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Completed

NCT Number: NCT03056989

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

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

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Saint Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPX-101

Drug

Inhalation solution twice daily for 7 days.

Primary outcomes

  1. Number of participants with adverse events

    Time frame: Day 1 through Day 15

Secondary outcomes

  1. Relative change from baseline through Day 8 in percent predicted FEV1

    Time frame: Screening and Day 1 through Day 8

  2. Change from baseline through Day 8 in clinical laboratory tests

    Time frame: Screening and Day 1 through Day 8

    Chemistry, Hematology, Urinalysis

Sponsors and collaborators

Lead sponsor

Spyryx Biosciences, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Feb 17, 2017
Registry last updated
Sep 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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