Active — Not RecruitingPhase 1

Randomized, Double-blind, Placebo-controlled Study of RSS0393 Ointment in Healthy and Psoriatic Subjects

China98 participantsStarted 2024-03-01

Plain-language summary

Randomized, double-blind, placebo-controlled study of RSS0393 ointment in healthy and psoriatic subjects

Who can participate

Age range

18 Years – 55 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

. Sign informed consent before the test, fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the requirements of the test plan
. The age of signing the informed consent must be ≥18 years old and ≤55 years old, male or female
. Male subjects weighed ≥50 kg, female subjects weighed ≥45 kg, and body mass index (BMI) was in the range of 19.0\~26.0 kg/m2
. The age of signing the informed consent must be ≥18 years old and ≤55 years old, male or female;
. Male subject ≥50 kg, female subject ≥45 kg, body mass index (BMI) in the range of 19.0\~26.0 kg/m2 (including boundary values)
. At the time of screening and baseline, the clinical diagnosis of psoriasis was at least 6 months
. During screening, the condition of the subjects was in a stable stage, requiring no new skin lesions, no continuous expansion of original skin lesions, and no obvious features of skin inflammation within 6 months before screening

Exclusion criteria

. The subject has skin conditions that may affect the evaluation of the administration site
. Patients with severe infection, severe trauma or major surgical operation within 3 months before screening; Patients who plan to undergo surgery during the trial period and within 2 weeks after the end of the trial;

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

The percent of Local skin tolerance was assessed as moderate or higher（Single dose in healthy subjects）

Timeframe: 0.5, 2, 4, 12 post -dose day 1, day 2, day 3, day 5, and day 8

The percent of Local skin tolerance was assessed as moderate or higher （Multiple dose in healthy subjects）

Timeframe: 0.5, 2, 4, 12 post-dose day 1, 0.5post-dose on day2、day3、day4、day5、day6, 0.5, 2, 4, 12 post-dose day7, day8, day9, day11, day14

Measurement of blood examination（Multiple dose in patients ）

Timeframe: Day 1, day 28, day 42 post-dose

Measurement of urine examination（Multiple dose in patients ）

Timeframe: Day 1, day 28, day 42 post-dose

Measurement of Blood Chemistry examination（Multiple dose in patients ）

Timeframe: Day 1, day 28, day 42 post-dose

Measurement of coagulation function examination（Multiple dose in patients ）

Timeframe: Day 1, day 28, day 42 post-dose

Trial details

NCT IDNCT06308393

SponsorJiangsu HengRui Medicine Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Healthy trials

Who can participate

Age range

18 Years – 55 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

. Sign informed consent before the test, fully understand the test content, process and possible adverse reactions, and be able to complete the study according to the requirements of the test plan
. The age of signing the informed consent must be ≥18 years old and ≤55 years old, male or female
. Male subjects weighed ≥50 kg, female subjects weighed ≥45 kg, and body mass index (BMI) was in the range of 19.0\~26.0 kg/m2
. The age of signing the informed consent must be ≥18 years old and ≤55 years old, male or female;
. Male subject ≥50 kg, female subject ≥45 kg, body mass index (BMI) in the range of 19.0\~26.0 kg/m2 (including boundary values)
. At the time of screening and baseline, the clinical diagnosis of psoriasis was at least 6 months
. During screening, the condition of the subjects was in a stable stage, requiring no new skin lesions, no continuous expansion of original skin lesions, and no obvious features of skin inflammation within 6 months before screening

Exclusion criteria

. The subject has skin conditions that may affect the evaluation of the administration site
. Patients with severe infection, severe trauma or major surgical operation within 3 months before screening; Patients who plan to undergo surgery during the trial period and within 2 weeks after the end of the trial;

What they're measuring

The percent of Local skin tolerance was assessed as moderate or higher（Single dose in healthy subjects）

Timeframe: 0.5, 2, 4, 12 post -dose day 1, day 2, day 3, day 5, and day 8

The percent of Local skin tolerance was assessed as moderate or higher （Multiple dose in healthy subjects）

Timeframe: 0.5, 2, 4, 12 post-dose day 1, 0.5post-dose on day2、day3、day4、day5、day6, 0.5, 2, 4, 12 post-dose day7, day8, day9, day11, day14

Measurement of blood examination（Multiple dose in patients ）

Timeframe: Day 1, day 28, day 42 post-dose

Measurement of urine examination（Multiple dose in patients ）

Timeframe: Day 1, day 28, day 42 post-dose

Measurement of Blood Chemistry examination（Multiple dose in patients ）

Timeframe: Day 1, day 28, day 42 post-dose

Measurement of coagulation function examination（Multiple dose in patients ）

Timeframe: Day 1, day 28, day 42 post-dose