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Clinical Study of Meplazumab to Treat With Malaria

NCT04327310 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2023-09-21

No results posted yet for this study

Summary

This Phase 1 study will be conducted to explore the dose regimen in humans and to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and toxicological effects of meplazumab in healthy subjects, thus providing a new macromolecule antibody drug for the prevention and treatment of P. falciparum infection.

Conditions

  • Malaria (Plasmodium Falciparum)

Interventions

DRUG

Meplazumab for Injection

humanized mAb against CD147

DRUG

Sterile normal saline (0.9%)

Sterile normal saline (0.9%)

Sponsors & Collaborators

  • Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-31
Primary Completion
2023-12-31
Completion
2024-03-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04327310 on ClinicalTrials.gov