COVID-19; and High Infection Risk of SARS-CoV-2Phase 1NCT04441918
Tolerability,Safety,Pharmacokinetic Profile and Immunogenicity of a Recombinant Humanized Anti-SARS-CoV-2 Monoclonal Antibody (JS016) for Injection in Chinese Health Subjects
A Phase 1 study testing JS016 (anti-SARS-CoV-2 monoclonal antibody) in people with COVID-19; and High Infection Risk of SARS-CoV-2, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, double-blind, placebo-controlled, phase I clinical study to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of JS016 (anti-SARS-CoV-2 monoclonal antibody) injection in Chinese healthy subjects after intravenous infusion of single dose.Eligible patients will be… Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19; and High Infection Risk of SARS-CoV-2
- What is being tested?
- JS016 (anti-SARS-CoV-2 monoclonal antibody)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2020to 11 Dec 2020
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Male and female subjects aged 18 to 45 years, inclusive;
- The body weight no less than 50 kg for male subjects and no less than 45 kg for female subjects. Body mass index (BMI) = weight (kg)/square of height (m2), ranging from 18-28 kg/m2 (including the critical value);
- Normal or abnormal but clinically insignificant physical examination, vital signs, laboratory tests and other accessory examinations (chest radiology, abdominal B-mode ultrasonography, ECG, etc.);
- No plan of pregnancy and being willing to use effective contraceptive measures for subject (including partner) from informed consent to 6 months after administration of investigational product, see Appendix 5 for the specific contraceptive measures;
- The subjects are able to understand the content of the study and voluntary to sign the informed consent form; meanwhile, being able to complete the study as required in the protocol.
Who cannot join
- Excluded for novel coronavirus (SARS-CoV-2) infection
- Having one of the following evidence on SARS-CoV-2 infection:
- SARS-CoV-2 determined by reverse transcription-polymerase chain reaction (RT-PCR) and/or next generation sequencing (NGS) in diagnostic specimens (nasopharyngeal swabs) during screening and pre-randomization (results within 3 days before randomization are accepted);
- Previous viral gene sequencing showed high homology with the known SARS-CoV-2;
- Positive specific antibody IgM or IgG against serum SARS-CoV-2; Excluded for previous and concomitant medications
- Previous vaccination of SARS-CoV-2 vaccine or having participated in the clinical trial on SARS-CoV-2 neutralizing antibody;
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- Use of therapeutic biologics within 12 weeks prior to screening, or remaining in the elimination period of the drug (within 5 half-lives) at random administration, whichever is longer;
- Participation in any other clinical study with intervention of investigational product within 4 weeks prior to screening, or remaining in the elimination period of the drug (within 5 half-lives) prior to screening, whichever is longer;
- Vaccination of vaccine within 12 weeks prior to screening, or plan to use Bacille Calmette-Guérin vaccine or other vaccine during the study and within 12 weeks after the study;
- Use of hydroxychloroquine, herbal medicine, any prescription drug or over-the-counter drug within (inclusive) 14 days prior to screening; Surgery
- Any major surgery within 8 weeks (inclusive) prior to screening, or requiring such surgery during the study, and such surgery is considered by the investigator to possibly bring unacceptable risk for subjects upon confirmation with the sponsor; Abnormal physical examination, laboratory examination and history
- Lying systolic blood pressure (SBP) > 140 mmHg or < 90 mmHg, and/or diastolic blood pressure (DBP) > 90 mmHg or < 50 mmHg at screening and randomization;
- Total white blood cell (WBC) count < 3.5 x 109/L, platelet < 140 x 109/L, neutrophil < 2.0 x 109/L, or hemoglobin decreased (male < 135 g/L, female < 120 g/L), lymphocytes < 1.0 x 109/L at screening;
- ALT or AST > 2 × upper limit of normal, or eGFR ≤ 90 mL/min/1.73m2 at screening;
- Abnormal ECG at screening, single QTcF > 450 msec, and/or other abnormalities of clinical significance, unacceptable risk that may be brought by participation in the study;
- History of HIV infection, and/or positive aiti-HIV antibody, positive hepatitis B surface antigen (HBsAg), positive hepatitis C antibody (anti-HCV), or positivetreponema pallidum particle agglutination test (TPPA) at screening;
- History of transplantation of vital organs (e.g., heart, lung, liver, kidney, etc.);
- Having malignant tumor (excluding the malignant tumor cured with no recurrence in the past 5 years, completely resected basal cell and squamous cell carcinoma of skin, completely resected carcinoma in situ of any type);
- Other major diseases within one year;
- Medical history and previous history suggest the following diseases: including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immune, mental or cerebro- and cardiovascular diseases; Substance abuse, alcohol abuse
- History of drug abuse or use of narcotics in the past 5 years, or positive urine drug screening;
- History of alcohol abuse or intake of excessive alcohol in the past 6 months (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL liquor, or 100 mL wine), or alcohol test positive; History of allergies
- Known serious allergic reaction or hypersensitive to food, inhaled and contact material as well as drugs, or allergic constitution (allergy to various drugs and food);
- Known history of allergy or hypersensitivity to the investigational drug, other monoclonal antibody drugs and therapeutic protein preparations (fresh or frozen plasma, human serum albumin, cytokine, interleukin etc.); Pregnancy, lactation
- Positive β-Human Chorionic Gonadotropin (β-HCG) or breastfeeding female subjects; Blood loss and others
- Subjects who lost blood or donated more than 400 mL, or received blood transfusion in the past 3 months; or plan to donate blood during the study;
- Any other condition that the subject is considered by the investigator as inappropriate to participate in the study, for example, potential compliance issue, inability to complete all the tests and evaluations according to the requirements in the protocol, or uncontrolled mental, neurological or psychological disorders, participation in the study is judged by the investigator to be associated with uncontrollable risk.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital affiliated to Fudan University
Shanghai
Jing Zhang, 02152888189 ext. 02152888189, 13816357098@163.com
Wenhong Zhang, 02152888123 ext. 02152888123, zhangwenhong@fudan.edu.cn
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Phase I Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetic Profile and Immunogenicity of JS016 (Anti-SARS-CoV-2 Monoclonal Antibody) Injection in Chinese Healthy Subjects After Intravenous Infusion of Single Dose
This is a randomized, double-blind, placebo-controlled, phase I clinical study to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of JS016 (anti-SARS-CoV-2 monoclonal antibody) injection in Chinese healthy subjects after intravenous infusion of single dose.Eligible patients will be injection JS016 (anti-SARS-CoV-2 monoclonal antibody)
- Being tested
- JS016 (anti-SARS-CoV-2 monoclonal antibody)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS016 (anti-SARS-CoV-2 monoclonal antibody)Combination product
JS016 (anti-SARS-CoV-2 monoclonal antibody)
| Study group | Role | What they receive |
|---|---|---|
| Test group | Experimental | Not described Receives: Combination Product: JS016 (anti-SARS-CoV-2 monoclonal antibody) |
| Control group | Experimental | Not described Receives: Combination Product: JS016 (anti-SARS-CoV-2 monoclonal antibody) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of adverse events with the investigational product
Any adverse event, serious adverse event (SAE) occurred during the clinical study, including clinical symptoms and abnormal vital signs, abnormal 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
Measured: 12 Weeks
Secondary outcomes (4)
Primary pharmacokinetic variables
Area under the curve from the time of dosing to the last measurable concentration time t (AUC0-last);
Measured: 12 Weeks
Primary pharmacokinetic variables
Maximum concentration (Cmax);
Measured: 12 Weeks
Primary pharmacokinetic variables
Mean residence time (MRT)
Measured: 12 Weeks
Primary pharmacokinetic variables
Terminal half life (t1/2);
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start5 Jun 2020
- Primary completion11 Dec 2020 (estimated)
- Study completion11 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19; and High Infection Risk of SARS-CoV-2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04441918
- Sponsor's protocol ID
- JS016-001-I
- Status last verified
- Jun 2020
- First submitted
- 6 Jun 2020
- Last updated
- 22 Jun 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34473343Wu X, Li N, Wang G, Liu W, Yu J, Cao G, Wang J, Chen Y, Ma J, Wu J, Yang H, Mao X, He J, Yu Y, Qiu C, Li N, Yao S, Feng H, Yan J, Zhang W, Zhang J. Tolerability, Safety, Pharmacokinetics, and Immunogenicity of a Novel SARS-CoV-2 Neutralizing Antibody, Etesevimab, in Chinese Healthy Adults: a Randomized, Double-Blind, Placebo-Controlled, First-in-Human Phase 1 Study. Antimicrob Agents Chemother. 2021 Jul 16;65(8):e0035021. doi: 10.1128/AAC.00350-21. Epub 2021 Jul 16.
PubMed 33972256
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Phase I Clinical Study to Evaluate the Tolerability, Safety, Pharmacokinetic Profile and Immunogenicity of JS016 (Anti-SARS-CoV-2 Monoclonal Antibody) Injection in Chinese Healthy Subjects After Intravenous Infusion of Single Dose
- ClinicalTrials.gov ID
- NCT04441918
- Acronym / sponsor ID
- JS016-001-I
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- 11 Dec 2020 (estimated)
- Study completion
- 11 Dec 2020 (estimated)
- First posted
- 22 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled, phase I clinical study to evaluate the tolerability, safety, pharmacokinetic profile and immunogenicity of JS016 (anti-SARS-CoV-2 monoclonal antibody) injection in Chinese healthy subjects after intravenous infusion of single dose.Eligible patients will be injection JS016 (anti-SARS-CoV-2 monoclonal antibody)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test group | Experimental | Combination Product: JS016 (anti-SARS-CoV-2 monoclonal antibody) |
| Control group | Experimental | Combination Product: JS016 (anti-SARS-CoV-2 monoclonal antibody) |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male and female subjects aged 18 to 45 years, inclusive;
- The body weight no less than 50 kg for male subjects and no less than 45 kg for female subjects. Body mass index (BMI) = weight (kg)/square of height (m2), ranging from 18-28 kg/m2 (including the critical value);
- Normal or abnormal but clinically insignificant physical examination, vital signs, laboratory tests and other accessory examinations (chest radiology, abdominal B-mode ultrasonography, ECG, etc.);
- No plan of pregnancy and being willing to use effective contraceptive measures for subject (including partner) from informed consent to 6 months after administration of investigational product, see Appendix 5 for the specific contraceptive measures;
- The subjects are able to understand the content of the study and voluntary to sign the informed consent form; meanwhile, being able to complete the study as required in the protocol.
Key exclusion criteria (27 listed)
- Excluded for novel coronavirus (SARS-CoV-2) infection
- Having one of the following evidence on SARS-CoV-2 infection:
- Previous vaccination of SARS-CoV-2 vaccine or having participated in the clinical trial on SARS-CoV-2 neutralizing antibody;
- Use of therapeutic biologics within 12 weeks prior to screening, or remaining in the elimination period of the drug (within 5 half-lives) at random administration, whichever is longer;
- Participation in any other clinical study with intervention of investigational product within 4 weeks prior to screening, or remaining in the elimination period of the drug (within 5 half-lives) prior to screening, whichever is longer;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JS016 (anti-SARS-CoV-2 monoclonal antibody)JS016 (anti-SARS-CoV-2 monoclonal antibody) | Combination product | Control group, Test group |
Primary outcome
Correlation of adverse events with the investigational product
Time frame: 12 Weeks
Any adverse event, serious adverse event (SAE) occurred during the clinical study, including clinical symptoms and abnormal vital signs, abnormal 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
4 secondary outcomes
Primary pharmacokinetic variables
Time frame: 12 Weeks
Primary pharmacokinetic variables
Time frame: 12 Weeks
Primary pharmacokinetic variables
Time frame: 12 Weeks
Primary pharmacokinetic variables
Time frame: 12 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2020.
- Derived from this study: PubMed 34473343Kreuzberger 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.
- Derived from this study: PubMed 33972256Wu X, Li N, Wang G, Liu W, Yu J, Cao G, Wang J, Chen Y, Ma J, Wu J, Yang H, Mao X, He J, Yu Y, Qiu C, Li N, Yao S, Feng H, Yan J, Zhang W, Zhang J. Tolerability, Safety, Pharmacokinetics, and Immunogenicity of a Novel SARS-CoV-2 Neutralizing Antibody, Etesevimab, in Chinese Healthy Adults: a Randomized, Double-Blind, Placebo-Controlled, First-in-Human Phase 1 Study. Antimicrob Agents Chemother. 2021 Jul 16;65(8):e0035021. doi: 10.1128/AAC.00350-21. Epub 2021 Jul 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JS016 (anti-SARS-CoV-2 monoclonal antibody) in people with COVID-19; and High Infection Risk of SARS-CoV-2, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Zhang (021-52888189, 13816357098@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of adverse events with the investigational product (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04441918, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2020.