COVID-19 trials registries data warehouse

http://www.chictr.org.cn/showproj.aspx?proj=66096

Zhang Ying

zhangying@jemincare.com

2021-01-14

Not recruiting

RCT

Randomized

Parallel

Blind label

single-center

Prevention

1. Male and female subjects aged 18 to 45 years, inclusive, 2. The body weight no less than 50 kg for male subjects and no less than 45 kg for female subjects. Body mass index (BMI) = weight (kg)/square of height (m2), ranging from 18-28 kg/m2 (including the critical value), 3. These indicators are normal including physical examination, vital signs, laboratory tests and other accessory examinations (chest radiology, abdominal B-mode ultrasonography, ECG, etc.), or above indicators are aberrant but clinically insignificant, 4. No plan of pregnancy and being willing to use effective contraceptive measures for subject (including partner) from informed consent to 6 months after administration of investigational product, see Appendix 5 for the specific contraceptive measures, 5. The subjects are able to understand the content of the study and voluntary to sign the informed consent form, meanwhile, being able to complete the study as required in the protocol.

1.Patients who have been diagnosed with Covid-19 cases and suspected cases, have a history of contact with confirmed cases and suspected cases of new coronavirus in 14 days before signing the informed consent form, or have SARS-COV-2 infection or carriers, 2.Having diseases history of cardiovascular system, respiratory system, digestive system, endocrine system (diabetes mellitus), nervous/mental system (mental or physical disability), blood and lymphatic system (immune system deficiency), musculoskeletal system and other diseases confirmed by the investigator, 3.Any of the test results are positive, including Hepatitis B surface antigen (HBsAg), hepatitis B E antigen (HBeAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV), treponema Pallida antibody (TP-AB) 4.Those who are known to have rapid or delayed hypersensitivity to the drugs or ingredients, or have allergic constitution or other allergic diseases (asthma, urticaria, eczema dermatitis, etc.), or are known to be allergic to protein products, 5.Those who have received vaccine within 3 months before screening or have any vaccination program during the clinical trial. 6.Those who received chemotherapy, radiotherapy, immunosuppressive therapy or high-dose corticosteroid therapy within 5 years before screening, 7.Those who have taken any non-prescription drugs, prescription drugs, Traditional Chinese medicine or vitamins within 1 month before screening, 8.Those who have had surgery in the previous 6 months or planned operation during the trial period, 9.Those who have drug abuse history or positive urine drug screening in the previous 12 months, 10.Frequent drinkers who drink more than 14 units of alcohol per week (1 unit = 360 mL of beer or 45 mL of 40% spirits or 150 mL of wine), or fail to guarantee that they will abstain from drinking during the test period, or alcohol breath test is positive in the previous 6 months before screening, 11.Smokers who had smoked at least 5 cigarettes per day in the first 3 months before screening or could not guarantee to give up smoking during the test period, 12.Those who have participated in other drug clinical trials in the previous 3 months (the last visit of the last trial was calculated as the starting time) before screening, 13.Those whose blood donation or blood loss >= 450ml within 3 months before screening, 14.Those who have received >= 2 units of blood products in the first 3 months before screening, 15.Those who do not agree to avoid the use of tobacco, alcohol or caffeinated drinks within 24 hours before and during the trial, or avoid strenuous exercise, or other factors affecting drug absorption, distribution, metabolism, and excretion, 16.Women who are pregnant or breastfeeding, or whose pregnancy test results are positive before the test, Male or female subjects who are unable or fail to use a medically approved non-drug contraceptive method during the study period as requested by the Investigator, or who have a sperm/egg donor program (from the date of signing the informed consent form until 1 month after the study), 17.Having difficulty in vein blood collection or being dizzy with dizziness, 18.Those who have special dietary requirements, fail to comply with the provided diet and corresponding regulations, cannot avoid drinks containing xanthine (coffee, tea, etc.) or foods (liver of animals) during the study period, or cannot avoid eating grapefruit, grapefruit, mango and other fruits or jui

4

Shu Lan (Hang Zhou) Hospital

18

45

China

Healthy volunteers

N/A

40

safety; tolerability; pharmacokinetic profile and immunogenicity;AE/SAE;Cmax;AUC0-inf;AUC0-t;Tmax;t1/2;MRT;?z;CL;Vz;Total positive rate of anti-drug antibodies;The positive proportion of anti-drug antibodies at different test times;nutralizing ability of anti-drug antibodies for JMB2002;

| Declared number of arm (4.0) differs from found arms (5.0)

Phase 1

[{"arm_notes": "5mg/Kg", "treatment_id": 699, "treatment_name": "Jmb2002", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "15mg/Kg", "treatment_id": 699, "treatment_name": "Jmb2002", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "30mg/Kg", "treatment_id": 699, "treatment_name": "Jmb2002", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "50mg/Kg", "treatment_id": 699, "treatment_name": "Jmb2002", "treatment_type": "Monoclonal antibodies", "pharmacological_treatment": "Pharmacological treatment"}]