Safety, Tolerability, and Pharmacokinetics of PTI-808, PTI-801, and PTI-428 Combination Therapy in Subjects With Cystic Fibrosis
Details
- Therapeutic approach
- Restore CFTR Function
- Trial status
- Closed with results Participating Centres
- Trials Tracker ID
- TT001936
- Last updated
- 28/01/2019
Full title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study Designed to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808-02, and PTI-428 Combination Therapy in Subjects With Cystic Fibrosis
Study detailsThe study is a randomized, double-blind, placebo-controlled, study that will be conducted at multiple centers in subjects with Cystic Fibrosis (CF) who are homozygous for the F508del mutation.
- Phase
- Phase 1
- CF sponsor
- Proteostasis Therapeutics, Inc.
- CF sponsor type
- Commercial
Who can take part?
- Age range
- 18 years and older
- Including people
Homozygous for F508del mutation
Forced expiratory volume in 1 second (FEV1) 40-90% predicted, inclusive.
Non-smoker and non-tobacco user for a minimum of 30 days prior to screening- Excluding people
Currently taking or has taken a CFTR modulator within 30 days prior to initial dose of study drugs
Participation in another clinical trial or treatment with an investigational agent within 28 days of Day 1
History of organ transplantation.