Back to resultsA Study of JS026 and JS026 Together With JS016 for Treatment of COVID-19
Primary Purpose
COVID-19
Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
JS026/placebo
JS016/placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Male or female healthy subjects
- Body weight ≥ 50 kg for males and ≥ 45 kg for females
- Female subjects must meet the following criteria: not of childbearing potential (e.g., documented hysterectomy, bilateral salpingectomy or ligation, or more than 1 year of amenorrhea), or of childbearing potential with a negative blood pregnancy test at screening, and willing to take strict and effective contraceptive measures (e.g., abstinence, medication, or barrier method [e.g., contraceptive sponge, vaginal cuff, vaginal diaphragm, cervical cap, etc.]) for 6 months after dosing. Male subjects must agree to take strict and effective contraceptive measures (eg, abstinence, drug, or barrier method [e.g., male condom]) for 6 months after dosing.
- Results of medical evaluations, including physical examination, vital signs, laboratory tests, and other auxiliary examinations (chest imaging, abdominal B ultrasound, ECG, etc.) are normal or abnormal without clinical significance.
- Able to read and understand the contents of the trial, willing to participate in the trial and comply with the trial protocol and procedures, and having signed the written ICF.
Exclusion Criteria:
- Patients with past medical history or current clinically significant concomitant diseases;
- History of malignancies within 5 years.
- Receiving any prescription drugs or over-the-counter drugs, including herbal remedies, vitamins, and dietary supplements, within 14 days prior to screening.
- Participating in any clinical trial with drug intervention within 3 months prior to screening, or the drug is within the elimination phase (5 elimination half-lives), whichever is longer.
- Receiving any therapeutic or investigational biologic within 6 months prior to screening.
- With a history of drug abuse within 1 year, or a positive result at screening.
- Females who are pregnant or lactating.
- Any other condition that the investigator deems inappropriate to participate in the trial, such as subject's mental or legal incapacity, potential compliance problems, and failure to complete the study-related procedures according to the requirements of the protocol, as determined by the investigator.
Sites / Locations
- Huashan Hospital affiliated to Fudan University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Placebo Comparator
Arm Label
JS026/placebo 30 mg
JS026/placebo 100 mg
JS026/placebo 300 mg
JS026/placebo 600 mg
JS026/placebo 1000 mg
JS026/placebo 300 mg + JS016/placebo1200 mg
JS026/placebo 600 mg + JS016/placebo 1200 mg
Arm Description
4 patients will be enrolled in this arm.
4 patients will be enrolled in this arm.
8 patients will be enrolled in this arm.
8 patients will be enrolled in this arm.
8 patients will be enrolled in this arm.
8 patients will be enrolled in this arm.
8 patients will be enrolled in this arm.
Outcomes
Primary Outcome Measures
Safety: Incidence and severity of any adverse events (AEs) occurring during the clinical trial per CTCAE V5.0
Incidence and severity of any adverse events (AEs) occurring during the clinical trial, including serious adverse events (SAEs), and adverse events of special interest (AESIs), as well as abnormalities in clinical symptoms, vital signs, physical examination, laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs will be observed for all the subjects, the their clinical manifestations and features, severity, time to onset, end time, therapeutic measures and outcomes will be recorded, and the correlation of the adverse events with the investigational product will be judged.
Secondary Outcome Measures
Pharmacokinetics: AUC
Area under the plasma concentration-time curve from the time of dosing to the last measurable concentration time t (AUC0-last)
Pharmacokinetics: Tmax
Time to maximum concentration (Tmax)
Pharmacokinetics: Cmax
Maximum concentration (Cmax)
Pharmacokinetics: Vd
Apparent volume of distribution (Vd)
Pharmacokinetics: CLt
Terminal clearance (CLt)
Pharmacokinetics: t1/2
Elimination half-life (t1/2)
Immunogenicity: ADA
Incidence of anti-drug antibodies (ADA)
Full Information
NCT ID
NCT05167279
First Posted
December 13, 2021
Last Updated
July 27, 2023
Sponsor
Shanghai Junshi Bioscience Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05167279
Brief Title
A Study of JS026 and JS026 Together With JS016 for Treatment of COVID-19
Official Title
A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetic Profiles, and Immunogenicity of JS026 and JS026 in Together With JS016 Administered Intravenously to Healthy Chinese Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
December 16, 2021 (Actual)
Primary Completion Date
December 8, 2022 (Actual)
Study Completion Date
December 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Junshi Bioscience Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This is a first-in-human (FIH), randomized, double-blind, placebo-controlled, single-center phase I clinical trial of JS026 and JS026 + JS016 Injection. The objective of the study is to evaluate the safety, tolerability, PK profile and immunogenicity of a single intravenous infusion of JS026 and JS026 + JS016 Injection in healthy subjects.
In this study, the single ascending dose design will be adopted, JS026 will be administered sequentially from low dose group to high dose group, and each subject can only receive an intravenous infusion at one dose level. Five dose groups (30 mg, 100 mg, 300 mg, 600 mg, and 1000 mg) will be set to receive an intravenous infusion of JS026, and two dose groups (300 mg JS026 + 1200 mg JS016, and 600 mg JS026+ 1200 mg JS016) will be set for JS026 + JS016. The investigational product and placebo will be distributed in each dose group in a ratio of 3:1. Four subjects will be enrolled in each of JS026 30 mg and 100 mg groups, and 8 subjects will be enrolled in each of other dose groups, totally 48 subjects.
