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NCT03453060 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability Study of E-WE Thrombin in Healthy Adult Subjects
A Phase 1 study of Thrombosis, sponsored by Aronora.
- Completed
- Registry status
- Phase 1
- Development phase
- 21
- Enrollment target
- 1
- Study location
NCT03453060: Completed Phase 1 study of Thrombosis, sponsored by Aronora.
NCT03453060 is a Phase 1 study of Thrombosis that has completed, run by Aronora. The registered enrollment target is 21 participants, below the 470-participant average among 28 other Thrombosis trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03453060, a Phase 1 study of Thrombosis, has completed, sponsored by Aronora.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 21 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the safety, tolerability and pharmacodynamics of a single iv dose of E-WE Thrombin in healthy adult subjects.
Primary Outcome
TEAEs will be determined by symptom driven physical examinations that can include assessment of the skin, head, ears, eyes, nose, throat, respiratory system, cardiovascular system, gastrointestinal system, neurological condition, blood and lymphatic systems, and the musculoskeletal system.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG E-WE Thrombin- Dose 1
- DRUG E-WE Thrombin- Dose 2
- DRUG E-WE Thrombin- Dose 3
- DRUG E-WE Thrombin- Dose 4
Study Locations (1)
Arizona
- Celerion - Tempe
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-05-30 |
| Est. Completion | 2018-11-25 |
| Phase | Phase 1 |
What the finished NCT03453060 record still lists
NCT03453060 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 470-participant average among 28 other Thrombosis trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Thrombosis appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT03453060 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT03453060 about?
NCT03453060 is a clinical study titled "Safety and Tolerability Study of E-WE Thrombin in Healthy Adult Subjects". The purpose of this study is to assess the safety, tolerability and pharmacodynamics of a single iv dose of E-WE Thrombin in healthy adult subjects.
What is the current status of trial NCT03453060?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 21 participants. The study started on 2018-05-30. Estimated completion is 2018-11-25.
What conditions does trial NCT03453060 study?
This clinical trial studies the following conditions: Thrombosis.
What interventions are being tested in trial NCT03453060?
The interventions under investigation include: Placebo (OTHER), E-WE Thrombin- Dose 1 (DRUG), E-WE Thrombin- Dose 2 (DRUG), E-WE Thrombin- Dose 3 (DRUG), E-WE Thrombin- Dose 4 (DRUG).
Who is sponsoring clinical trial NCT03453060?
This trial is sponsored by Aronora, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03453060 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Thrombosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03453060's enrollment target sits among peer trials
21 20th of 28 higher than 9 of 28 other Thrombosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Thrombosis 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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