Safety, Tolerance and Pharmacokinetics Clinical Study of VC005 in Healthy Subjects and Patients w… (NCT06009094) | Clinical Trial Compass
CompletedPhase 1
Safety, Tolerance and Pharmacokinetics Clinical Study of VC005 in Healthy Subjects and Patients with Mild to Moderate Atopic Dermatitis
China80 participantsStarted 2023-07-27
Plain-language summary
This study is a single center, randomized, double-blind, Vehicle controlled,, single and multiple dose clinical study.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
. 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:
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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;