MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients… (NCT06361108) | Clinical Trial Compass
RecruitingPhase 1
MAD Study to Assess the Safety, Tolerability, PKs and Efficacy of YJ001 for Spray Use in Patients With DPNP
United States24 participantsStarted 2024-05-16
Plain-language summary
This Phase I, randomized, double-blind and placebo controlled study is to evaluate the safety, tolerability, and PK, and to preliminarily assess the efficacy of topically administered YJ001 in a multiple-ascending dose (MAD) fashion in the patients with DPNP. The study will be conducted at a single study center.
In this study, 2 cohorts (N=24, 12 subjects for each cohort), each cohort will consist of 10 active and 2 placebo, with approximately equal numbers of male and female subjects.
Each subject will be administered a single dose of YJ001 as multiple sprays topically on both feet and below the ankle in the morning on Day 1 and Day 2, and will be administered as twice daily doses once in the morning and the other in the evening (with an interval of 11 to 13 h) from Day 3 through Day 11.
Who can participate
Age range
18 Years – 80 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
. Intrauterine device (IUD) or IUD hormone-releasing system.
. Combined estrogen and progestogen containing hormonal contraception (oral, intravaginal, or transdermal) associated with inhibition of ovulation.
. Progesterone-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation.
. Intrauterine hormone-releasing system.
. Double-barrier method (condoms, contraceptive sponge, diaphragm, or vaginal ring with spermicide).
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.
What they're measuring
1
Safety Assessments - AEs
Timeframe: through study completion, an average of 1year
2
Safety Assessments -Number of Participants With Abnormal Laboratory Values
Timeframe: through study completion, an average of 1year
3
Safety Assessments - Skin Reaction
Timeframe: through study completion, an average of 1year