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Covid19Phase 1NCT04533048

A Clinical Study to Evaluate MW33 Injection

A Phase 1 study testing MW33 injection in people with Covid19, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Covid19
What is being tested?
MW33 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
42 participants
Where
1 siteChina
Study dates
7 Aug 2020to 2 Dec 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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.
  • Those who have previously used immunosuppressants or monoclonal antibodies for any reason.
  • Those with abnormal vital signs with clinical significance based on reference normal range (including cut-off values): sitting systolic blood pressure 90-139 mmHg, diastolic blood pressure 60-89 mmHg, pulse 60-100 beats/min, body temperature (ear temperature) 35.4-37.7 °C, respiration 16-20 breaths/min. The specific situation will be comprehensively determined by the investigator.
  • Those with abnormalities in laboratory tests and auxiliary examinations that are judged by the investigator to be clinically significant.
  • Those who have one or more clinically significant tests of hepatitis B virological markers, hepatitis C virus antibodies, anti-human immunodeficiency virus antibodies, or anti-Treponema pallidum-specific antibodies.
  • Female subjects with a positive urine or blood pregnancy test at screening.
  • Alcohol breath test results greater than 0.0 mg/100 ml or positive drug screening (morphine, icenarcotics [methamphetamine], ketamine, ecstasy [methylenedioxyamphetamine], cannabis [tetrahydrocannabinolate]).
  • Those who have acute illness from screening to day -1 admission.
  • Those who have taken any prescription, over-the-counter, Chinese herbal medicines from screening to day -1 admission.
  • Subjects who is inappropriate to participate in the trial due to any reasons as determined by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shanghai Public Health Clinical Center

    Shanghai, Shanghai Municipality

Other trials in China

About this study

Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Immunogenicity of a Single Dose of MW33 Injection in Healthy Subjects

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
Being tested
MW33 injection, MW33 injection placebo
Medical subject headings
COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MW33 injectionCombination product

    a recombinant fully human antibody to coronavirus

  • MW33 injection placeboCombination product

    Placebo

Study groups in NCT04533048
Study groupRoleWhat they receive
MW33ExperimentalNot described
Receives: Combination Product: MW33 injection
PlaceboExperimentalNot described
Receives: Combination Product: MW33 injection placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Event

    safety evaluation

    Measured: 12 weeks

  2. Serious Adverse Event

    safety evaluation

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Aug 2020
  2. Study start7 Aug 2020
  3. Primary completion16 Nov 2020
  4. Study completion2 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
42 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04533048
Sponsor's protocol ID
MW33-2020-CP101
Status last verified
Feb 2021
First submitted
22 Aug 2020
Last updated
26 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 34473343

  • 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.

    PubMed 34346827

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MW33 injection in people with Covid19, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Event (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04533048, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.

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