Phase
Condition
Atopic Dermatitis
Scalp Disorders
Allergies & Asthma
Treatment
VC005 Placebo
VC005
Clinical Study ID
Ages 18-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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 maleweight ≥ 50kg and female weight ≥ 45kg;
All women and men with fertility potential must be willing to use at least oneefficient method of contraception from the signing of the informed consent formuntil 3 months after the last administration of the study drug, as detailed inAppendix 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 andable to comply with all planned visits, treatment plans, laboratory tests, and otherresearch procedures
patient's study:
When informed consent is given, the age range is between 18 and 75 years (includingthe boundary value), regardless of gender;
Body mass index (BMI) between 18 and 26kg/m2 (including critical values), with maleweight ≥ 50kg and female weight ≥ 45kg;
Before administration, the diagnosis of mild to moderate atopic dermatitis should bemet: 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 subjecthas been informed of all relevant parts of the study;
All women and men with the possibility of childbirth must be willing to use at leastone efficient method of contraception from the signing of the informed consent formuntil 3 months after the last administration of the study drug, as detailed inAppendix 5;
Subjects who are willing and able to comply with planned visits and treatment plans,laboratory tests, and other research procedures
Exclusion
Exclusion Criteria:
healthy subject's study:
Suspected of being allergic to the study drug or any component of the study drug, orhaving an allergic constitution;
Those who have received the vaccine within 2 weeks before administration or plan toreceive the vaccine during the study period;
Screening for individuals who have undergone any surgery within the previous 6months;
Those who participated in blood donation within the first 3 months of screening andhad a blood donation volume of ≥ 400 mL, or received blood transfusion (excludingfemale physiological blood loss);
Female subjects of childbearing age had unprotected sexual intercourse with theiropposite sex partner within 14 days prior to screening;
Screening of clinical trial participants (including excipient groups) who haveparticipated in any drug or medical device within the first 3 months;
Pregnant and lactating women;
Patients with difficulty in blood collection or inability to tolerate venouspuncture, and those with a history of needle and blood fainting;
Those who smoke ≥ 5 cigarettes per day within the first 3 months of screening, andcannot stop using any tobacco products from the end of screening to enrollment andduring 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 monthsof screening, or who cannot abstain from alcohol during the trial period;
Other situations where the researcher determines that it is not suitable toparticipate in the experiment.
patient's study:
Suspected of being allergic to the study drug or any component of the study drug, orhaving an allergic constitution;
Those who have received the vaccine within 2 weeks before administration or plan toreceive the vaccine during the study period;
Screening for individuals who have undergone any surgery within the previous 6months;
Those who participated in blood donation within the first 3 months of screening andhad a blood donation volume of ≥ 400 mL, or received blood transfusion (excludingfemale physiological blood loss);
Screening of clinical trial participants (including excipient groups) who haveparticipated in any drug or medical device within the first 3 months;
Pregnant and lactating women;
Patients with difficulty in blood collection or inability to tolerate venouspuncture, and those with a history of needle and blood fainting;
Those who smoke ≥ 5 cigarettes per day within the first 3 months of screening, andcannot stop using any tobacco products from the end of screening to enrollment andduring 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 monthsof screening, or who cannot abstain from alcohol during the trial period;
Other situations where the researcher determines that it is not suitable toparticipate in the experiment.
Study Design
Connect with a study center
Chinese Academy of Medical Sciences Hospital of Skin Disease
Nanjing, Jiangsu
ChinaSite Not Available
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