Detailed Description
The entire trial period consists of a screening period of up to 14 days, a single dosing day (D1), and a 12-week follow-up period (84 days after dosing). Subjects will be admitted to the phase I clinical trial ward on the day before administration (D-1), and discharged after all examinations and assessments are completed on D4 after administration. Moreover, they will return to thestudy site for follow-up visits and relevant procedures and assessments as scheduled in the protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
JS026/placebo 30 mg
Arm Type
Placebo Comparator
Arm Description
4 patients will be enrolled in this arm.
Arm Title
JS026/placebo 100 mg
Arm Type
Placebo Comparator
Arm Description
4 patients will be enrolled in this arm.
Arm Title
JS026/placebo 300 mg
Arm Type
Placebo Comparator
Arm Description
8 patients will be enrolled in this arm.
Arm Title
JS026/placebo 600 mg
Arm Type
Placebo Comparator
Arm Description
8 patients will be enrolled in this arm.
Arm Title
JS026/placebo 1000 mg
Arm Type
Placebo Comparator
Arm Description
8 patients will be enrolled in this arm.
Arm Title
JS026/placebo 300 mg + JS016/placebo1200 mg
Arm Type
Placebo Comparator
Arm Description
8 patients will be enrolled in this arm.
Arm Title
JS026/placebo 600 mg + JS016/placebo 1200 mg
Arm Type
Placebo Comparator
Arm Description
8 patients will be enrolled in this arm.
Intervention Type
Biological
Intervention Name(s)
JS026/placebo
Intervention Description
Five dose groups (30 mg, 100 mg, 300 mg, 600 mg, and 1000 mg) will be set to receive an intravenous infusion of JS026/placebo on Day1, and two dose groups (300 mg JS026 + 1200 mg JS016, and 600 mg JS026+ 1200 mg JS016) will be set to receive an intravenous infusion of JS026/placebo + JS016/placebo on Day1. The investigational product and placebo will be distributed in each dose group in a ratio of 3:1.
Intervention Type
Biological
Intervention Name(s)
JS016/placebo
Intervention Description
Two dose groups (300 mg + 1200 mg, and 600 mg + 1200 mg) will be set to receive an intravenous infusion of JS026/placebo + JS016/placebo on Day1. The investigational product and placebo will be distributed in each dose group in a ratio of 3:1.
Primary Outcome Measure Information:
Title
Safety: Incidence and severity of any adverse events (AEs) occurring during the clinical trial per CTCAE V5.0
Description
Incidence and severity of any adverse events (AEs) occurring during the clinical trial, including serious adverse events (SAEs), and adverse events of special interest (AESIs), as well as abnormalities in clinical symptoms, vital signs, physical examination, laboratory tests (complete blood cell count, serum chemistry, routine urinalysis, coagulation function, etc.) and 12-lead ECGs will be observed for all the subjects, the their clinical manifestations and features, severity, time to onset, end time, therapeutic measures and outcomes will be recorded, and the correlation of the adverse events with the investigational product will be judged.
Time Frame
85 days
Secondary Outcome Measure Information:
Title
Pharmacokinetics: AUC
Description
Area under the plasma concentration-time curve from the time of dosing to the last measurable concentration time t (AUC0-last)
Time Frame
Day 1 to D85
Title
Pharmacokinetics: Tmax
Description
Time to maximum concentration (Tmax)
Time Frame
Day 1 to D85
Title
Pharmacokinetics: Cmax
Description
Maximum concentration (Cmax)
Time Frame
Day 1 to D85
Title
Pharmacokinetics: Vd
Description
Apparent volume of distribution (Vd)
Time Frame
Day 1 to D85
Title
Pharmacokinetics: CLt
Description
Terminal clearance (CLt)
Time Frame
Day 1 to D85
Title
Pharmacokinetics: t1/2
Description
Elimination half-life (t1/2)
Time Frame
Day 1 to D85
Title
Immunogenicity: ADA
Description
Incidence of anti-drug antibodies (ADA)
Time Frame
Day 1 to D85
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female healthy subjects
Body weight ≥ 50 kg for males and ≥ 45 kg for females
Female subjects must meet the following criteria: not of childbearing potential (e.g., documented hysterectomy, bilateral salpingectomy or ligation, or more than 1 year of amenorrhea), or of childbearing potential with a negative blood pregnancy test at screening, and willing to take strict and effective contraceptive measures (e.g., abstinence, medication, or barrier method [e.g., contraceptive sponge, vaginal cuff, vaginal diaphragm, cervical cap, etc.]) for 6 months after dosing. Male subjects must agree to take strict and effective contraceptive measures (eg, abstinence, drug, or barrier method [e.g., male condom]) for 6 months after dosing.
Results of medical evaluations, including physical examination, vital signs, laboratory tests, and other auxiliary examinations (chest imaging, abdominal B ultrasound, ECG, etc.) are normal or abnormal without clinical significance.
Able to read and understand the contents of the trial, willing to participate in the trial and comply with the trial protocol and procedures, and having signed the written ICF.
Exclusion Criteria:
Patients with past medical history or current clinically significant concomitant diseases;
History of malignancies within 5 years.
Receiving any prescription drugs or over-the-counter drugs, including herbal remedies, vitamins, and dietary supplements, within 14 days prior to screening.
Participating in any clinical trial with drug intervention within 3 months prior to screening, or the drug is within the elimination phase (5 elimination half-lives), whichever is longer.
Receiving any therapeutic or investigational biologic within 6 months prior to screening.
With a history of drug abuse within 1 year, or a positive result at screening.
Females who are pregnant or lactating.
Any other condition that the investigator deems inappropriate to participate in the trial, such as subject's mental or legal incapacity, potential compliance problems, and failure to complete the study-related procedures according to the requirements of the protocol, as determined by the investigator.
Facility Information:
Facility Name
Huashan Hospital affiliated to Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Study of JS026 and JS026 Together With JS016 for Treatment of COVID-19
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