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Safety Study of NNZ-2566 in Healthy Female Subjects

NCT00961779 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2014-10-07

No results posted yet for this study

Summary

The purpose of this study is to obtain evidence of the safety of NNZ-2566 in healthy female volunteers and to determine the pharmacokinetics (PK) of NNZ-2566 in healthy female volunteers.

Conditions

  • Brain Injuries, Traumatic

Interventions

DRUG

NNZ-2566

Glycyl-L-2-Methylprolyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) for reconstitution with bicarbonate buffer and normal saline.

DRUG

Placebo

Normal saline infusion

Sponsors & Collaborators

  • Neuren Pharmaceuticals Limited

    lead INDUSTRY

Principal Investigators

  • Douglas J Wilson, MB ChB, PhD · Neuren Pharmaceuticals Ltd

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-08-31
Completion
2010-09-30

Countries

  • Australia

Study Locations

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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 NCT00961779 on ClinicalTrials.gov