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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02406989




Registration number
NCT02406989
Ethics application status
Date submitted
25/03/2015
Date registered
2/04/2015
Date last updated
16/03/2016

Titles & IDs
Public title
A Multiple-Ascending Dose Study of MS-553 in Healthy Volunteers
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Phase 1, Multiple-Ascending Dose Study of MS-553 in Healthy Volunteers
Secondary ID [1] 0 0
MS-553-102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Safety and PK in Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MS-553
Treatment: Drugs - Placebo

Experimental: MS-553 - MS-553 oral tablet BID x 14 days

Placebo Comparator: Placebo - Placebo oral tablet BID x 14 days


Treatment: Drugs: MS-553
Study Drug

Treatment: Drugs: Placebo
Matching placebo to MS-553
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Subjects with Adverse Events as a Measure of Safety and Tolerability
Timepoint [1] 0 0
14 days
Secondary outcome [1] 0 0
Peak Plasma Concentration (Cmax)
Timepoint [1] 0 0
14 days
Secondary outcome [2] 0 0
Area under the Plasma Concentration versus Time Area under the Plasma Concentration versus Time Curve
Timepoint [2] 0 0
14 days

Eligibility
Key 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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of skin rash, migraine, or clinically significant ocular diseases, conditions
predisposing to QT prolongation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2015
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 0 0
3122 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
MingSight Pharmaceuticals Pty Limited
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02406989
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries