Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Auto-injector with exenatide · 1 trial · 1 indication
The primary outcome measure is the number of device-related injection failures of the single-use, pre-filled auto-injector.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | exenatide suspension - 9 mg / 0.85 mL |
| Arm 2 | EXPERIMENTAL | exenatide suspension - 9 mg / 0.85 mL |
| Arm 3 | EXPERIMENTAL | exenatide suspension - 4.5 mg /1.1 mL |
| Arm 4 | EXPERIMENTAL | exenatide suspension - 9 mg / 1.1 mL |
| Arm 5 | EXPERIMENTAL | exenatide suspension - 9 mg / 1.5 mL |
| Name | Type | Description |
|---|---|---|
| Auto-injector with exenatide suspension | DRUG | A flexible study design to accommodate multiple cohorts. |
| Syringe with exenatide suspension | DRUG | A flexible study design to accommodate multiple cohorts. |
Inclusion Criteria: * Is at least 18 years old at Visit 1 (Screening). Subjects must be of legal age of consent. * Has no significant health issues that would preclude study participation, as determined by medical history and physical examination * Has body mass index of 22 kg/m2 to 45 kg/m2, inclu...
The Auto-injector with exenatide is an investigational small molecule being studied in healthy subjects. It is delivered via an auto-injector device and is currently in Phase 1 clinical development. The drug is being evaluated for use in healthy volunteers as part of a device assessment study.
The Auto-injector with exenatide is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate this drug in healthy subjects.
The Auto-injector with exenatide is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials to assess its safety and efficacy in healthy subjects.
The Auto-injector with exenatide is being studied in a completed Phase 1 clinical trial with the identifier NCT02349802. This trial, titled 'Autoinjector Device Assessment Study,' enrolled 3,052 healthy subjects in the United States and was a randomized, controlled study.
The Auto-injector with exenatide is a formulation of exenatide delivered via an auto-injector device. It is being studied for use in healthy subjects as part of a device assessment study. The drug is currently in Phase 1 clinical development by AstraZeneca.