Health VolunteerPhase 1NCT05859529
A Pharmacokinetic Study of JS002 in Healthy Subjects
A Phase 1 study testing JS002 in people with Health Volunteer, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.
Trial summary
This study was a single-center, randomized, open-label, single-dose, parallel-controlled trial design conducted in healthy adult subjects. Subjects were randomly assigned to 1 of 2 parallel treatment groups: treatment group A received a single subcutaneous injection of JS002 150 mg via PFS, and treatment group B… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Health Volunteer
- What is being tested?
- JS002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 318 participants
- Where
- 1 siteChina
- Study dates
- 30 May 2023to 11 Sep 2023
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female volunteers aged 18-45 years at screening;
- have the ability to read and understand, voluntarily participate in the study, sign the written informed consent, and be able to complete the relevant procedures and examinations in accordance with the protocol;
- the body mass index (BMI) at screening ranged from 19 to 26 kg/m2 (inclusive), with body weight ≥50kg for men and ≥45kg for women;
- sitting blood pressure ≥ 90/60mmHg and < 140/90mmHg during screening;
- serum LDL-C level ≥1.8mmol/L and < 4.9mmol/L at screening;
- serum TG level < 2.8mmol/L at screening;
- infertile, or fertile women willing to use strict and effective contraceptive methods throughout the study, in addition, fertile female subjects should have negative blood pregnancy test results during the screening period.
Who cannot join
- Any history of use of Evolocumab and/or Alirocumab and other targeted drugs against PCSK9;
- Use of any therapeutic or investigational biologics within 6 months before baseline (day 1);
- Use of any medications or supplements that can alter blood lipids or affect lipid metabolism within 30 days before baseline (day 1), including but not limited to: Statins (such as atorvastatin, rosuvastatin, etc.), cholesterol absorption inhibitors (such as ezetimibe), probucol, cholic acid chelators (such as cholestyramine), traditional Chinese medicine (such as Xuezhikang), fibrates, high-purity fish oil preparations (or omega-3 fatty acids 1000 mg/ day), niacin preparations (niacin > 50 mg), etc.
- Initiation of new vigorous exercise (e.g., long-distance running) or dietary control, or major modification of previous diet or lifestyle (e.g., exercise, smoking, and alcohol consumption) within 30 days before baseline (day 1). Creatine kinase (CK) ≥3 times the upper limit of normal value (ULN) on the day before randomization (day-1);
- A history of allergy to biologics of mammalian origin (including monoclonal antibodies);
- Subjects with allergic diseases or allergic constitution;
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- Patients with definite diseases of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, endocrine system, and metabolic system that require medical intervention or other diseases that are not suitable for clinical trial (such as psychiatric history);
- Donating ≥400 mL within 3 months before screening, or donating ≥200 mL within 1 month before screening, or receiving blood transfusion;
- Participants who participated in other drug clinical trials within 3 months before screening;
- Those who had taken any prescription drugs, over-the-counter drugs, herbal medicines, or health supplements within 2 weeks before screening;
- Heavy smokers and drinkers (drinking 14 units of alcohol per week:1unit = beer 360 mL, or liquor 45 mL, or wine 150 mL; Smoking ≥5 cigarettes per day), or unable to abstain from smoking or drinking alcohol during the study period;
- Had a history of drug abuse, or used drugs within 3 months before screening, or had a positive urine drug screening test during the screening period;
- Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), treponema pallidum antibody and acquired immunodeficiency syndrome (HIV) antibody positive;
- Abnormal chest X-ray (posterior-anterior view) and abdominal B-ultrasound results with clinical significance (non-clinically significant conditions such as irritability of gallbladder wall, hepatic cysts, intrahepatic calcifications, intrahepatic bile duct stones, slight fatty liver, etc., should be excluded).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Open-label, Parallel-controlled Study Was Conducted to Compare the Pharmacokinetics of JS002 When Delivered Subcutaneously Via a Prefilled Syringe Versus a Prefilled Autosyringe in Healthy Subjects
This study was a single-center, randomized, open-label, single-dose, parallel-controlled trial design conducted in healthy adult subjects. Subjects were randomly assigned to 1 of 2 parallel treatment groups: treatment group A received a single subcutaneous injection of JS002 150 mg via PFS, and treatment group B received a single subcutaneous injection of JS002 150 mg via AI. Subjects were followed up to study day 85 for pharmacokinetic equivalence assessment of JS002. A total of 159 subjects were planned to be included in each group. After signing the informed consent form and completing the screening examination, subjects will be randomly assigned to treatment arm A or treatment arm B if eligible for inclusion.
The study period consisted of a screening period of up to 21 days and a follow-up period of 12 weeks (85 days). Subjects were admitted to the phase I clinical research unit the day before dose administration (day 1) and were not allowed to leave until all examinations and assessments were completed on day 6 after dose administration and were allowed to return to the clinical research center for follow-up visits on days 8,11,15,22,29,43,57,71, and 85.
- Conditions
- Health Volunteer
- Being tested
- JS002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS002Drug
The drug was administered by a single subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Experimental：JS002 AI | Experimental | The drug was administered by a single subcutaneous injection via AI Receives: Drug: JS002 |
| Experimental：JS002 PFS | Active comparator | The drug was administered by a single subcutaneous injection via PFS Receives: Drug: JS002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-last
Area under the time-concentration curve from time 0 to last time of quantifiable concentration
Measured: 85 days
Cmax
Maximum Concentration
Measured: 85 days
Secondary outcomes (9)
Incidence of Treatment-Emergent Adverse Events
Incidence and severity of adverse events (AE) and serious adverse events (SAE) as assessed according to NCI-CTCAE 5.0, as well as abnormalities in physical examination, vital signs, electrocardiogram, laboratory tests.
