Phase 2
N=40
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT02041221 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcome: Primary: Number of Subjects With Adverse Events — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SPARC1316 Dose 1 (Drug); Placebo (Drug); SPARC1316 Dose 2 (Drug); SPARC1316 Dose 3 (Drug); SPARC1316 Dose 4 (Drug); SPARC1316 Dose 5 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Pharma Advanced Research Company Limited
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Adverse Events |
0; 0; 0; 0; 1; 2 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02041221). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.