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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02406989

Enrollment

Registered

2015-04-02

Start date

2015-04-30

Completion date

2015-09-30

Last updated

2016-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Safety and PK in Healthy Volunteers

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.

Interventions

DRUGMS-553

Study Drug

DRUGPlacebo

Matching placebo to MS-553

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Peak Plasma Concentration (Cmax)	14 days
Area under the Plasma Concentration versus Time Area under the Plasma Concentration versus Time Curve	14 days

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026