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

Phase 1

Completed

• Conditions: Safety and PK in Healthy Volunteers
• Interventions: Drug: Placebo; Drug: MS-553

• Registration Number: NCT02406989
• Lead Sponsor: MingSight Pharmaceuticals Pty Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-25
• Study First Submitted QC: 2015-03-30
• Study Start: 2015-04
• Study First Posted: 2015-04-02
• Primary Completion: 2015-08
• Study Completion: 2015-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-14
• Last Update Posted: 2016-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo oral tablet BID x 14 days
MS-553	MS-553	MS-553 oral tablet BID x 14 days

Primary Outcome Measures

Name	Time	Method
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability	14 days

Secondary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax)	14 days
Area under the Plasma Concentration versus Time Area under the Plasma Concentration versus Time Curve	14 days

Trial Locations

Locations (1)

Nucleus Network; 🇦🇺 Melbourne, Victoria, Australia