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

NCT04780321 | Completed Phase 1

• 1 other identifier: JS016-002-Ib/II
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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.

Conditions

COVID-19

Outcome Measures

Primary Outcomes (2)

• Efficacy Measurs(Time to negative conversion in viral nucleic acid test(by RT-PCR) for diagnostic samples)

  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

  0-85days

• Safety Measurements : 90 of participants with treatment-related adverse events as assessed byCTCAE v5.0

  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

  0-85days

Secondary Outcomes (9)

• PK Measures:AUC0-tau

  Day 0 to Day 85

• PK Measures：Cmax

  Day 0 to Day 85

• PK Measures：Tmax

  Day 0 to Day 85

• PK Measures：t1/2

  Day 0 to Day 85

• PK Measures：CL

  Day 0 to Day 85

Study Arms (2)

Anti-SARS-CoV-2 Monoclonal Antibody dose 1/2/3

ACTIVE COMPARATOR

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)

Placebo

PLACEBO COMPARATOR

use placebo to treat COVID-19

Drug: Placebo

Interventions

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

Anti-SARS-CoV-2 Monoclonal Antibody dose 1/2/3

Placebo DRUG

30 patients receipt placebo intravenous infusion on day 1

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Junshi Bioscience Co., Ltd.: lead

Study Sites (2)

Beijing Ditan Hospital affiliated to Capital Medical University

Beijing, 100010, China

Location

Huashan Hospital affiliated to Fudan University

Shanghai, China

Location

Related Publications (1)

• Kreuzberger N, Hirsch C, Chai KL, Tomlinson E, Khosravi Z, Popp M, Neidhardt M, Piechotta V, Salomon S, Valk SJ, Monsef I, Schmaderer C, Wood EM, So-Osman C, Roberts DJ, McQuilten Z, Estcourt LJ, Skoetz N. SARS-CoV-2-neutralising monoclonal antibodies for treatment of COVID-19. Cochrane Database Syst Rev. 2021 Sep 2;9(9):CD013825. doi: 10.1002/14651858.CD013825.pub2.

  PMID: 34473343 DERIVED

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: March 3, 2021
• Study Start: October 30, 2020
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

CN (2)