Safety, Tolerance and Pharmacokinetics Clinical Study of VC005 in Healthy Subjects and Patients with Mild to Moderate Atopic Dermatitis

Korábbi kezelés

• Those who have received the vaccine within 2 weeks before administration or plan to receive the vaccine during the study period;
• Screening for individuals who have undergone any surgery within the previous 6 months;
• Those who participated in blood donation within the first 3 months of screening and had a blood donation volume of ≥ 400 mL, or received blood transfusion (excluding female physiological blood loss);
• Female subjects of childbearing age had unprotected sexual intercourse with their opposite sex partner within 14 days prior to screening;
• Screening of clinical trial participants (including excipient groups) who have participated in any drug or medical device within the first 3 months;
• Those who have received the vaccine within 2 weeks before administration or plan to receive the vaccine during the study period;
• Screening for individuals who have undergone any surgery within the previous 6 months;
• Those who participated in blood donation within the first 3 months of screening and had a blood donation volume of ≥ 400 mL, or received blood transfusion (excluding female physiological blood loss);
• Screening of clinical trial participants (including excipient groups) who have participated in any drug or medical device within the first 3 months;

Más betegség

• Suspected of being allergic to the study drug or any component of the study drug, or having an allergic constitution;
• Patients with difficulty in blood collection or inability to tolerate venous puncture, and those with a history of needle and blood fainting;
• Suspected of being allergic to the study drug or any component of the study drug, or having an allergic constitution;
• Patients with difficulty in blood collection or inability to tolerate venous puncture, and those with a history of needle and blood fainting;

Egyéb

• healthy subject's study:
• Pregnant and lactating women;
• Those who smoke ≥ 5 cigarettes per day within the first 3 months of screening, and cannot stop using any tobacco products from the end of screening to enrollment and during the trial period;
• Those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) within the first 3 months of screening, or who cannot abstain from alcohol during the trial period;
• Other situations where the researcher determines that it is not suitable to participate in the experiment.
  • patient's study:
• Pregnant and lactating women;
• Those who smoke ≥ 5 cigarettes per day within the first 3 months of screening, and cannot stop using any tobacco products from the end of screening to enrollment and during the trial period;
• Those who have consumed more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of 40% alcohol or 150 mL of wine) within the first 3 months of screening, or who cannot abstain from alcohol during the trial period;
• Other situations where the researcher determines that it is not suitable to participate in the experiment.

• healthy subject's study:
• Healthy male or female subjects, aged 18-45 years (including critical values);
• Body mass index (BMI) between 18 and 26kg/m2 (including critical values), with male weight ≥ 50kg and female weight ≥ 45kg;
• All women and men with fertility potential must be willing to use at least one efficient method of contraception from the signing of the informed consent form until 3 months after the last administration of the study drug, as detailed in Appendix 5;
• Voluntarily participate in the experiment and sign an informed consent form;
• Subjects who are able to communicate well with the researcher and are willing and able to comply with all planned visits, treatment plans, laboratory tests, and other research procedures
  • patient's study:
• When informed consent is given, the age range is between 18 and 75 years (including the boundary value), regardless of gender;
• Body mass index (BMI) between 18 and 26kg/m2 (including critical values), with male weight ≥ 50kg and female weight ≥ 45kg;
• Before administration, the diagnosis of mild to moderate atopic dermatitis should be met:
  • Overall Investigator Assessment (IGA) score of 2 to 3 points; Atopic dermatitis: total area of skin lesions 3% ≤ body surface area≤ 20%
• Voluntarily sign an informed consent form (with a date), indicating that the subject has been informed of all relevant parts of the study;
• All women and men with the possibility of childbirth must be willing to use at least one efficient method of contraception from the signing of the informed consent form until 3 months after the last administration of the study drug, as detailed in Appendix 5;
• Subjects who are willing and able to comply with planned visits and treatment plans, laboratory tests, and other research procedures