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

Phase 1CompletedNCT03056989

Spyryx Biosciences, Inc.5 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

SPX-101DRUG

Inhalation solution twice daily for 7 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

Saint Michael's Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Number of participants with adverse events

Time frame: Day 1 through Day 15

Secondary Outcomes

Relative change from baseline through Day 8 in percent predicted FEV1

Time frame: Screening and Day 1 through Day 8

Change from baseline through Day 8 in clinical laboratory tests

Chemistry, Hematology, Urinalysis

Time frame: Screening and Day 1 through Day 8

Data from ClinicalTrials.gov

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