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| Name | Class |
|---|---|
| Sponsor GmbH | OTHER |
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This study is a single-center, randomized, open-label, single-dose, parallel-controlled trial design conducted in healthy adult subjects. After signing the informed consent form and completing the screening examination, if the subjects meet all the inclusion criteria and do not meet any exclusion criteria, they will be randomly assigned to treatment group A or treatment group B: treatment group A receives a single subcutaneous injection of JS005 300 mg through PFS, and treatment group B receives a single subcutaneous injection of JS005 300 mg through AI. Subjects were followed up until the 85th day of the study to evaluate the pharmacokinetic equivalence of JS005. 136 subjects are planned to be included in each group.
The entire study cycle includes a screening period of up to 21 days and a follow-up period of 12 weeks (85 days). Subjects will be admitted to the Phase I clinical research ward on the day before administration (D-1), and can only leave after completing all examinations and evaluations on the 11th day after administration. They will return to the clinical research center for follow-up on days 15, 22, 29, 43, 57, 71, and 85.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental:JS005 AI | Experimental | The drug was administered by a single subcutaneous injection via AI |
|
| Experimental:JS005 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 |
|---|---|---|---|---|
| JS005 | Drug | JS005: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 |
| AUC0-inf | Area under the time-concentration curve from time 0 to inf of quantifiable concentration | 85 days |
| Measure | Description | Time Frame |
|---|---|---|
| incidence and severity of adverse events(AE) | incidence and severity of adverse events(AE) | 85 days |
| The time to reach Cmax (Tmax) | Pharmacokinetic (PK) parameters of JS005 :The time to receive reach Cmax (Tmax) |
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Inclusion criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhengzhou Sixth People's Hospital | Zhengzhou | Henan | 450015 | China |
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None (Open Label)
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| 85 days |
| Apparent clearance(CL/F) | Apparent clearance(CL/F) of JS005 :apparent clearance(CL/F) | 85 days |
| T1/2 | Elimination half-life of JS005 | 85 days |
| Vz/F | Apparent volume of distribution of JS005 | 85 days |
| ADA | Incidence of anti-JS005 drug antibodies (ADA) | 85 days |
| ADA-positive | Titers of ADA-positive samples | 85 days |
| NAb | Incidence of neutralizing antibodies (NAb) | 85 days |