Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: SPARC1316 Dose 5; Drug: SPARC1316 Dose 1; Drug: Placebo; Drug: SPARC1316 Dose 2; Drug: SPARC1316 Dose 3; Drug: SPARC1316 Dose 4

• Registration Number: NCT02041221
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-20
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Results First Submitted: 2015-12-14
• Results First Submitted QC: 2016-03-01
• Results First Posted: 2016-03-31
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-21
• Last Update Posted: 2016-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPARC1316 Dose 5	SPARC1316 Dose 5	Subjects will be administered with SPARC1316 dose 5
SPARC1316 Dose 1	SPARC1316 Dose 1	Subjects will be administered with SPARC1316 dose 1
Placebo	Placebo	The subjects will receive placebo.
SPARC1316 Dose 2	SPARC1316 Dose 2	Subjects will be administered with SPARC1316 dose 2
SPARC1316 Dose 3	SPARC1316 Dose 3	Subjects will be administered with SPARC1316 dose 3
SPARC1316 Dose 4	SPARC1316 Dose 4	Subjects will be administered with SPARC1316 dose 4

Primary Outcome Measures

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

Trial Locations

Locations (1)

SPARC study site; 🇬🇧 London, United Kingdom