A Phase 1/2 interventional study of Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody(25mg/kg;50mg/kg;100mg/kg) and Placebo in COVID-19, sponsored by Shanghai Junshi Bioscience Co., Ltd.. Completed at 2 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-07-18.
Sponsored by Shanghai Junshi Bioscience Co., Ltd. · Phase 1/2, Interventional, and Treatment
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.
"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.
7,775 studies on the registry are indexed under COVID-19; 482 are open to participants now.
This study's enrollment of 62 is below the median of 100 across 4,175 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Shanghai Junshi Bioscience Co., Ltd. is the lead sponsor of 100 studies on the registry; 20 are open to participants now.
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Exclusion Criteria:
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 placebo to treat COVID-19
Drug: Placebo
use dose 1/2/3 60 patients receipt JS016 intravenous infusion on day 1
30 patients receipt placebo intravenous infusion on day 1
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
Time frame: 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
Time frame: 0-85days
PK Measures:AUC0-tau
Area under the plasma drug concentration-time curve from time 0 to one dosing interval (AUC0-tau)
Time frame: Day 0 to Day 85
PK Measures：Cmax
Maximum plasma drug concentration after administration (Cmax)
Time frame: Day 0 to Day 85
PK Measures：Tmax
Time to the maximum plasma drug concentrations after administration (Tmax)
Time frame: Day 0 to Day 85
PK Measures：t1/2
Terminal half life (t1/2)
Time frame: Day 0 to Day 85
PK Measures：CL
Total clearance (CL)
Time frame: Day 0 to Day 85
PK Measures：Vd
Apparent volume of distribution (Vd)
Time frame: Day 0 to Day 85
Proportions of participants with negative conversion in viral nucleic acid test
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)
Time frame: Day 0 to Day 85
Viral load change from baseline
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)
Time frame: Day 0 to Day 85
Pulmonary CT（observe by imaging reports to degree of pulmonary inflammation, degree of vitreous fibrosis)
Pulmonary CT changes during the study period
Time frame: Day 0 to Day 85
This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.
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Shanghai Junshi Bioscience Co., Ltd. →