A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis

Phase 1

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: SPX-101

• Registration Number: NCT03056989
• Lead Sponsor: Spyryx Biosciences, Inc.

Brief Summary

Ascending dose, 7-day, open label safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-15
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-17
• Study Start: 2017-05-31
• Primary Completion: 2017-08-02
• Study Completion: 2017-08-02
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-01
• Last Update Posted: 2017-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

• Confirmed diagnosis of CF
• FEV1 ≥ 40% predicted normal
• Stable CF lung disease
• Non-pregnant, non-lactating females

Exclusion Criteria

• Significant unstable co-morbidities within 28 days of screening as judged by the Investigator.
• Has received an investigational drug within the past 30 days

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SPX-101 Low Dose	SPX-101	Inhalation Solution twice daily for 7 days.
SPX-101 High Dose	SPX-101	Inhalation Solution twice daily for 7 days.
SPX-101 Mid Dose	SPX-101	Inhalation Solution twice daily for 7 days.

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse events	Day 1 through Day 15

Secondary Outcome Measures

Name	Time	Method
Change from baseline through Day 8 in clinical laboratory tests	Screening and Day 1 through Day 8	Chemistry, Hematology, Urinalysis
Relative change from baseline through Day 8 in percent predicted FEV1	Screening and Day 1 through Day 8

Trial Locations

Locations (1)

Saint Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada