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NCT02718495 · ClinicalTrials.gov registry record · Phase 1
Study Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic Fibrosis
A Phase 1 study, sponsored by Proteostasis Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT02718495: Completed Phase 1 study, sponsored by Proteostasis Therapeutics.
NCT02718495 is a Phase 1 study that has completed, run by Proteostasis Therapeutics. The registered enrollment target is 56 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02718495, a Phase 1 study, has completed, sponsored by Proteostasis Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
This trial will consist of three arms: Part A, Part B, and Part C. Part A has two groups. The first group will enroll adult subjects with cystic fibrosis (CF) into a single ascending dose (SAD) treatment group. The second group will enroll adult subjects with CF, including those on background treatment with ORKAMBI® and those not on a cystic fibrosis transmembrane conductance regulator (CFTR) modulator, into a multiple ascending dose (MAD) treatment group. Part B will enroll adult subjects with CF currently on stable ORKAMBI® background therapy for a minimum of 3 months into a Phase II treatment group consisting of two cohorts. Part C will enroll adult subjects with CF, including those on background treatment with KALYDECO® and those not on a CFTR modulator, into a Phase II treatment group consisting of three cohorts. Approximately 136 subjects will be enrolled.
Interventions
- DRUG Placebo
- DRUG PTI-428
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2016-07-19 |
| Est. Completion | 2017-11-28 |
| Phase | Phase 1 |
What the finished NCT02718495 record still lists
NCT02718495 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02718495 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02718495 about?
NCT02718495 is a clinical study titled "Study Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic Fibrosis". This trial will consist of three arms: Part A, Part B, and Part C. Part A has two groups. The first group will enroll adult subjects with cystic fibrosis (CF) into a single ascending dose (SAD) treatment group. The second group will enroll adult subjects with CF, including those on background treatm...
What is the current status of trial NCT02718495?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2016-07-19. Estimated completion is 2017-11-28.
What interventions are being tested in trial NCT02718495?
The interventions under investigation include: Placebo (DRUG), PTI-428 (DRUG).
Who is sponsoring clinical trial NCT02718495?
This trial is sponsored by Proteostasis Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02718495's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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