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

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

Timeline

Start

2020-09-02

Primary completion

2021-03-19

Completion

2021-03-19

Drugs

Indications