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

Korábbi kezelés

• Drug abuse or alcohol dependence within the last 1 year.
• 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.

Más betegség

• 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 a history of malignancy, except for carcinoma in situ that has been completely resected surgically.
• 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.
• A history of allergy to biological agents, including monoclonal antibodies.
• A history of severe allergies to food, drugs, insect bites, etc.

Laborértékek

• 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.

Egyéb

• Subjects' forearm skin could not be stimulated by capsaicin, or was unresponsive or abnormally responsive to capsaicin stimulation.
• 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

• Subject understands and voluntarily signs a written informed consent form (ICF).
• Healthy male or female subjects aged 18-45 years (inclusive) at the time of signing informed consent.
• The body mass index (BMI) at screening was in the range of 18.5~28.0kg/m2 (inclusive).
• Female subjects must meet the following conditions: no fertility (e.g. documented hysterectomy, bilateral transfusion;
  • 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.