drugset / Trial / NCT04369586
A Phase I Clinical Trial of Meplazumab in Healthy Volunteer
RandomizedParallel-groupTriple-blindOther
Summary
This is a single center, double-blinded, placebo-controlled phase I clinical trail in healthy volunteer of meplazumab for injection. The primary objective of this phase I trial is to evaluate the safety, tolerability, pharmacokinetic characteristics and occupancy characteristics of peripheral blood cell receptors of meplazumab in healthy volunteer, and provide a reference for the dosage of meplazumab in phase II clinical trial.
Timeline
- Start
- 2020-04-25
- Primary completion
- 2020-08-18
- Completion
- 2020-11-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Meplazumab | Monoclonal antibody | 0.06 mg/kg | — |
| Subject | Meplazumab | Monoclonal antibody | 0.12 mg/kg | — |
| Subject | Meplazumab | Monoclonal antibody | 0.2 mg/kg | — |
| Subject | Meplazumab | Monoclonal antibody | 0.3 mg/kg | — |
| Subject | Meplazumab | Monoclonal antibody | 0.42 mg/kg | — |
| Subject | Meplazumab | Monoclonal antibody | 0.56 mg/kg | — |
Indications
No indication recorded.