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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 is a Phase 1 study that has completed, run by Proteostasis Therapeutics. The registered enrollment target is 56 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02718495
The ClinicalTrials.gov registry entry for NCT02718495 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Proteostasis Therapeutics, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02718495 reports 0 study locations.
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.
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