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

NCT06308393 | Active Not Recruiting Phase 1

• 1 other identifier: RSP61418
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy; Psoriatic Subjects

Outcome Measures

Primary Outcomes (6)

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

  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）

  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 ）

  Day 1, day 28, day 42 post-dose

• Measurement of urine examination（Multiple dose in patients ）

  Day 1, day 28, day 42 post-dose

• Measurement of Blood Chemistry examination（Multiple dose in patients ）

  Day 1, day 28, day 42 post-dose

• Measurement of coagulation function examination（Multiple dose in patients ）

  Day 1, day 28, day 42 post-dose

Secondary Outcomes (23)

• AUC0-t （Single dose in healthy subjects）

  pre-dose,1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose

• AUC0-∞（Single dose in healthy subjects）

  pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose

• Tmax（Single dose in healthy subjects）

  pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose

• Cmax（Single dose in healthy subjects）

  pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose

• t1/2（Single dose in healthy subjects）

  pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose

Study Arms (3)

Treatment group 1

EXPERIMENTAL

Single dose in healthy subjects

Drug: RSS0393 ointment；Placebo

Treatment group 2

EXPERIMENTAL

Multiple dose in healthy subjects

Drug: RSS0393 ointment；Placebo

Treatment group 3

EXPERIMENTAL

Multiple dose in patients

Drug: RSS0393 ointment；Placebo

Interventions

RSS0393 ointment；Placebo DRUG

RSS0393 ointment；RSS0393 ointment placebo

Treatment group 1; Treatment group 2; Treatment group 3

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Healthy Volunteers：
• 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
• Patients ：
• 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

You may not qualify if:

• \- Healthy Volunteers：
• 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;
• Patients ：
• Subjects had skin conditions other than psoriasis that could affect the evaluation of the study drug administration site
• Suspected allergy to the investigational drug product or any component of the investigational drug product;
• Subjects had a history of any active malignancy or malignancy in the 5 years prior to the screening visit, except skin squamous cell carcinoma or basal cell carcinoma, or cervical cancer in situ, which had resolved after treatment
• Pre-existing or current clinically significant cardiovascular, liver, neurological, respiratory, blood, gastrointestinal, immune, and kidney diseases or a history of psychiatric disorders that may affect study results or affect drug absorption, distribution, metabolism, and excretion or place subjects at undue risk
• Participants who had a history of depression and/or were clinically deemed to be at risk of suicide during the screening period and at baseline were excluded

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (2)

The First Affiliated Hospital of University of Science and Technology of China (USTC).

Hefei, Anhui, 200040, China

Location

Huashan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 230000, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: March 13, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 2, 2025

Record last verified: 2025-04

Locations

CN (2)