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A Clinical Study to Evaluate MW33 Injection

NCT04533048 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2021-02-26

No results posted yet for this study

Summary

This randomized, double-blind, placebo-controlled, single-dose escalation trial will be conducted to evaluate the safety, tolerability, immunogenicity, pharmacokinetic and pharmacodynamic characteristics of a single dose of MW33 injection at different doses given to healthy subjects to provide a basis for exploration of the therapeutic and preventive effects of MW33 against neocoronavirus in human.

Conditions

  • Covid19

Interventions

COMBINATION_PRODUCT

MW33 injection

a recombinant fully human antibody to coronavirus

COMBINATION_PRODUCT

MW33 injection placebo

Placebo

Sponsors & Collaborators

  • Shanghai Public Health Clinical Center

    collaborator OTHER_GOV

  • Mabwell (Shanghai) Bioscience Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2020-08-07
Primary Completion
2020-11-16
Completion
2020-12-02

Countries

  • China

Study Locations

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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 NCT04533048 on ClinicalTrials.gov