Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
EP=7041 · 1 trial · 1 indication
Assessment of safety and tolerability to EP-7041, administered as a single IV bolus, will be based on adverse events. Each AE will be graded with respect to its relationship to treatment using five categories: not related, unlikely, possible, probable, and highly probable. Each AE will also be graded on a three-point severity scale: mild, moderate, and severe. Adverse events will be coded by body system and preferred term using the MedDRA (Medical Dictionary for Regulatory Activities) dictionary. Assessments as to the effect of EP-7041 on vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight will also be made. The number and percentage of subjects experiencing adverse events will be tabulated for each treatment group by body system and preferred term. The number and percentage of subjects experiencing AEs will also be tabulated by relationship to drug treatment and by severity. If an AE is
Assessment of safety and tolerability to EP-7041, administered as a continuous IV infusion over 5 days, will be based on adverse events. Each AE will be graded with respect to its relationship to treatment using five categories: not related, unlikely, possible, probable, and highly probable. Each AE will also be graded on a 3-point severity scale: mild, moderate, and severe. Adverse events will be coded by body system and preferred term using the Medical Dictionary for Regulatory Activities dictionary. Assessments as to the effect of EP-7041 on vital signs, 12-lead ECG, telemetry, clinical laboratory parameters, physical examination, and local response to each injection, and body weight will also be made. The number and percentage of subjects experiencing adverse events will be tabulated for each treatment group by body system and preferred term. The number and percentage of subjects experiencing AEs will also be tabulated by relationship to drug treatment and by severity.
| Arm | Type | Description |
|---|---|---|
| Experimental - EP-7041 | EXPERIMENTAL | Single Ascending Dose: Single IV dose for each cohort; dose range 0.01 mg/kg to 1.0 mg/kg Multiple Ascending Dose: 0.01 mg/kg/h - 5 x 24 h continuous infusion up to 0.6 mg/kg/h - 5 x 24 h continuous infusion |
| Placebo - Sterile Saline | PLACEBO_COMPARATOR | Single Ascending Dose: Single IV dose for each cohort; Multiple Ascending Dose: 5 x 24 h continuous infusion for each cohort |
| Name | Type | Description |
|---|---|---|
| EP=7041 | DRUG | Factor X!a Inhibitor |
| Placebo | DRUG | Normal Saline |
Inclusion Criteria: * Male or female, non-smoker (no use of tobacco products within 3 months prior to screening), ≥18 and ≤60 years of age, with Body Mass Index (BMI) \> 18.5 and \< 32.0 kg/m2 and a weight of at least 60 kg but not greater than 100 kg. * Healthy as defined by: 1. No history of a...
EP=7041 is an investigational small molecule being developed by Cadrenal Therapeutics, Inc. (ticker CVKD). It has been studied in a Phase 1 clinical trial involving healthy adult volunteers in Australia. The program is focused on the setting of knee arthroplasty, also known as knee replacement surgery.
EP=7041 is being developed for use in patients undergoing knee arthroplasty, or knee replacement surgery. The completed Phase 1 study enrolled healthy subjects rather than patients, so the compound has been evaluated in a healthy volunteer setting to date. It is investigational and has not been approved for any use.
EP=7041 is being developed by Cadrenal Therapeutics, Inc., which trades under the ticker symbol CVKD. The company is the sponsor of the clinical program for this small molecule asset.
EP=7041 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound is investigational and has not been approved by the FDA or any other regulatory agency for commercial use.
EP=7041 has been evaluated in one completed Phase 1 trial, NCT02914353, titled a study to evaluate safety, PK and PD of single and multiple ascending doses of EP-7041 in healthy subjects. The trial was randomized, double-blind, placebo-controlled, enrolled 80 participants, and was conducted in Australia.