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

Mabwell (Shanghai) Bioscience Co., Ltd.1 site in 1 country42 target enrollmentAugust 7, 2020

ConditionsCovid19

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Covid19
Sponsor: Mabwell (Shanghai) Bioscience Co., Ltd.
Enrollment: 42
Locations: 1
Primary Endpoint: Adverse Event
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 7, 2020

End Date

December 2, 2020

Last Updated

5 years ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Mabwell (Shanghai) Bioscience Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.