This study adopts a dose escalation design with six preset dose levels, namely 3mg, 30mg, 150mg, 300mg,600mg, 900mg, single subcutaneous injection. A total of 48 healthy subjects will be enrolled in the experiment, 8 in each group.They will be randomly assigned to receive JS010 injection and matching placebo in a ratio of 3:1. In accordance with the dose-escalation principle,Starting from the lowest initial dose, increasing to the higher dose and proceeding in sequence. Each subject can receive only one dose Level of single subcutaneous administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
48
This study adopts a dose escalation design with six preset dose levels, namely 3mg, 30mg, 150mg, 300mg,600mg, 900mg, single subcutaneous injection. A total of 48 healthy subjects were enrolled in the experiment, 8 in each group.They were randomly assigned to receive JS010 injection and matching placebo in a ratio of 3:1. In accordance with the dose-escalation principle,Starting from the lowest initial dose, increasing to the higher dose and proceeding in sequence. Each subject can receive only one dose Level of single subcutaneous administration.
This study adopts a dose escalation design with six preset dose levels, namely 3mg, 30mg, 150mg, 300mg,600mg, 900mg, single subcutaneous injection. A total of 48 healthy subjects were enrolled in the experiment, 8 in each group.They were randomly assigned to receive JS010 injection and matching placebo in a ratio of 3:1. In accordance with the dose-escalation principle,Starting from the lowest initial dose, increasing to the higher dose and proceeding in sequence. Each subject can receive only one dose Level of single subcutaneous administration.
Peking University Third Hospital
Beijing, Beijing Municipality, China
Incidence of Treatment-Emergent Adverse Events
Incidence and severity of adverse events (AE) and serious adverse events (SAE) , as well as abnormalities in vital signs, electrocardiogram and laboratory tests.
Time frame: up to 168 days post-dose
Peak Plasma Concentration (Cmax)
Peak Plasma Concentration of JS010
Time frame: up to 168 days post-dose
Time to Maximum Plasma Concentration (Tmax)
Time to Maximum Plasma Concentration of JS010
Time frame: up to 168 days post-dose
Terminal Elimination Half-Life (t1/2)
Terminal Elimination Half-Life (t1/2) of JS010
Time frame: up to 168 days post-dose
Area Under the Plasma Concentration Versus Time Curve (AUC)
Area Under the Plasma Concentration Versus Time Curve of JS010
Time frame: up to 168 days post-dose
Cutaneous blood flow
The rate of change in cutaneous blood flow at each time point was calculated and descriptive statistics were performed
Time frame: up to 168 days post-dose
Anti-drug antibodies (ADA)
JS010 Incidence and titer of anti-drug antibodies (ADA).
Time frame: up to 168 days post-dose
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