NCT04533048

A Clinical Study to Evaluate MW33 Injection

Completed Phase 1 Last updated 26 February 2021

What this trial tests

Phase 1 trial testing MW33 injection in Covid19 in 42 participants. Completed in 2 December 2020.

Timeline

7 August 2020

Primary endpoint
16 November 2020

2 December 2020

Quick facts

Lead sponsor	Mabwell (Shanghai) Bioscience Co., Ltd.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	42
Start date	7 August 2020
Primary completion	16 November 2020
Estimated completion	2 December 2020
Sites	1 location across China

Drugs / interventions tested

• MW33 injection
• MW33 injection placebo

Conditions studied

• Covid19 — all drugs for Covid19 →

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd. — full company profile →

Who can join

Adults 18 to 45, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neutralizing monoclonal antibodies for treatment of COVID-19.
   Taylor PC, Adams AC, Hufford MM, de la Torre I, et al · · 2021 · cited 604× · PMID 33875867 · DOI 10.1038/s41577-021-00542-x
2. Monoclonal antibodies for COVID-19 therapy and SARS-CoV-2 detection.
   Hwang YC, Lu RM, Su SC, Chiang PY, et al · · 2022 · cited 170× · PMID 34983527 · DOI 10.1186/s12929-021-00784-w
3. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19.
   Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, et al · · 2021 · cited 126× · PMID 34473343 · DOI 10.1002/14651858.cd013825.pub2
4. Anti-SARS-CoV-2 neutralizing monoclonal antibodies: clinical pipeline.
   Tuccori M, Ferraro S, Convertino I, Cappello E, et al · · 2020 · cited 124× · PMID 33319649 · DOI 10.1080/19420862.2020.1854149
5. A Detailed Overview of Immune Escape, Antibody Escape, Partial Vaccine Escape of SARS-CoV-2 and Their Emerging Variants With Escape Mutations.
   Chakraborty C, Sharma AR, Bhattacharya M, Lee SS. · · 2022 · cited 112× · PMID 35222380 · DOI 10.3389/fimmu.2022.801522
6. Neutralizing antibodies targeting SARS-CoV-2 spike protein.
   Xiaojie S, Yu L, Lei Y, Guang Y, et al · · 2021 · cited 99× · PMID 33341604 · DOI 10.1016/j.scr.2020.102125
7. COVID-19 update: The race to therapeutic development.
   Twomey JD, Luo S, Dean AQ, Bozza WP, et al · · 2020 · cited 50× · PMID 33161277 · DOI 10.1016/j.drup.2020.100733
8. Emerging antibody-based therapeutics against SARS-CoV-2 during the global pandemic.
   Sun Y, Ho M. · · 2020 · cited 36× · PMID 33912795 · DOI 10.1093/abt/tbaa025