Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316

Study Overview
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Brief Summary
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Sun Pharma Advanced Research company Limited has developed a dry powder inhaler of compound SPARC1316 for oral inhalation. This clinical study is a Phase I/IIa study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of S0597 administered by oral inhalation to healthy volunteers and asthma patients.

Conditions
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Asthma

Intervention / Treatment
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* Drug: SPARC1316 Dose 1
* Drug: Placebo
* Drug: SPARC1316 Dose 2
* Drug: SPARC1316 Dose 3
* Drug: SPARC1316 Dose 4
* Drug: SPARC1316 Dose 5


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects willing to provide informed consent 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 with a supine systolic blood pressure ≥160 mmHg and/or a supine diastolic blood pressure ≥100 mmHg 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPARC1316 Dose 1<br>Subjects will be administered with SPARC1316 dose 1 | Drug: SPARC1316 Dose 1<br>* The subjects will receive SPARC1316.<br>|
| Placebo Comparator: Placebo<br>The subjects will receive placebo. | Drug: Placebo<br> <br> * Other names: The subjects will receive a matching placebo by oral inhalation.;|
| Experimental: SPARC1316 Dose 2<br>Subjects will be administered with SPARC1316 dose 2 | Drug: SPARC1316 Dose 2<br> <br> |
| Experimental: SPARC1316 Dose 3<br>Subjects will be administered with SPARC1316 dose 3 | Drug: SPARC1316 Dose 3<br> <br> |
| Experimental: SPARC1316 Dose 4<br>Subjects will be administered with SPARC1316 dose 4 | Drug: SPARC1316 Dose 4<br> <br> |
| Experimental: SPARC1316 Dose 5<br>Subjects will be administered with SPARC1316 dose 5 | Drug: SPARC1316 Dose 5<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Adverse Events | The no of adverse events will be assessed to evaluate the safety and tolerability of compound SO597 in healthy male subjects and asthma patients | Two (2) Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, pharmacodynamics, asthma