drugset / Trial / NCT03866577
Safety and Tolerability of M254 in Healthy Volunteers and Immune Thrombocytopenic Purpura (ITP) Patients
RandomizedSequentialOpen-labelTreatment
Summary
The purpose of this study is to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of M254 after administration of a single ascending dose and repeat doses in healthy volunteers and immune thrombocytopenic purpura (ITP) patients. The pharmacodynamics of the drug will be measured as platelet response in patients with ITP.
Timeline
- Start
- 2018-12-21
- Primary completion
- 2021-06-09
- Completion
- 2021-06-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Immune Globulin Intravenous (Human) | Protein / enzyme biologic | — | Intravenous |
| Subject | M254 | Unknown | — | Intravenous |