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...
Amilo-5MER is an investigational small molecule being developed for the treatment of inflammatory disease. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and is still being studied for safety and tolerability in humans.
Amilo-5MER is a small molecule designed to modulate inflammatory pathways. Its specific molecular target has not been disclosed, but it is being investigated for its potential to treat inflammatory conditions by interfering with the underlying inflammatory processes.
Amilo-5MER is being developed by Galmed Pharmaceuticals Ltd., a biopharmaceutical company listed on the NASDAQ under the ticker symbol GLMD. The company is conducting clinical trials to evaluate the drug's safety and tolerability in healthy volunteers.
Amilo-5MER is in Phase 1 clinical development. A first-in-human study has been completed, which evaluated single and multiple doses of the drug in healthy subjects. The drug is investigational and has not been approved by the FDA or any other regulatory agency.
Amilo-5MER has one completed clinical trial registered under NCT05857215, titled "A First-in-Human Study of Single and Multiple Doses of Amilo-5MER in Healthy Subjects." This Phase 1 study enrolled 55 participants in the United Kingdom and was a randomized, double-blind, controlled trial.
No alternative names for Amilo-5MER have been disclosed. It is a unique investigational compound developed by Galmed Pharmaceuticals and is not known to be identical to any other marketed or investigational drug.