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A Study to Determine the Safety, Tolerability and Pharmacokinetics of PMZ-2010 (Centhaquin) in Healthy Volunteers

NCT02408731 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2015-04-28

No results posted yet for this study

Summary

Shock is a condition of reduced tissue perfusion, resulting in the inadequate delivery of oxygen and nutrients that are necessary for cellular function. The current resuscitative agents can extend patient's life to a limited extent. Centhaquin (PMZ-2010) in very low doses reduced blood lactate levels, improved blood pressure, cardiac output, survival and proved to be a highly effective resuscitative agent. The investigators are conducting a phase I clinical study in humans to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of centhaquin citrate in normal healthy volunteers.

Conditions

  • Healthy

Interventions

DRUG

PMZ-2010 (Centhaquin)

As per the randomization schedule, injection of PMZ-2010 or placebo (100 ml normal saline) will be administered to each subject under supervision of investigator as an intravenous infusion over one hour. PMZ-2010 will be dissolved in normal saline (100 ml) before administration.

Sponsors & Collaborators

  • Pharmazz, Inc.

    lead INDUSTRY

Principal Investigators

  • Ashish O Goyal, MD · Jehangir Clinical Development Centre Pvt. Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • India

Study Locations

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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 NCT02408731 on ClinicalTrials.gov