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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: Completed Phase 1 study, sponsored by CeleCor Therapeutics.
NCT03844191 is a Phase 1 study that has completed, run by CeleCor Therapeutics. The registered enrollment target is 44 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
inhibition of platelet aggregation
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 |
What the finished NCT03844191 record still lists
NCT03844191 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 1 intervention - of which RUC-4 Compound is the first listed.
NCT03844191 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03844191's enrollment target sits among peer trials
44 1086th of 2000 higher than 901 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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