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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02919800 | A Single-dose, Dose-escalation Study of a Long-acting MOD-5014 in Healthy Adult Male | PHASE1 | COMPLETED | 32 | — | — | Jan 22, 2017 | Feb 21, 2018 | Sep 30, 2019 | 1 | Israel |
| Arm | Type | Description |
|---|---|---|
| MOD-5014 | EXPERIMENTAL | MOD-5014 longevity is the result of fusion of three consecutive C-terminal peptide (CTP) domains to the C-terminus of FVII. CTP technology is based on a natural peptide, the C-terminal peptide of the beta chain of human chorionic gonadotropin (hCG), which provides hCG with the required longevity to maintain pregnancy (initial half-life \[t1/2\] \~10 h, terminal t1/2 \~37 h). The beta chain of luteinizing hormone (LH), a gonadotropin that triggers ovulation, is almost identical to hCG but does not include the CTP. As a result, LH has a significantly shorter half-life in blood (initial t1/2 \~1 h, terminal t1/2 \~10 h) (Fares et al., 1992). |
| MOD-5014 Placebo | PLACEBO_COMPARATOR | Placebo solution for SC injection containing the same inactive ingredients used in the active drug product at matching volumes |
| Name | Type | Description |
|---|---|---|
| MOD-5014 | BIOLOGICAL | MOD-5014, a long-acting modified recombinant Factor VIIa |
| MOD-5014 Placebo | OTHER | Placebo solution for SC injection containing the same inactive ingredients used in the active drug product at matching volumes |
Inclusion Criteria: 1. Men, 18-50 years of age, inclusive, at the screening visit. 2. Subjects must provide written informed consent prior to participating in the study. 3. Considered healthy based on medical history, physical examination and clinical laboratory results. 4. Body Mass Index (BMI) 19...