Safety, Tolerability, and Pharmacokinetics of PTI-808, PTI-801, and PTI-428 Combination Therapy in Subjects With Cystic Fibrosis
- Therapeutic category
- Restore CFTR Function
- Trial status
- Completed Participating Centres
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 FibrosisThe 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.
- Trial Reference Number
- Trial type
- CFTR Modulators
- Last edited date
- CF sponsor
- Proteostasis Therapeutics, Inc.
- CF sponsor type
Who can take part?
- Top inclusion criteria
- 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
- Top exclusion criteria
- 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.