Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02914353 | Study to Evaluate Safety, PK and PD of Single and Multiple Ascending Doses of EP-7041 in Healthy Subjects | PHASE1 | COMPLETED | 80 | — | — | Jul 1, 2016 | May 1, 2017 | May 31, 2017 | 1 | Australia |
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...