A Clinical Study to Evaluate MW33 Injection

NCT04533048 | Completed Phase 1

• 1 other identifier: MW33-2020-CP101
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Adverse Event

  safety evaluation

  12 weeks

• Serious Adverse Event

  safety evaluation

  12 weeks

Study Arms (2)

MW33

EXPERIMENTAL

Combination Product: MW33 injection

Placebo

EXPERIMENTAL

Combination Product: MW33 injection placebo

Interventions

MW33 injection COMBINATION_PRODUCT

a recombinant fully human antibody to coronavirus

MW33

MW33 injection placebo COMBINATION_PRODUCT

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects are fully aware of the purpose, nature, methods and possible adverse reactions of the study, voluntarily serve as subjects, and sign the informed consent form before the start of any study procedures, and ensure that he/she will participate in any procedures in the study in person;
• Subjects are able to communicate well with the investigator and understand and comply with the requirements of the study;
• The subject has no history of chronic or serious diseases involving the cardiovascular, liver, kidney, respiratory, blood and lymphatic, endocrine, immune, psychiatric, neurological, gastrointestinal system, and has a good general health condition;
• Subjects (including male subjects) do not have a pregnancy plan, voluntarily take effective contraceptive measures during the screening period and the next 6 months, and have no sperm and egg donation plans, and shall voluntarily take non-pharmaceutical contraception measures during the trial period;
• Male or female subjects aged 18 to 45 years (including 18 and 45 years);
• Weight ≥ 50.0 kg for males, or weight ≥ 45.0 kg for females, and body mass index (BMI) in the range of 19.0 \~ 26.0 kg/m2 (including cut-off value);
• Vital signs, physical examination, clinical laboratory tests (hematology, urinalysis, blood biochemistry, blood transfusion, coagulation function, pregnancy test \[female\], alcohol and drug screening, etc.), 12-lead electrocardiogram, chest X-ray and abdominal B-ultrasonography show no abnormalities or abnormalities without clinical significance.

You may not qualify if:

• Health status: clinically significant histories of heart, liver, kidney, digestive tract, nervous system, respiratory system, blood and lymphatic system, immune system, mental, metabolic, and bone abnormalities.
• Subjects who have a history of allergies to biological agents or any drug components; those who have a history of allergies and judged by the investigator to be ineligible for enrollment.
• Those who have undergone surgery within 3 months prior to screening, or who plan to undergo surgery during the study, or who have undergone surgery that affects drug absorption, distribution, metabolism, and excretion.
• Those who cannot tolerate venipuncture or have a history of needle-sickness and blood-sickness.
• Those who have a history of drug abuse within 6 months prior to screening.
• Use of illicit drugs within 3 months prior to screening.
• Those who donated blood within 3 months prior to screening (including component blood), or massive blood loss (≥ 200 mL), or blood transfusions or use of blood products.
• Subject (female) who is pregnant or lactating at screening or during the trial.
• Subjects have a fertility plan or sperm or egg donation plan at screening and within the next 6 months.
• Use of any prescription, over-the-counter, or Chinese herbal medicines within 2 weeks prior to screening.
• Those who have been vaccinated within 4 weeks prior to screening or who are scheduled to be vaccinated during the study.
• Those who have smoked more than 5 cigarettes per day within 3 months prior to screening, or who cannot stop using any tobacco products during the trial.
• Those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits containing 40% alcohol or 150 mL of wine) within 3 months prior to screening, or who cannot abstain from alcohol during the trial.
• Those who have special dietary requirements and cannot accept a standard diet.
• Those who have participated in drug clinical trials and used investigational drugs within 3 months prior to screening.

Sponsors & Collaborators

• Mabwell (Shanghai) Bioscience Co., Ltd.: lead
• Shanghai Public Health Clinical Center: collaborator

Study Sites (1)

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Location

Related Publications (2)

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

  PMID: 34473343 DERIVED

• Meng X, Wang P, Xiong Y, Wu Y, Lin X, Lu S, Li R, Zhao B, Liu J, Zeng S, Zeng L, Wu Y, Lu Y, Zhang J, Liu D, Wang S, Lu H. Safety, tolerability, pharmacokinetic characteristics, and immunogenicity of MW33: a Phase 1 clinical study of the SARS-CoV-2 RBD-targeting monoclonal antibody. Emerg Microbes Infect. 2021 Dec;10(1):1638-1648. doi: 10.1080/22221751.2021.1960900.

  PMID: 34346827 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2020
• First Posted: August 31, 2020
• Study Start: August 7, 2020
• Primary Completion: November 16, 2020
• Study Completion: December 2, 2020
• Last Updated: February 26, 2021

Record last verified: 2021-02

Locations

CN (1)