A Phase I Clinical Trial to Evaluate CU-10101 Unguent (NCT06744569) | Clinical Trial Compass
By InvitationPhase 1
A Phase I Clinical Trial to Evaluate CU-10101 Unguent
China64 participantsStarted 2024-09-12
Plain-language summary
The study was conducted in two parts:Part 1 and Part 2.Part 1 is a single-site,randomized,double-blind,vehicle-controlled single and multiple administration,dose-escalation study in healthy Chinese participants.There are four cohorts in Part 1.Part 2 is a randomized,double-blind,vehicle-controlled single and multiple administration,dose-escalation study in Chinese participants with mild to moderate atopic dermatitis.It is planned to be conduct in 1 to 3 sites,with a total of four cohorts in Part 2.
Who can participate
Age range
18 Years – 65 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
.Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg; body mass index in the range of 18.0-27.0 kg/m2 (including cut-off);
.Based on physical examination, vital signs, electrocardiogram, and laboratory results, it was shown to be in good health without clinically significant abnormalities (as judged by the investigator);
.Ability to fully understand the contents of the study, voluntarily participate in the study, and sign the informed consent form. Follow protocol procedures to complete relevant visits during the study;
.Female participants of childbearing potential and male participants with partners of childbearing potential must consent from signing the informed consent form and no childbearing plan and voluntary use of appropriate contraception up to 3 months after the last dose.
.Diagnosed with AD according to Hanifin-Rajka diagnostic criteria and a history of AD assessed by the investigator for ≥ 6 months;
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.
.Male weight ≥ 50.0 kg, female weight ≥ 45.0 kg; body mass index in the range of 18.0-27.0 kg/m2 (including cut-off);
.Investigator Global Assessment (IGA) score of 2 or 3 at screening and baseline;
.At screening and baseline, BSA was 5% -40% (excluding the area of lesions on the scalp, face, genitalia and intertriginous sites \[e.g., axillary, inguinal, elbow fossa, etc.\] when calculating the lesion area);
Exclusion criteria
.Those who cannot tolerate venipuncture, or have a history of needle sickness and blood sickness;
.Subjects with skin damage, atopic dermatitis, eczema, rash, pigmentation and tattoos at the administration site, or other conditions judged by the investigator to be likely to affect drug absorption or affect skin tolerance;
.Previous or current significant or clinically significant diseases/abnormalities, including, but not limited to, heart/cardiocerebrovascular, respiratory, endocrine, gastrointestinal, kidney, liver, gallbladder, dermatological, hematological, immune, neurological or psychiatric diseases/abnormalities, or, as judged by the investigator, there is a safety risk or impact on safety, tolerability or pharmacokinetic assessment;
.Participants with a prior diagnosis of malignancy;
.Lactating women or women with positive pregnancy results, or women who plan to become pregnant during the study;
.Hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), treponema pallidum (TP) antibody, human immunodeficiency virus (HIV) antibody were positive;
.Those who smoke more than 5 cigarettes per day for 3 months prior to screening or cannot stop using any tobacco products during the study;
.Frequent drinkers within 3 months prior to screening, i.e., more than 14 units of alcohol per week (1 unit = 360 mL beer or 45 mL of spirits with 40% alcohol or 150 mL of wine) or who were unable to discontinue use of any alcoholic product during the study or had a positive alcohol breath test at screening;