drugset / Trial / NCT05790382

Single and Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of NM-101

NCT05790382 ↗

Phase 1 Unknown 56 enrolled Neuramedy Co. Ltd. Quotient Sciences · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

This is a Phase I, double-blind, randomised, two-part, single-ascending dose (Part 1) and multiple-ascending dose (Part 2) study of NM-101 in healthy males and healthy females of non-childbearing potential

Timeline

Start
2023-05-10
Primary completion
2024-05-30
Completion
2024-06-14

Drugs

EvaluationDrugModalityDoseRoute
Subject NM-101 Protein / enzyme biologic 10 mg/kg Intravenous
Subject NM-101 Protein / enzyme biologic 20 mg/kg Intravenous
Subject NM-101 Protein / enzyme biologic 40 mg/kg Intravenous
Subject NM-101 Protein / enzyme biologic 60 mg/kg Intravenous

Indications