Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
amilo-5MER · 1 trial · 1 indication
Assess and characterize the number of participants with clinically significant changes in safety assessments, including adverse events, physical examination findings, vital signs, clinical laboratory assessments, and urinalysis.
| Arm | Type | Description |
|---|---|---|
| A- amilo-5MER solution for subcutaneous administration or matching placebo- 10 mg | EXPERIMENTAL | Amilo-5MER solution for subcutaneous administration or matching placebo at a dose of 10 mg |
| B- amilo-5MER solution for subcutaneous administration or matching placebo- 30 mg | EXPERIMENTAL | Amilo-5MER solution for subcutaneous administration or matching placebo at a dose of 30 mg |
| C- amilo-5MER solution for subcutaneous administration or matching placebo- 90 mg | EXPERIMENTAL | Amilo-5MER solution for subcutaneous administration or matching placebo at a dose of 90 mg |
| D- amilo-5MER solution for subcutaneous administration or matching placebo- 180 mg | EXPERIMENTAL | Amilo-5MER solution for subcutaneous administration or matching placebo at a dose of 180 mg |
| E- amilo-5MER solution for subcutaneous administration or matching placebo- 360mg | EXPERIMENTAL | Amilo-5MER solution for subcutaneous administration or matching placebo at a dose of 360 mg |
| Name | Type | Description |
|---|---|---|
| amilo-5MER | DRUG | amilo-5MER is a 5 amino acid synthetic peptide MTADV (Methionine, Threonine, Alanine, Aspartic acid, Valine). |
Inclusion Criteria: 1. Healthy males (all parts) or healthy females (Part 3 only). 2. Aged 18 to 45 years (Parts 1 and 2) or aged 65 to 80 years (Part 3) inclusive at the time of signing informed consent. 3. Body mass index (BMI) of 19.0 to 31.0 kg/m2, with a body weight \<95 kg, as measured at scr...