Status:
COMPLETED
JS016 (Anti-SARS-CoV-2 Monoclonal Antibody)With Mild and Moderate COVID-19 or SARS-CoV-2 Asymptomatic Infection Subects
Lead Sponsor:
Shanghai Junshi Bioscience Co., Ltd.
Conditions:
COVID-19
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
JS016-002-Ib/II is a randomized, double-blinded, placebo-controlled study, to investigate the safety, PK profiles, preliminary efficacy and immunogenicity of intravenous Recombinant Human Anti-SARS-Co...
Detailed Description
"Each participant will receive JS016 or matched placebo intravenous infusion on D1 (randomizing day). Non-pharmaceutical supportive background therapy (e.g. oxygen inhalation) for COVID-19 is allowed ...
Eligibility Criteria
Inclusion
- Age of 18-65 years (inclusive) ,women or man
- SARS-CoV-2 detected in the diagnostic specimen (nasopharyngeal swab)
- High homology of viral gene sequencing with the known SARS-CoV-2."
- Mild/moderateillness COVID-19 or SARS-CoV-2 asymptomatic infection
- Within 7 days from the onset time of symptoms to randomization or within 5 days from the first time of SARS-CoV-2 positive test to randomization with required viral load
- No plan of pregnancy and being willing to use effective contraceptive measures
- Signed the informed consent form, sufficiently understanding of the content
Exclusion
- positive IgM/IgG against SARS-CoV-2 prior to randomization.
- Severeor critical illness
- Uncontrolled hypertension, cardiovascular/cerebrovascular diseases,lung diseases
- Type 1 diabetes, or newly diagnosed or poorly controlled type 2 diabetes
- Liver and kidney dysfunction, immune or inflammatory diseases, infections, surgery, tumors, and other major diseases
- History of SARS-CoV-2 vaccination or participation in clinical trial with neutralizing antibody against SARS-CoV-2.
- Use of therapeutic biologics within 3 months prior to screening, or within the elimination period (5 half-lives) of such drugs as the day of dosing
- Has participated in any other interventional clinical study involving anstudy drug within 3 months prior to screening, or within the elimination period (5 half-lives) of the study drug as the day of dosing
- Platelets and hemoglobin test results during screening period are abnormal and have clinical significanc.
- Anaphylaxis, urine drug screening, alcohol dependence, lactation during pregnancy, blood loss, and others
Key Trial Info
Start Date :
October 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2021
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04780321
Start Date
October 30 2020
End Date
August 31 2021
Last Update
July 18 2022
Active Locations (2)
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1
Beijing Ditan Hospital affiliated to Capital Medical University
Beijing, China, 100010
2
Huashan Hospital affiliated to Fudan University
Shanghai, China