An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis

Phase 2CompletedNCT03229252

Spyryx Biosciences, Inc.91 enrolled

Overview

28-Day double-blinded efficacy and safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Cystic Fibrosis

Interventions

Placebo Inhalation SolutionDRUG

Normal Saline Inhalation Solution

SPX-101DRUG

SPX-101 Inhalation Solution

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Confirmed diagnosis of cystic fibrosis * ppFEV1 (percent predicted FEV1) between 50.0% and 80.0% * Stable CF Lung Disease * Males and non-pregnant, non-lactating females Exclusion Criteria: * Significant unstable co-morbidities within 28 days of screening * Has received an investigational drug within 28 days of screening

Locations (25)

University of Calgary Heritage Medical Research Center

Outcomes

Primary Outcomes

Change in Percent Predicted FEV1

Time frame: Baseline and Day 28

Secondary Outcomes

Number of Participants With Adverse Events

Time frame: Day 1 through Day 28

Change From Baseline Through Day 28 in Clinical Laboratory Tests

Chemistry, Hematology, Urinalysis

Time frame: Day 1 through Day 28

Data from ClinicalTrials.gov

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