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A Study Designed to Evaluate the Safety and Pharmacokinetics of Intravenously Administered Superoxide Dismutase Mimetic GC4711 in Healthy Volunteers

NCT03762031 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2020-08-14

No results posted yet for this study

Summary

The study will be a Phase 1, randomized, double-blind, placebo-controlled, single dose escalation study designed to evaluate the safety and PK of intravenously administered superoxide dismutase mimetic GC4711 in healthy volunteers.

Conditions

  • Healthy

Interventions

DRUG

GC4711 30mg

single dose given via a 15 minute intravenous infusion

DRUG

GC4711 60mg

single dose given via a 15 minute intravenous infusion

DRUG

GC4711 90mg

single dose given via a 15 minute intravenous infusion

DRUG

GC4711 120mg

single dose given via a 15 minute intravenous infusion

DRUG

Placebo

single dose of normal saline given via a 15 minute intravenous infusion

DRUG

GC4711 75mg

single dose given via a 15 minute intravenous infusion

DRUG

GC4711 105mg

single dose given via a 15 minute intravenous infusion

Sponsors & Collaborators

  • Galera Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Jon Holmlund, MD · Galera Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2019-03-19
Primary Completion
2020-03-04
Completion
2020-03-04

Countries

  • Australia

Study Locations

More Related Trials

Entities

Drugs

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 NCT03762031 on ClinicalTrials.gov