Title

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
  • Phase

    Phase 1
  • Study Type

    Interventional
  • Status

    Completed No Results Posted
  • Intervention/Treatment

    spx-101 ...
  • Study Participants

    5
Ascending dose, 7-day, open label safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.
Study Started
May 31
2017
Primary Completion
Aug 02
2017
Study Completion
Aug 02
2017
Last Update
Sep 05
2017

Drug SPX-101

Inhalation solution twice daily for 7 days.

SPX-101 Low Dose Experimental

Inhalation Solution twice daily for 7 days.

SPX-101 Mid Dose Experimental

Inhalation Solution twice daily for 7 days.

SPX-101 High Dose Experimental

Inhalation Solution twice daily for 7 days.

Criteria

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
No Results Posted