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NCT03522935 · ClinicalTrials.gov registry record · Phase 1
Subcutaneous Elafin in Healthy Subjects
A Phase 1 study of Pulmonary Arterial Hypertension, sponsored by Roham T. Zamanian.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT03522935: Completed Phase 1 study of Pulmonary Arterial Hypertension, sponsored by Roham T. Zamanian.
NCT03522935 is a Phase 1 study of Pulmonary Arterial Hypertension that has completed, run by Roham T. Zamanian. The registered enrollment target is 30 participants, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03522935, a Phase 1 study of Pulmonary Arterial Hypertension, has completed, sponsored by Roham T. Zamanian.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
A multiple-ascending-dose (MAD), randomized, placebo-controlled, blinded trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Elafin in healthy adult subjects. The purpose of this study is to assess Elafin that is being developed for treatment of PAH. Elafin inhibits elastase, an enzyme that is increased in pulmonary hypertension and is a major factor in the development of PAH. Elafin will be administered subcutaneously daily for 7 days in normal healthy subjects followed over a 28 day time period.
Primary Outcome
Safety and tolerability will be determined on the basis of adverse events reported and the severity of adverse events.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Elafin
Study Locations (1)
North Carolina
- Duke Early Phase Research Unit (DEPRU) - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2019-03-18 |
| Est. Completion | 2020-11-18 |
| Phase | Phase 1 |
What the finished NCT03522935 record still lists
NCT03522935 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 462-participant average among 63 other Pulmonary Arterial Hypertension trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Pulmonary Arterial Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03522935 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT03522935 about?
NCT03522935 is a clinical study titled "Subcutaneous Elafin in Healthy Subjects". A multiple-ascending-dose (MAD), randomized, placebo-controlled, blinded trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of Elafin in healthy adult subjects. The purpose of this study is to assess Elafin that is being developed for treatment of PAH. Elafin inhibits...
What is the current status of trial NCT03522935?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2019-03-18. Estimated completion is 2020-11-18.
What conditions does trial NCT03522935 study?
This clinical trial studies the following conditions: Pulmonary Arterial Hypertension.
What interventions are being tested in trial NCT03522935?
The interventions under investigation include: Placebo (DRUG), Elafin (DRUG).
Who is sponsoring clinical trial NCT03522935?
This trial is sponsored by Roham T. Zamanian, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03522935 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03522935's enrollment target sits among peer trials
30 41st of 63 higher than 20 of 63 other Pulmonary Arterial Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Arterial Hypertension 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.
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