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| Name | Class |
|---|---|
| Sponsor GmbH | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental:JS002 AI | Experimental | The drug was administered by a single subcutaneous injection via AI |
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| Experimental:JS002 PFS | Active Comparator | The drug was administered by a single subcutaneous injection via PFS |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS002 | Drug | The drug was administered by a single subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-last | Area under the time-concentration curve from time 0 to last time of quantifiable concentration | 85 days |
| Cmax | Maximum Concentration | 85 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 85 days |
| Tmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shenzhen Third People's Hospital | Shenzhen | Guangdong | 518112 | China |
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None (Open Label)
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Time to reach maximum concentration |
| 85 days |
| t1/2 | Elimination half life | 85 days |
| CL/F | Apparent clearance | 85 days |
| Vz/F | Apparent volume of distribution | 85 days |
| AUECday1-85 | Area under the effect curve (AUEC) for LDL-C through Day 1 to day 85 | 85 days |
| PCSK9 | Serum concentration of PCSK9 | 85 days |
| Immunogenicity | Incidence of antidrug antibodies (ADA) | 85 days |
| Immunogenicity | Titer of ADA-positive samples, and incidence of neutralizing antibodies (Nab) | 85 days |