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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02625636 | A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Doses of SAR438544 in Comparison to Placebo and Glucagon in Healthy Subjects and Type 1 Diabetes Mellitus Patients | PHASE1 | COMPLETED | 20 | — | — | Dec 1, 2015 | Feb 1, 2016 | Aug 23, 2016 | 1 | United States |
| Arm | Type | Description |
|---|---|---|
| SAR438544 dose 1 | EXPERIMENTAL | Single dose of SAR438544 given SC under fasting conditions |
| SAR438544 dose 2 | EXPERIMENTAL | Single dose of SAR438544 given SC under fasting conditions |
| SAR438544 dose 3 | EXPERIMENTAL | Single dose of SAR438544 given SC under fasting conditions |
| Placebo | PLACEBO_COMPARATOR | Single dose of placebo given SC under fasting conditions |
| Glucagon | ACTIVE_COMPARATOR | Single dose of glucagon given SC under fasting conditions |
| SAR438544 Optional Dose | EXPERIMENTAL | Optional lower, intermediate, or higher dose of SAR438544 given SC under fasting conditions |
| Name | Type | Description |
|---|---|---|
| SAR438544 | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| placebo | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
| r-glucagon | DRUG | Pharmaceutical form: solution Route of administration: subcutaneous |
Inclusion criteria : Healthy subjects: * Male or female subjects, between 18 and 45 years of age, inclusive. * Body weight between 50.0 and 100.0 kg, inclusive, if male, and between 40.0 and 90.0 kg, inclusive, if female, body mass index (BMI) between 18.0 and 30.0 kg/m\^2, inclusive. * Certified ...