Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316
NCT ID: NCT02041221
Last Updated: 2016-05-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
64 participants
INTERVENTIONAL
2014-01-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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SPARC1316 Dose 1
Subjects will be administered with SPARC1316 dose 1
SPARC1316 Dose 1
The subjects will receive SPARC1316.
Placebo
The subjects will receive placebo.
Placebo
SPARC1316 Dose 2
Subjects will be administered with SPARC1316 dose 2
SPARC1316 Dose 2
SPARC1316 Dose 3
Subjects will be administered with SPARC1316 dose 3
SPARC1316 Dose 3
SPARC1316 Dose 4
Subjects will be administered with SPARC1316 dose 4
SPARC1316 Dose 4
SPARC1316 Dose 5
Subjects will be administered with SPARC1316 dose 5
SPARC1316 Dose 5
Interventions
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SPARC1316 Dose 1
The subjects will receive SPARC1316.
Placebo
SPARC1316 Dose 2
SPARC1316 Dose 3
SPARC1316 Dose 4
SPARC1316 Dose 5
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Male or female subjects aged 18 to 65 years inclusive
* Body mass index (BMI) between 18.0 and 30.0 kg/m2 inclusive
* Non-smokers or ex-smokers
Exclusion Criteria
* Subjects who have a significant infection or known inflammatory process on screening or admission.
* Subjects who are unlikely to co-operate with the requirements of the study.
* Positive serology for infectious disease (hepatitisB or C , HIV) at screening
18 Years
65 Years
ALL
Yes
Sponsors
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Sun Pharma Advanced Research Company Limited
INDUSTRY
Responsible Party
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Locations
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SPARC study site
London, London, United Kingdom
Countries
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Other Identifiers
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SPARC_Ltd_ CLR_13_16
Identifier Type: -
Identifier Source: org_study_id
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