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NCT03844191 · ClinicalTrials.gov registry record · Phase 1
A Randomized Phase 1 Dose-Escalation Study of Subcutaneously(SC) Administered RUC-4
A Phase 1 study, sponsored by CeleCor Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 44
- Enrollment target
NCT03844191 is a Phase 1 study that has completed, run by CeleCor Therapeutics. The registered enrollment target is 44 participants.
The verdict
NCT03844191, a Phase 1 study, has completed, sponsored by CeleCor Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 44 participants
- Enrollment target
Study Summary
This study is designed to assess tolerability of the weight-adjusted dose of RUC-4 (mg/kg) required to achieve 80% or more inhibition of the initial slope of platelet aggregation to 20 µM ADP by Light Transmission Aggregometry (LTA) within 15 minutes of SC administration of RUC-4 with return toward baseline values within 4 hours in healthy volunteers and subjects on aspirin with stable coronary artery disease (CAD). In the Dose Expansion Part, VerifyNow PRUTest will be used to measure platelet aggregation in addition to LTA. Since the goal of RUC-4 therapy is to achieve maximal antiplatelet therapy as rapidly as possible, first the tolerability of the weight-adjusted dose (mg/kg) that inhibits ADP-induced platelet aggregation by 80% or more in 5 of 6 healthy volunteers will be identified. A similar dose escalation will be subsequently performed in subjects with CAD who are taking aspirin. To facilitate administration using a single weight-adjusted (mg/kg) dose for a defined group of subjects weighing between 55 and 120 kg, the study will also evaluate the safety and biologic effect on platelet aggregation of the weight adjusted (mg/kg) dose when administered to subjects with weights at either end of this range.
Interventions
- DRUG RUC-4 Compound
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2019-02-18 |
| Est. Completion | 2019-12-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03844191
The ClinicalTrials.gov registry entry for NCT03844191 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CeleCor Therapeutics, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which RUC-4 Compound is the first listed.
NCT03844191 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03844191 about?
NCT03844191 is a clinical study titled "A Randomized Phase 1 Dose-Escalation Study of Subcutaneously(SC) Administered RUC-4". This study is designed to assess tolerability of the weight-adjusted dose of RUC-4 (mg/kg) required to achieve 80% or more inhibition of the initial slope of platelet aggregation to 20 µM ADP by Light Transmission Aggregometry (LTA) within 15 minutes of SC administration of RUC-4 with return toward ...
What is the current status of trial NCT03844191?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 44 participants. The study started on 2019-02-18. Estimated completion is 2019-12-01.
What interventions are being tested in trial NCT03844191?
The interventions under investigation include: RUC-4 Compound (DRUG).
Who is sponsoring clinical trial NCT03844191?
This trial is sponsored by CeleCor Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov.
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