A research study to find out if SPX-101 helps people with Cystic Fibrosis and to find out if it is safe.

Phase 1

• Conditions: Cystic Fibrosis; MedDRA version: 20.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-005230-30-PT
• Lead Sponsor: Spyryx Biosciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-31
• Study Completion: 2019-06-24
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

- Ability to provide written, personally signed, and dated informed consent
- Ability to self-administer the investigational product
- Diagnosis of cystic fibrosis as determined by the 2008 Cystic Fibrosis Foundation Consensus Guidelines
- Percent predicted forced expiratory volume in 1 second (ppFEV1) between 40.0% and 80.0% for cohort 1 and between 50.0% and 80% for cohort 2
- Stable CF lung disease
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- BMI < 18 kg/m2
- Use of a Cystic fibrosis transmembrane conductance regulator (CFTR) corrector or potentiator during the study or within 60 days before screening
- The presence of significant and unstable comorbidities within 28 days before screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified