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 for use in knee replacement surgery, specifically for patients undergoing arthroplasty of the knee. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
EP-7041 is being developed by Cadrenal Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CVKD. The company is conducting clinical trials to evaluate the safety and pharmacokinetics of this investigational drug.
EP-7041 is in Phase 1 clinical development. A Phase 1 study has been completed, which evaluated the safety, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of the drug in healthy subjects.
EP-7041 has one completed Phase 1 clinical trial, identified as NCT02914353. This study evaluated the safety, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of EP-7041 in 80 healthy subjects in Australia.
EP-7041 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development, meaning it has not yet been evaluated in later-stage trials or submitted for regulatory approval.