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

MingSight Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Safety and PK in Healthy Volunteers

Treatments: Drug: MS-553; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02406989

MS-553-102

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

32 participants in 2 patient groups, including a placebo group

MS-553

Experimental group

Description:

MS-553 oral tablet BID x 14 days

Treatment:

Drug: MS-553

Placebo

Placebo Comparator group

Description:

Placebo oral tablet BID x 14 days

Treatment:

Drug: Placebo