Clinical Trials Directory

Trials / Completed

CompletedNCT04369586

A Phase I Clinical Trial of Meplazumab in Healthy Volunteer

A Single Center, Double-blinded, ,Placebo-controlled Phase I Clinical Trial in Healthy Volunteer to Evaluate Tolerance and Pharmacokinetics of Meplazumab of Injection

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
59 (actual)
Sponsor
Xijing Hospital · Academic / Other
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGmeplazumab for injectionsingle dose: 6 dose level, multiple dose: 0.3mg/kg/dose
DRUGPlaceboplacebo

Timeline

Start date
2020-04-25
Primary completion
2020-08-18
Completion
2020-11-20
First posted
2020-04-30
Last updated
2021-04-09

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT04369586. Inclusion in this directory is not an endorsement.