Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: JS010 injection | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JS010 injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 168 days post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Peak Plasma Concentration (Cmax) | Peak Plasma Concentration of JS010 | up to 168 days post-dose |
| Time to Maximum Plasma Concentration (Tmax) | Time to Maximum Plasma Concentration of JS010 |
Not provided
Inclusion Criteria:
Blood pregnancy detection knot during ovular tubule resection or ligation, or menopause for more than 1 year), or screening of fertile persons' results were negative, and they were willing to use strict and effective contraceptive methods (such as medication or barrier methods) during the study period.
Male subjects were required to consent to a strict and effective form of contraception.
· Subjects are willing and able to complete the procedures and examinations associated with the trial, and can maintain a stable diet, exercise and ohter lifestyle habits during the trial.
Exclusion Criteria:
Heart, kidney, nerve, endocrine, blood, immune, infection, metabolic dysfunction, etc.), by investigator judged that participating in the study could confound the results or put the subjects at risk.
Antigen (HBsAg) and/or hepatitis C antibody positive.
The clinical study.
· Had used any prescription drugs or drugs within 30 days prior to randomization or 5 half-lives, whichever is older
Remedies, including Chinese herbs, vitamins and dietary supplements (hormones used in contraception for women of childbearing age)
Except for birth control pills).
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiyan Li, PhD | Contact | +86 10-68966677 | haiyanli1027@hotmail.com | |
| Fangfang Wang, PhD | Contact | +86 10-68966677 | doctorfancy@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Haiyan Li, PhD | Peking University Third Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Third Hospital | Recruiting | Beijing | Beijing Municipality | 100191 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo | Drug | 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. |
|
| up to 168 days post-dose |
| Terminal Elimination Half-Life (t1/2) | Terminal Elimination Half-Life (t1/2) of JS010 | 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 | 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 | up to 168 days post-dose |
| Anti-drug antibodies (ADA) | JS010 Incidence and titer of anti-drug antibodies (ADA). | up to 168 days post-dose |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided