drugset
drugset / Trial / NCT05857215

A First-in-Human Study of Single and Multiple Doses of Amilo-5MER in Healthy Subjects

NCT05857215 ↗

Phase 1 Completed 55 enrolled Galmed Pharmaceuticals Ltd Quotient Sciences · collab
RandomizedSequentialQuadruple-blindTreatment

Summary

This is a three-part, single Centre, double-blind, randomized, placebo-controlled first-in-human study of single ascending doses (SADs, Part 1) and multiple doses (Part 2) of amilo-5MER in healthy young adult male subjects and a single dose cohort in healthy elderly male and female subjects (Part 3)

Timeline

Start
2021-03-05
Primary completion
2021-07-01
Completion
2021-07-01

Drugs

EvaluationDrugModalityDoseRoute
Subject amilo-5MER Peptide 10 mg Subcutaneous
Subject amilo-5MER Peptide 30 mg Subcutaneous
Subject amilo-5MER Peptide 90 mg Subcutaneous
Subject amilo-5MER Peptide 180 mg Subcutaneous
Subject amilo-5MER Peptide 360 mg Subcutaneous

Indications

inflammatory disease