Measured: 85 days
Tmax
Time to reach maximum concentration
Measured: 85 days
t1/2
Elimination half life
Measured: 85 days
CL/F
Apparent clearance
Measured: 85 days
Vz/F
Apparent volume of distribution
Measured: 85 days
AUECday1-85
Area under the effect curve (AUEC) for LDL-C through Day 1 to day 85
Measured: 85 days
PCSK9
Serum concentration of PCSK9
Measured: 85 days
Immunogenicity
Incidence of antidrug antibodies (ADA)
Measured: 85 days
Immunogenicity
Titer of ADA-positive samples, and incidence of neutralizing antibodies (Nab)
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2023
- Study start30 May 2023
- Primary completion30 Jun 2023
- Study completion11 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health VolunteerStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Sponsor GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859529
- Sponsor's protocol ID
- JS002-008-BE
- Status last verified
- Sep 2024
- First submitted
- 23 Apr 2023
- Last updated
- 5 Sep 2024
- 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 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Open-label, Parallel-controlled Study Was Conducted to Compare the Pharmacokinetics of JS002 When Delivered Subcutaneously Via a Prefilled Syringe Versus a Prefilled Autosyringe in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05859529
- Acronym / sponsor ID
- JS002-008-BE
- Conditions
- Health Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- Shanghai Junshi Bioscience Co., Ltd.University, hospital or other
- Collaborators
- Sponsor GmbH
- Study start
- 30 May 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 11 Sep 2023 (actual)
- First posted
- 16 May 2023 (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 study was a single-center, randomized, open-label, single-dose, parallel-controlled trial design conducted in healthy adult subjects. Subjects were randomly assigned to 1 of 2 parallel treatment groups: treatment group A received a single subcutaneous injection of JS002 150 mg via PFS, and treatment group B received a single subcutaneous injection of JS002 150 mg via AI. Subjects were followed up to study day 85 for pharmacokinetic equivalence assessment of JS002. A total of 159 subjects were planned to be included in each group. After signing the informed consent form and completing the screening examination, subjects will be randomly assigned to treatment arm A or treatment arm B if eligible for inclusion.
The study period consisted of a screening period of up to 21 days and a follow-up period of 12 weeks (85 days). Subjects were admitted to the phase I clinical research unit the day before dose administration (day 1) and were not allowed to leave until all examinations and assessments were completed on day 6 after dose administration and were allowed to return to the clinical research center for follow-up visits on days 8,11,15,22,29,43,57,71, and 85.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental：JS002 AI | Experimental | Drug: JS002The drug was administered by a single subcutaneous injection via AI |
| Experimental：JS002 PFS | Active comparator | Drug: JS002The drug was administered by a single subcutaneous injection via PFS |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy male or female volunteers aged 18-45 years at screening;
- have the ability to read and understand, voluntarily participate in the study, sign the written informed consent, and be able to complete the relevant procedures and examinations in accordance with the protocol;
- the body mass index (BMI) at screening ranged from 19 to 26 kg/m2 (inclusive), with body weight ≥50kg for men and ≥45kg for women;
- sitting blood pressure ≥ 90/60mmHg and < 140/90mmHg during screening;
- serum LDL-C level ≥1.8mmol/L and < 4.9mmol/L at screening;
Key exclusion criteria (14 listed)
- Any history of use of Evolocumab and/or Alirocumab and other targeted drugs against PCSK9;
- Use of any therapeutic or investigational biologics within 6 months before baseline (day 1);
- Use of any medications or supplements that can alter blood lipids or affect lipid metabolism within 30 days before baseline (day 1), including but not limited to: Statins (such as atorvastatin, rosuvastatin, etc.), cholesterol absorption inhibitors (such as ezetimibe), probucol, cholic acid chelators (such as cholestyramine), traditional Chinese medicine (such as Xuezhikang), fibrates, high-purity fish oil preparations (or omega-3 fatty acids 1000 mg/ day), niacin preparations (niacin > 50 mg), etc.
- Initiation of new vigorous exercise (e.g., long-distance running) or dietary control, or major modification of previous diet or lifestyle (e.g., exercise, smoking, and alcohol consumption) within 30 days before baseline (day 1). Creatine kinase (CK) ≥3 times the upper limit of normal value (ULN) on the day before randomization (day-1);
- A history of allergy to biologics of mammalian origin (including monoclonal antibodies);
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 |
|---|---|---|
| JS002The drug was administered by a single subcutaneous injection | Drug | Experimental：JS002 AI, Experimental：JS002 PFS |
Primary outcome
AUC0-last
Time frame: 85 days
Area under the time-concentration curve from time 0 to last time of quantifiable concentration
Cmax
Time frame: 85 days
Maximum Concentration
9 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: 85 days
Tmax
Time frame: 85 days
t1/2
Time frame: 85 days
CL/F
Time frame: 85 days
Vz/F
Time frame: 85 days
AUECday1-85
Time frame: 85 days
PCSK9
Time frame: 85 days
Immunogenicity
Time frame: 85 days
Immunogenicity
Time frame: 85 days
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 5 Sep 2024.
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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 testing JS002 in people with Health Volunteer, 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 7 inclusion and 14 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 5 Sep 2024. 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?
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?
AUC0-last (time frame: 85 days). The study lists 2 primary outcomes in all. 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 5 Sep 2024.