COVID-19Phase 1NCT05167279
A Study of JS026 and JS026 Together With JS016 for Treatment of COVID-19
A Phase 1 study of COVID-19, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 16 Dec 2021to 8 Dec 2022
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
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
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.
Read the 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.
- Conditions
- COVID-19
- Being tested
- JS026/placebo, JS016/placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS026/placeboBiological
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.
JS016/placeboBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| JS026/placebo 30 mg | Placebo comparator | 4 patients will be enrolled in this arm. Receives: Biological: JS026/placebo; Biological: JS016/placebo |
| JS026/placebo 100 mg | Placebo comparator | 4 patients will be enrolled in this arm. Receives: Biological: JS026/placebo; Biological: JS016/placebo |
| JS026/placebo 300 mg | Placebo comparator | 8 patients will be enrolled in this arm. Receives: Biological: JS026/placebo; Biological: JS016/placebo |
| JS026/placebo 600 mg | Placebo comparator | 8 patients will be enrolled in this arm. Receives: Biological: JS026/placebo; Biological: JS016/placebo |
| JS026/placebo 1000 mg | Placebo comparator | 8 patients will be enrolled in this arm. Receives: Biological: JS026/placebo; Biological: JS016/placebo |
| JS026/placebo 300 mg + JS016/placebo1200 mg | Placebo comparator | 8 patients will be enrolled in this arm. Receives: Biological: JS026/placebo; Biological: JS016/placebo |
| JS026/placebo 600 mg + JS016/placebo 1200 mg | Placebo comparator | 8 patients will be enrolled in this arm. Receives: Biological: JS026/placebo; Biological: JS016/placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 85 days
Secondary outcomes (7)
Pharmacokinetics: AUC
Area under the plasma concentration-time curve from the time of dosing to the last measurable concentration time t (AUC0-last)
Measured: Day 1 to D85
Pharmacokinetics: Tmax
Time to maximum concentration (Tmax)
Measured: Day 1 to D85
Pharmacokinetics: Cmax
Maximum concentration (Cmax)
Measured: Day 1 to D85
Pharmacokinetics: Vd
Apparent volume of distribution (Vd)
Measured: Day 1 to D85
Pharmacokinetics: CLt
Terminal clearance (CLt)
Measured: Day 1 to D85
Pharmacokinetics: t1/2
Elimination half-life (t1/2)
Measured: Day 1 to D85
Immunogenicity: ADA
Incidence of anti-drug antibodies (ADA)
Measured: Day 1 to D85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start16 Dec 2021
- Primary completion8 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
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
- NCT05167279
- Sponsor's protocol ID
- JS026-001-I
- Status last verified
- Jul 2023
- First submitted
- 13 Dec 2021
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05167279
- Acronym / sponsor ID
- JS026-001-I
- Conditions
- COVID-19
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 8 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 22 Dec 2021 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| JS026/placebo 30 mg | Placebo comparator | Biological: JS026/placebo, Biological: JS016/placebo4 patients will be enrolled in this arm. |
| JS026/placebo 100 mg | Placebo comparator | Biological: JS026/placebo, Biological: JS016/placebo4 patients will be enrolled in this arm. |
| JS026/placebo 300 mg | Placebo comparator | Biological: JS026/placebo, Biological: JS016/placebo8 patients will be enrolled in this arm. |
| JS026/placebo 600 mg | Placebo comparator | Biological: JS026/placebo, Biological: JS016/placebo8 patients will be enrolled in this arm. |
| JS026/placebo 1000 mg | Placebo comparator | Biological: JS026/placebo, Biological: JS016/placebo8 patients will be enrolled in this arm. |
| JS026/placebo 300 mg + JS016/placebo1200 mg | Placebo comparator | Biological: JS026/placebo, Biological: JS016/placebo8 patients will be enrolled in this arm. |
| JS026/placebo 600 mg + JS016/placebo 1200 mg | Placebo comparator | Biological: JS026/placebo, Biological: JS016/placebo8 patients will be enrolled in this arm. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| JS026/placeboFive 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. | Biological | JS026/placebo 100 mg, JS026/placebo 1000 mg, JS026/placebo 30 mg, JS026/placebo 300 mg, JS026/placebo 300 mg + JS016/placebo1200 mg, JS026/placebo 600 mg, JS026/placebo 600 mg + JS016/placebo 1200 mg |
| JS016/placeboTwo 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. | Biological | JS026/placebo 100 mg, JS026/placebo 1000 mg, JS026/placebo 30 mg, JS026/placebo 300 mg, JS026/placebo 300 mg + JS016/placebo1200 mg, JS026/placebo 600 mg, JS026/placebo 600 mg + JS016/placebo 1200 mg |
Primary outcome
Safety: Incidence and severity of any adverse events (AEs) occurring during the clinical trial per CTCAE V5.0
Time frame: 85 days
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.
7 secondary outcomes
Pharmacokinetics: AUC
Time frame: Day 1 to D85
Pharmacokinetics: Tmax
Time frame: Day 1 to D85
Pharmacokinetics: Cmax
Time frame: Day 1 to D85
Pharmacokinetics: Vd
Time frame: Day 1 to D85
Pharmacokinetics: CLt
Time frame: Day 1 to D85
Pharmacokinetics: t1/2
Time frame: Day 1 to D85
Immunogenicity: ADA
Time frame: Day 1 to D85
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 of COVID-19, 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 8 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: finished, as of the sponsor's last update on 1 Aug 2023. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence and severity of any adverse events (AEs) occurring during the clinical trial per CTCAE V5.0 (time frame: 85 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2023.