An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis ((HOPE-1))

Spyryx Biosciences

Status and phase: Completed; Phase 2

Conditions: Cystic Fibrosis

Treatments: Drug: Placebo Inhalation Solution; Drug: SPX-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT03229252

SPX-101-CF-201

Details and patient eligibility

About

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

Enrollment: 91 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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91 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo Inhalation solution twice daily for 28 days.

Treatment:

Drug: Placebo Inhalation Solution

SPX-101 Low Dose

Experimental group

Description:

Inhalation solution twice daily for 28 days.

Treatment:

Drug: SPX-101

SPX-101 High Dose

Experimental group

Description:

Inhalation solution twice daily for 28 days.

Treatment:

Drug: SPX-101