Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316

NCT02041221 | Completed Phase 1 Results

• 1 other identifier: SPARC_Ltd_ CLR_13_16
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

pharmacokinetics, pharmacodynamics, asthma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (6)

SPARC1316 Dose 1

EXPERIMENTAL

Subjects will be administered with SPARC1316 dose 1

Drug: SPARC1316 Dose 1

Placebo

PLACEBO COMPARATOR

The subjects will receive placebo.

Drug: Placebo

SPARC1316 Dose 2

EXPERIMENTAL

Subjects will be administered with SPARC1316 dose 2

Drug: SPARC1316 Dose 2

SPARC1316 Dose 3

EXPERIMENTAL

Subjects will be administered with SPARC1316 dose 3

Drug: SPARC1316 Dose 3

SPARC1316 Dose 4

EXPERIMENTAL

Subjects will be administered with SPARC1316 dose 4

Drug: SPARC1316 Dose 4

SPARC1316 Dose 5

EXPERIMENTAL

Subjects will be administered with SPARC1316 dose 5

Drug: SPARC1316 Dose 5

Interventions

SPARC1316 Dose 1 DRUG

The subjects will receive SPARC1316.

SPARC1316 Dose 1

Placebo DRUG

Also known as: The subjects will receive a matching placebo by oral inhalation.

Placebo

SPARC1316 Dose 2 DRUG

SPARC1316 Dose 2

SPARC1316 Dose 3 DRUG

SPARC1316 Dose 3

SPARC1316 Dose 4 DRUG

SPARC1316 Dose 4

SPARC1316 Dose 5 DRUG

SPARC1316 Dose 5

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Pharma Advanced Research Company Limited: lead

Study Sites (1)

SPARC study site

London, London, United Kingdom

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Dr Shravanti Bhowmik
• Organization: SPARC

+91 22 66455645

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 20, 2014
• Study Start: January 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 23, 2016
• Results First Posted: March 31, 2016

Record last verified: 2016-04

Locations

GB (1)