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NCT Number: NCT04780321

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Ditan Hospital affiliated to Capital Medical University, Beijing, China

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About this study

"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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody(25mg/kg;50mg/kg;100mg/kg)

Biological

use dose 1/2/3 60 patients receipt JS016 intravenous infusion on day 1

Placebo

Drug

30 patients receipt placebo intravenous infusion on day 1

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd.

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2021
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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