Ignite Creation Date:
2024-05-06 @ 12:45 PM
Last Modification Date:
2024-10-26 @ 1:04 PM
Study NCT ID:
NCT03844191
Status:
COMPLETED
Last Update Posted:
2020-02-19
First Post:
2019-02-13
Brief Title:
A Randomized Phase 1 Dose-Escalation Study of SubcutaneouslySC Administered RUC-4
Sponsor:
CeleCor Therapeutics
Organization:
CeleCor Therapeutics
Study Overview
Official Title:
A Randomized Phase 1 Dose-Escalation Study in Healthy Volunteers and Subjects on Aspirin With Stable Coronary Artery Disease to Assess the Safety Tolerability Pharmacokinetics and Pharmacodynamics of Subcutaneous RUC-4
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to assess tolerability of the weight-adjusted dose of RUC-4 mgkg 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 mgkg 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 mgkg 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 mgkg dose when administered to subjects with weights at either end of this range
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 mgkg 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 mgkg 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 mgkg dose when administered to subjects with weights at either end of this range
Detailed Description:
Part 1 Dose Escalation
Drug RUC-4 005 mgkg Cohort 1 Drug RUC-4 0075 mgkg Cohort 2 Drug Placebo Cohorts 1-2
Part 2 Dose Escalation Drug RUC-4 Cohort 1-3 doses to be defined Placebo Cohorts 1-3
Part 2 Dose Expansion Drug RUC-4 dose to be defined 1 Cohort Drug Placebo 1Cohort
Drug RUC-4 005 mgkg Cohort 1 Drug RUC-4 0075 mgkg Cohort 2 Drug Placebo Cohorts 1-2
Part 2 Dose Escalation Drug RUC-4 Cohort 1-3 doses to be defined Placebo Cohorts 1-3
Part 2 Dose Expansion Drug RUC-4 dose to be defined 1 Cohort Drug Placebo 1Cohort
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None