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

A Phase 1, Single-Center, Open-Label Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03056989

Enrollment

Registered

2017-02-17

Start date

2017-05-31

Completion date

2017-08-02

Last updated

2017-09-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Brief summary

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

Interventions

DRUGSPX-101

Inhalation solution twice daily for 7 days.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame
Number of participants with adverse events	Day 1 through Day 15

Secondary

Measure	Time frame	Description
Relative change from baseline through Day 8 in percent predicted FEV1	Screening and Day 1 through Day 8	—
Change from baseline through Day 8 in clinical laboratory tests	Screening and Day 1 through Day 8	Chemistry, Hematology, Urinalysis

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026