A Clinical Trial Evaluated the Safety and Tolerability, Pharmacokinetic and Pharmacodynamics Profile, and Immunogenicity of a Single Dose of JS010 Injection in Healthy Subjects

Exclusion Criteria

• •Subjects' forearm skin could not be stimulated by capsaicin, or was unresponsive or abnormally responsive to capsaicin stimulation.
• •There is medical history or clinical evidence that the subject has a serious acute or chronic illness (including, but not limited to:
• •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.
• •There is obvious concomitant disease, or physical examination, laboratory examination, chest X-ray, abdominal B-ultrasound, and electrocardiogram which reveals any clinically significant abnormalities, discomfort or disease. According to the researchers, it is not in line with clinical practice.
• •There is a history of malignancy, except for carcinoma in situ that has been completely resected surgically.
• •Drug abuse or alcohol dependence within the last 1 year.
• •A known history of HIV and/or syphilis infection, or a positive test for HIV and/or syphilis antibodies at screening;
• •Known history of hepatitis B virus (HBV) and/or hepatitis C virus (HCV) infection, or hepatitis B surface at the time of screening
• •Antigen (HBsAg) and/or hepatitis C antibody positive.
• •Had undergone abdominal surgery or endoscopic intestinal surgery within 6 months prior to randomization.
• •Had undergone major surgical treatment within 6 months prior to randomization.
• •Had received hospitalization within 3 months prior to randomization.
• •Blood donation or blood loss ≥300ml in the 3 months prior to randomization.\[17\] Previously received drugs that target CGRP or CGRP receptors.
• •Use of any therapeutic or investigational biologics in the 6 months prior to randomization.
• •Participated in any of the trial drug interventions within 3 months or 5 half-lives (whichever is older) prior to randomization
• •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).
• •Received live vaccine within 30 days prior to randomization.
• •A history of allergy to biological agents, including monoclonal antibodies.
• •A history of severe allergies to food, drugs, insect bites, etc.
• •Pregnant and lactating women.
• •Any other situation in which the investigator deems it inappropriate to participate in the study, such as the subject having potential compliance problems; Unable to complete all inspections and evaluations as required by the programme