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Completed

NCT Number: NCT02041221

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SPARC1316

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

SPARC study site

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPARC1316 Dose 1

Drug

The subjects will receive SPARC1316.

Placebo

Drug

Other names: The subjects will receive a matching placebo by oral inhalation.

SPARC1316 Dose 2

Drug

SPARC1316 Dose 3

Drug

SPARC1316 Dose 4

Drug

SPARC1316 Dose 5

Drug

Primary outcomes

  1. Number of Subjects With Adverse Events

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Sun Pharma Advanced Research Company Limited

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Jan 20, 2014
Registry last updated
May 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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