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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02692781 | A Single-dose, Dose-escalation Study of a Long-acting MOD-6031 in Healthy Overweight or Obese Subjects | PHASE1 | COMPLETED | 32 | — | — | Feb 1, 2016 | Dec 15, 2016 | Sep 30, 2019 | 1 | Israel |
| Arm | Type | Description |
|---|---|---|
| Dose Cohort 1 | EXPERIMENTAL | 20mg MOD-6031 / Placebo |
| Dose Cohort 2 | EXPERIMENTAL | 50mg MOD-6031 / Placebo |
| Dose Cohort 3 | EXPERIMENTAL | 100mg MOD-6031 / Placebo |
| Dose Cohort 4 | EXPERIMENTAL | 150mg MOD-6031 / Placebo |
| Dose Cohort 5 | EXPERIMENTAL | 200mg MOD-6031 / Placebo |
| Name | Type | Description |
|---|---|---|
| MOD-6031 | DRUG | - |
| Placebo control | OTHER | - |
Inclusion Criteria: * Healthy male, between 18 to 55 years of age. * BMI 27-35 Kg/m2 (inclusive). * Generally good health. * Triglyceride ≤ 400mg/ml * ECG with no clinically significant abnormalities. * Negative HIV, hepatitis B or hepatitis C serology tests at screening * No significant abnormalit...