Phase 2
Completed N=40
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316
Source: ClinicalTrials.gov NCT02041221 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Number of Subjects With Adverse Events — 0; 0; 0; 0 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Adverse Events |
0; 0; 0; 0; 1; 2 | — |
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. Informational only — not medical advice.