Status:
COMPLETED
Safety, Tolerance and Pharmacokinetics Clinical Study of VC005 in Healthy Subjects and Patients with Mild to Moderate Atopic Dermatitis
Lead Sponsor:
Jiangsu vcare pharmaceutical technology co., LTD
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study is a single center, randomized, double-blind, Vehicle controlled,, single and multiple dose clinical study.
Eligibility Criteria
Inclusion
- 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
Exclusion
- healthy subject's study:
- Suspected of being allergic to the study drug or any component of the study drug, or having an allergic constitution;
- 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;
- Pregnant and lactating women;
- Patients with difficulty in blood collection or inability to tolerate venous puncture, and those with a history of needle and blood fainting;
- 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:
- Suspected of being allergic to the study drug or any component of the study drug, or having an allergic constitution;
- 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;
- Pregnant and lactating women;
- Patients with difficulty in blood collection or inability to tolerate venous puncture, and those with a history of needle and blood fainting;
- 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.
Key Trial Info
Start Date :
July 27 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2024
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06009094
Start Date
July 27 2023
End Date
May 23 2024
Last Update
December 10 2024
Active Locations (1)
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1
Chinese Academy of Medical Sciences Hospital of Skin Disease
Nanjing, Jiangsu, China