Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Asthma

Treatments: Drug: SPARC1316 Dose 3; Drug: SPARC1316 Dose 4; Drug: SPARC1316 Dose 1; Drug: Placebo; Drug: SPARC1316 Dose 2; Drug: SPARC1316 Dose 5

Study type: Interventional

Funder types: Industry

Identifiers

NCT02041221

SPARC_Ltd_ CLR_13_16

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 6 patient groups, including a placebo group

SPARC1316 Dose 1

Experimental group

Description:

Subjects will be administered with SPARC1316 dose 1

Treatment:

Drug: SPARC1316 Dose 1

Placebo

Placebo Comparator group

Description:

The subjects will receive placebo.

Treatment:

Drug: Placebo

SPARC1316 Dose 2

Experimental group

Description:

Subjects will be administered with SPARC1316 dose 2

Treatment:

Drug: SPARC1316 Dose 2

SPARC1316 Dose 3

Experimental group

Description:

Subjects will be administered with SPARC1316 dose 3

Treatment:

Drug: SPARC1316 Dose 3

SPARC1316 Dose 4

Experimental group

Description:

Subjects will be administered with SPARC1316 dose 4

Treatment:

Drug: SPARC1316 Dose 4

SPARC1316 Dose 5

Experimental group

Description:

Subjects will be administered with SPARC1316 dose 5

Treatment:

Drug: SPARC1316 Dose 5