A Multiple-Ascending Dose Study of MS-553 in Healthy Volunteers

March 14, 2016 updated by: MingSight Pharmaceuticals Pty Limited

A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Multiple-Ascending Dose Study of MS-553 in Healthy Volunteers

This is a randomized, double-blind, placebo-controlled, multiple-ascending dose study of MS-553 in healthy volunteers. Endpoints are safety, tolerability, and pharmacokinetics. Subjects are dosed for 14 days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3122
        • Nucleus Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • In good general health with BMI 18 to 32 kg/m2. Females must be nonpregnant, nonlactating, postmenopausal at least 2 years or surgically sterilized at least 6 months prior

Exclusion Criteria:

  • History of skin rash, migraine, or clinically significant ocular diseases, conditions predisposing to QT prolongation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MS-553
MS-553 oral tablet BID x 14 days
Drug: MS-553
Study Drug
Placebo Comparator: Placebo
Placebo oral tablet BID x 14 days
Drug: Placebo
Matching placebo to MS-553

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Peak Plasma Concentration (Cmax)
Time Frame: 14 days
14 days
Area under the Plasma Concentration versus Time Area under the Plasma Concentration versus Time Curve
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MingSight Pharmaceuticals Pty Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

March 25, 2015

First Submitted That Met QC Criteria

March 30, 2015

First Posted (Estimate)

April 2, 2015

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • MS-553-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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