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NCT03315507 · ClinicalTrials.gov registry record · Phase 1
A Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046 in Subjects With PAH
A Phase 1 study, sponsored by PhaseBio Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 3
- Enrollment target
NCT03315507: Completed Phase 1 study, sponsored by PhaseBio Pharmaceuticals.
NCT03315507 is a Phase 1 study that has completed, run by PhaseBio Pharmaceuticals. The registered enrollment target is 3 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03315507, a Phase 1 study, has completed, sponsored by PhaseBio Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 3 participants
- Enrollment target
Study Summary
PB1046-PT-CL-0005 is an open-label, dose-titration study to assess the safety, tolerability, and hemodynamic effects of individually dose-titrated PB1046 administered by weekly subcutaneous injection for 8 weeks in adult subjects with PAH who have a permanently implanted hemodynamic monitor in the distal pulmonary artery. The primary objectives of the study are to assess the overall safety, tolerability, and hemodynamic profile of a PB1046 across an individually titrated dose range.
Primary Outcome
Incidence and severity of AEs (described descriptively) and their relationship to study drug
Interventions
- DRUG PB1046 Subcutaneous Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2017-10-20 |
| Est. Completion | 2019-08-08 |
| Phase | Phase 1 |
What the finished NCT03315507 record still lists
NCT03315507 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 1 intervention - of which PB1046 Subcutaneous Injection is the first listed.
NCT03315507 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03315507 about?
NCT03315507 is a clinical study titled "A Study to Assess the Safety, Tolerability, and Hemodynamic Response of PB1046 in Subjects With PAH". PB1046-PT-CL-0005 is an open-label, dose-titration study to assess the safety, tolerability, and hemodynamic effects of individually dose-titrated PB1046 administered by weekly subcutaneous injection for 8 weeks in adult subjects with PAH who have a permanently implanted hemodynamic monitor in the d...
What is the current status of trial NCT03315507?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 3 participants. The study started on 2017-10-20. Estimated completion is 2019-08-08.
What interventions are being tested in trial NCT03315507?
The interventions under investigation include: PB1046 Subcutaneous Injection (DRUG).
Who is sponsoring clinical trial NCT03315507?
This trial is sponsored by PhaseBio Pharmaceuticals, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03315507's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 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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