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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03309358
• Date of registration: 05/10/2017
• Prospective Registration: No
• Primary sponsor: Synspira, Inc.
• Public title: A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis
• Scientific title: A Multiple-Site, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study to Assess the Safety and Tolerability of Inhaled SNSP113 in Healthy Male Subjects (Part A) and Subjects With Stable Cystic Fibrosis (Part B)
• Date of first enrolment: September 28, 2017
• Target sample size: 32
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03309358
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

United Kingdom

Contacts

• Name: Maria Theresa Basco, MD, MPH
• Affiliation: Synspira, Inc.

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Antibiotic Resistant Infection

Pulmonary Disease

Cystic Fibrosis

Cystic Fibrosis With Exacerbation

Burkholderia Cepacia Infection

Respiratory Tract Disease

Lung Infection Pseudomonal

Lung; Infection, Atypical Mycobacterium

Lung Infection

Lung Inflammation

Pulmonary Inflammation

Burkholderia Infections

Cystic Fibrosis Lung

Multi-antibiotic Resistance

Cystic Fibrosis Pulmonary Exacerbation

Lung Diseases

Intervention(s)

Drug: Inhaled SNSP113

Drug: Inhaled Placebo

Primary Outcome(s)

Incidence of adverse events [Time Frame: 8 days]

Spirometry [Time Frame: 8 days]

Pulse Oximetry [Time Frame: 8 days]

Secondary Outcome(s)

Observed maximum plasma concentration, taken directly from the individual concentration-time curve (Cmax) [Time Frame: Days 1, 2 and 8]

Area under concentration-time curve from time zero extrapolated to infinity (AUC) [Time Frame: Days 1, 2 and 8]

Secondary ID(s)

SNSP113-17-101

Source(s) of Monetary Support

Please refer to primary and secondary sponsors