ClinicalTrials.gov