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 range18 Years – 55 Years

SexALL

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;
✕. Suspected allergy to the investigational drug product or any component of the investigational drug product
✕. Persons who have participated in clinical trials of any drug or medical device within 3 months prior to screening, or who are within 5 half-lives of the drug before screening (if the 5 half-lives exceed 3 months); Participants in clinical trials are defined as those who have given informed consent to clinical trials and have used investigational drugs (including placebo) or investigational medical devices;
✕. Those who had a history of smoking in the 3 months prior to screening or those who were positive in the screening period;
✕. Alcoholics within 3 months prior to screening or those who test positive for alcohol breath test during screening;
✕. Those who have a history of drug abuse, drug dependence or positive drug screening during the screening period;
✕. Pregnant or lactating women, pregnancy is defined as the female state from pregnancy to termination of pregnancy and the blood β-HCG test is positive during the screening period;

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 range18 Years – 55 Years

SexALL

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;
✕. Suspected allergy to the investigational drug product or any component of the investigational drug product
✕. Persons who have participated in clinical trials of any drug or medical device within 3 months prior to screening, or who are within 5 half-lives of the drug before screening (if the 5 half-lives exceed 3 months); Participants in clinical trials are defined as those who have given informed consent to clinical trials and have used investigational drugs (including placebo) or investigational medical devices;
✕. Those who had a history of smoking in the 3 months prior to screening or those who were positive in the screening period;
✕. Alcoholics within 3 months prior to screening or those who test positive for alcohol breath test during screening;
✕. Those who have a history of drug abuse, drug dependence or positive drug screening during the screening period;
✕. Pregnant or lactating women, pregnancy is defined as the female state from pregnancy to termination of pregnancy and the blood β-HCG test is positive during the screening period;

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