A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis

S

Synspira

Status and phase

Terminated
Phase 1

Conditions

Lung Inflammation
Burkholderia Cepacia Infection
Lung Infection Pseudomonal
Multi-antibiotic Resistance
Lung; Infection, Atypical Mycobacterium
Cystic Fibrosis Pulmonary Exacerbation
Pulmonary Inflammation
Burkholderia Infections
Lung Infection
Lung Diseases
Cystic Fibrosis Lung
Antibiotic Resistant Infection
Pulmonary Disease
Cystic Fibrosis
Respiratory Tract Disease
Cystic Fibrosis With Exacerbation

Treatments

Drug: Inhaled Placebo
Drug: Inhaled SNSP113

Study type

Interventional

Funder types

Industry

Identifiers

NCT03309358
SNSP113-17-101

Details and patient eligibility

About

Although Cystic Fibrosis is a complex genetic disease affecting many organs, lung disease is the primary cause of mortality. The objective of this study is to determine the safety and tolerability of SNSP113 in healthy subjects and subjects with stable cystic fibrosis.

Enrollment

32 patients

Sex

All

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Part A

  • Healthy male adults ≥18 and ≤50 years of age at screening.
  • Baseline FEV1 80-120% of predicted at Screening.
  • Oxygen saturation of ≥ 96% on room air as determined by pulse oximetry at Screening.
  • Screening laboratory tests within normal limits.

Part B

  • Female and Male subjects who are ≥18 years of age and a confirmed diagnosis of CF.
  • FEV1 >50% of predicted.
  • Oxygen saturation of ≥ 94% on room air as determined by pulse oximetry at Screening.
  • Stable CF pulmonary disease as judged by the Investigator.

Exclusion criteria

Part A

  • Any history of any form of lung disease or any systemic disease that may affect the lung or pulmonary function.
  • Former regular smoker or has smoked tobacco or cannabis products within the last 30 days.
  • Any history of any form of liver disease, renal disease, cardiac disease, hematologic disease, neurologic disease, atopy or any chronic condition.
  • Participation in one or more healthy subject studies within the prior 3 months.

Part B

  • Participation in a clinical trial involving receipt of an investigational product within the 30 days prior to screening.
  • Female subjects who are pregnant (a negative serum pregnancy test must be demonstrated at screening), have a positive pregnancy test, are lactating or who plan to become pregnant within 90 days after dosing.
  • Subjects requiring supplemental oxygen.
  • Hemoptysis of >5 mL within 12 weeks of screening.
  • Listed for organ transplantation.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Double Blind

32 participants in 2 patient groups, including a placebo group

Inhaled SNSP113
Experimental group
Treatment:
Drug: Inhaled SNSP113
Inhaled Placebo
Placebo Comparator group
Treatment:
Drug: Inhaled Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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