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OpenTrials
Completed

NCT Number: NCT02406989

A 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.

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Key information

Conditions

Safety and PK in Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network

Melbourne, Victoria, 3122, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MS-553

Drug

Study Drug

Placebo

Drug

Matching placebo to MS-553

Primary outcomes

  1. Number of Subjects with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 14 days

Secondary outcomes

  1. Peak Plasma Concentration (Cmax)

    Time frame: 14 days

  2. Area under the Plasma Concentration versus Time Area under the Plasma Concentration versus Time Curve

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

MingSight Pharmaceuticals Pty Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Apr 2, 2015
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.