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

NCT ID: NCT02406989

Last Updated: 2016-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Safety and PK in Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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MS-553

MS-553 oral tablet BID x 14 days

Group Type EXPERIMENTAL

MS-553

Intervention Type DRUG

Study Drug

Placebo

Placebo oral tablet BID x 14 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo to MS-553

Interventions

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MS-553

Study Drug

Intervention Type DRUG

Placebo

Matching placebo to MS-553

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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MingSight Pharmaceuticals Pty Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nucleus Network

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Other Identifiers

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MS-553-102

Identifier Type: -

Identifier Source: org_study_id

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