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

• Sponsor: MingSight Pharmaceuticals Pty Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02406989
• Collaborator: (none)
• Enrollment: 32
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 6.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Safety and PK in Healthy Volunteers	Drug: MS-553; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 32 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Multiple-Ascending Dose Study of MS-553 in Healthy Volunteers
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Number of Subjects with Adverse Events as a Measure of Safety and Tolerability [14 days]

Secondary Outcome Measures

1. Peak Plasma Concentration (Cmax) [14 days]

2. Area under the Plasma Concentration versus Time Area under the Plasma Concentration versus Time Curve [14 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nucleus Network	Melbourne	Victoria	Australia	3122

Sponsors and Collaborators

• MingSight Pharmaceuticals Pty Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MingSight Pharmaceuticals Pty Limited
• ClinicalTrials.gov Identifier: NCT02406989
• Other Study ID Numbers: MS-553-102
• First Posted: Apr 2, 2015
• Last Update Posted: Mar 16, 2016
• Last Verified: Mar 1, 2016

Study Results

No Results Posted as of Mar 16, 2016