drugset / Trial / NCT05790382
Single and Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of NM-101
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |