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

Spyryx Biosciences

Status and phase: Completed; Phase 1

Conditions: Cystic Fibrosis

Treatments: Drug: SPX-101

Study type: Interventional

Funder types: Industry

Identifiers

NCT03056989

SPX-101-CF-102

Details and patient eligibility

About

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

Enrollment: 5 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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5 participants in 3 patient groups

SPX-101 Low Dose

Experimental group

Description:

Inhalation Solution twice daily for 7 days.

Treatment:

Drug: SPX-101

SPX-101 Mid Dose

Experimental group

Description:

Inhalation Solution twice daily for 7 days.

Treatment:

Drug: SPX-101

SPX-101 High Dose

Experimental group

Description:

Inhalation Solution twice daily for 7 days.

Treatment:

Drug: SPX-101