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JS016 (Anti-SARS-CoV-2 Monoclonal Antibody)With Mild and Moderate COVID-19 or SARS-CoV-2 Asymptomatic Infection Subects

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ClinicalTrials.gov Identifier: NCT04780321
Recruitment Status : Recruiting
First Posted : March 3, 2021
Last Update Posted : April 22, 2021
Sponsor:
Information provided by (Responsible Party):
Shanghai Junshi Bioscience Co., Ltd.

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-CoV-2 Monoclonal Antibody (JS016) in participants with mild and moderate COVID-19 or of SARS-CoV-2 Asymptomatic Infection.

Three doses of JS016 are to be investigated, including 25mg/kg, 50mg/kg and 100mg/kg, given as single dose of intravenous infusion. In total, 90 participants will be enrolled with 30 participants each for 25, 50 and 100mg/kg dose cohort at a ratio of 2:1 to receive investigational product or placebo treatment, respectively.


Condition or disease Intervention/treatment Phase
COVID-19 Biological: Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody(25mg/kg;50mg/kg;100mg/kg) Drug: Placebo Phase 1 Phase 2

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 per clinical needs.

Investigators will be kept blinded to review the preliminary efficacy and safety data on a regular basis. Meanwhile, a study evaluation team (SET) composed of medical monitors, safety assessors and statisticians will be set up to review the study status, safety and preliminary efficacy of the participants at the pre-specified time points or as necessary.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, Phase Ib/II Clinical Study to Evaluate the Preliminary Efficacy, Safety, Pharmacokinetic Profiles and Immunogenicity of JS016 in Participants With Mild and Moderate COVID-19 or of SARS-CoV-2 Asymptomatic Infection
Actual Study Start Date : October 30, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Anti-SARS-CoV-2 Monoclonal Antibody dose 1/2/3
use Anti-SARS-CoV-2 Monoclonal Antibody,dose 1/2/3 to treat COVID-19
Biological: Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody(25mg/kg;50mg/kg;100mg/kg)
use dose 1/2/3 60 patients receipt JS016 intravenous infusion on day 1

Placebo Comparator: Placebo
use placebo to treat COVID-19
Drug: Placebo
30 patients receipt placebo intravenous infusion on day 1




Primary Outcome Measures :
  1. Efficacy Measurs(Time to negative conversion in viral nucleic acid test(by RT-PCR) for diagnostic samples) [ Time Frame: 0-85days ]
    Time to negative conversion in viral nucleic acid test (by RT-PCR) for diagnostic samples, negative conversion is defined as two consecutive negative nucleic acid test for diagnostic samples after randomization

  2. Safety Measurements : 90 of participants with treatment-related adverse events as assessed byCTCAE v5.0 [ Time Frame: 0-85days ]
    Any adverse event, serious adverse events (SAEs) occurring during the clinical study, including clinical symptoms and abnormal vital signs, abnormal laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, myocardial enzymogram, etc.) and abnormality of 12-lead ECGs will be observed for all the participants


Secondary Outcome Measures :
  1. PK Measures:AUC0-tau [ Time Frame: Day 0 to Day 85 ]
    Area under the plasma drug concentration-time curve from time 0 to one dosing interval (AUC0-tau)

  2. PK Measures:Cmax [ Time Frame: Day 0 to Day 85 ]
    Maximum plasma drug concentration after administration (Cmax)

  3. PK Measures:Tmax [ Time Frame: Day 0 to Day 85 ]
    Time to the maximum plasma drug concentrations after administration (Tmax)

  4. PK Measures:t1/2 [ Time Frame: Day 0 to Day 85 ]
    Terminal half life (t1/2)

  5. PK Measures:CL [ Time Frame: Day 0 to Day 85 ]
    Total clearance (CL)

  6. PK Measures:Vd [ Time Frame: Day 0 to Day 85 ]
    Apparent volume of distribution (Vd)

  7. Proportions of participants with negative conversion in viral nucleic acid test [ Time Frame: Day 0 to Day 85 ]
    Proportions of participants with negative conversion in viral nucleic acid test 7 days and 14 days after administration (performed on each day of the first week after dosing, every other day of the 2nd week, once a week from the 3rd week)

  8. Viral load change from baseline [ Time Frame: Day 0 to Day 85 ]
    Viral load change from baseline (performed on each day of the first week after dosing, every other day of the 2nd week, once a week from the 3rd week)

  9. Pulmonary CT(observe by imaging reports to degree of pulmonary inflammation, degree of vitreous fibrosis) [ Time Frame: Day 0 to Day 85 ]
    Pulmonary CT changes during the study period



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of 18-65 years (inclusive) ,women or man
  2. SARS-CoV-2 detected in the diagnostic specimen (nasopharyngeal swab)
  3. High homology of viral gene sequencing with the known SARS-CoV-2."
  4. Mild/moderateillness COVID-19 or SARS-CoV-2 asymptomatic infection
  5. 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
  6. No plan of pregnancy and being willing to use effective contraceptive measures
  7. Signed the informed consent form, sufficiently understanding of the content

Exclusion Criteria:

  1. positive IgM/IgG against SARS-CoV-2 prior to randomization.
  2. Severeor critical illness
  3. Uncontrolled hypertension, cardiovascular/cerebrovascular diseases,lung diseases
  4. Type 1 diabetes, or newly diagnosed or poorly controlled type 2 diabetes
  5. Liver and kidney dysfunction, immune or inflammatory diseases, infections, surgery, tumors, and other major diseases
  6. History of SARS-CoV-2 vaccination or participation in clinical trial with neutralizing antibody against SARS-CoV-2.
  7. 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
  8. 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
  9. Platelets and hemoglobin test results during screening period are abnormal and have clinical significanc.
  10. Anaphylaxis, urine drug screening, alcohol dependence, lactation during pregnancy, blood loss, and others

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04780321


Contacts
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Contact: jingjing sheng 17317890616 jingjing_sheng@junshipharma.com

Locations
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China
Beijing Ditan Hospital affiliated to Capital Medical University Not yet recruiting
Beijing, China, 100010
Contact: Fujie Zhang, MD    010-84322581    treatment@chinaaids.cn   
Huashan Hospital affiliated to Fudan University Recruiting
Shanghai, China
Contact: Wenhong Zhang, MD    021-52889305    yurancao@126.com   
Contact: Jing zhang, MD         
Sponsors and Collaborators
Shanghai Junshi Bioscience Co., Ltd.
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Responsible Party: Shanghai Junshi Bioscience Co., Ltd.
ClinicalTrials.gov Identifier: NCT04780321    
Other Study ID Numbers: JS016-002-Ib/II
First Posted: March 3, 2021    Key Record Dates
Last Update Posted: April 22, 2021
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Asymptomatic Infections
Asymptomatic Diseases
Disease Attributes
Pathologic Processes
Antibodies
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs