HealthyPhase 1NCT06308393

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

A Phase 1 study of Healthy and Psoriatic Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial summary

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

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, Psoriatic Subjects
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 98 participants
Where: 2 sitesChina
Study dates: 1 Mar 2024to Dec 2025
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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;

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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

Who cannot join

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;

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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
Currently has an active tuberculosis infection, or chest radiography indicates the presence of an active tuberculosis infection
Those who had undergone any surgery within 1 month prior to screening, or had not recovered as determined by the investigator, or had planned any surgery between the study period and 4 weeks after the study ended
The white blood cell count, neutrophil count, lymphocyte count, or hemoglobin in the blood routine examination during screening were out of the normal reference range and were deemed unsuitable for participation in this study by the investigators
Screening hepatitis B surface antigen, hepatitis C antibody, HIV antibody test any of the positive results;
Individuals who have participated in clinical trials of any drug or medical device within 3 months prior to signing the informed consent or within 5 half-lives of the investigational drug (whichever is older) (except those who have participated in other clinical trials but failed to be screened and administered)
The subject has any other condition that the investigator or sponsor considers unsuitable for study participation

Trial locations and contacts

2 sites in 1 country.

China2 sites

The First Affiliated Hospital of University of Science and Technology of China (USTC).
Hefei, Anhui, 200040
Huashan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 230000

Other trials in China

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Pharmacokinetic Profile of RSS0393 Ointment as a Single and Multiple Dose Ascending Local Dermal Administration in Healthy and Adult Subjects With Psoriasis

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

Conditions: Healthy, Psoriatic Subjects
Being tested: RSS0393 ointment；Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RSS0393 ointment；PlaceboDrug
RSS0393 ointment；RSS0393 ointment placebo

Study groups in NCT06308393
Study group	Role	What they receive
Treatment group 1	Experimental	Single dose in healthy subjects Receives: Drug: RSS0393 ointment；Placebo
Treatment group 2	Experimental	Multiple dose in healthy subjects Receives: Drug: RSS0393 ointment；Placebo
Treatment group 3	Experimental	Multiple dose in patients Receives: Drug: RSS0393 ointment；Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The percent of Local skin tolerance was assessed as moderate or higher（Single dose in healthy subjects）
Measured: 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）
Measured: 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 ）
Measured: Day 1, day 28, day 42 post-dose
Measurement of urine examination（Multiple dose in patients ）
Measured: Day 1, day 28, day 42 post-dose
Measurement of Blood Chemistry examination（Multiple dose in patients ）
Measured: Day 1, day 28, day 42 post-dose
Measurement of coagulation function examination（Multiple dose in patients ）
Measured: Day 1, day 28, day 42 post-dose

Secondary outcomes (23)

AUC0-t （Single dose in healthy subjects）
Measured: pre-dose,1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
AUC0-∞（Single dose in healthy subjects）
Measured: pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
Tmax（Single dose in healthy subjects）
Measured: pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
Cmax（Single dose in healthy subjects）
Measured: pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
t1/2（Single dose in healthy subjects）
Measured: pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
CL/F（Single dose in healthy subjects）
Measured: pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
Vz/F（Single dose in healthy subjects）
Measured: pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
AUC0-t （Multiple dose in healthy subjects）
Measured: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
AUC0-∞（Multiple dose in healthy subjects）
Measured: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
Tmax（Multiple dose in healthy subjects）
Measured: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
Cmax（Multiple dose in healthy subjects）
Measured: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
t1/2（Multiple dose in healthy subjects）
Measured: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
CL/F（Multiple dose in healthy subjects）
Measured: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
Vz/F（Multiple dose in healthy subjects）
Measured: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
Absolute change in PASI score relative to baseline（Multiple dose in patients ）
Measured: Day 7, Day 14, Day 28 post-dose
The percentage change in PASI score relative to baseline（（Multiple dose in patients ）
Measured: Day 7, Day 14, Day 28 post-dose
The percentage of PASI50、PASI75、PASI90、PASI100（Multiple dose in patients ）
Measured: Day 7, Day 14, Day 28 post-dose
The percentage of subjects' achieving PGA score of 0 or 1 and which improvement ≥ 2 from baseline （Multiple dose in patients ）
Measured: Day 7, Day 14, Day 28 post-dose
The percentage of subjects' inPGA score improvement ≥ 2 from baseline（Multiple dose in patients ）
Measured: Day 7, Day 14, Day 28 post-dose
Absolute change in BSA score relative to baseline（Multiple dose in patients ）
Measured: Day 7, Day 14, Day 28 post-dose
The percentage change in BSA score relative to baseline（Multiple dose in patients ）
Measured: Day 7, Day 14, Day 28 post-dose
Pharmacokinetics (PK) : Concentrations of RSS0393（Multiple dose in patients ）
Measured: Day1 ,Day 7, day 14, Day 28
Pharmacokinetics (PK) : The major metabolites of RSS0393（Multiple dose in patients ）
Measured: Day1 ,Day 7, day 14, Day 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 2024Dec 2025

First posted13 Mar 2024
Study start1 Mar 2024
Primary completionDec 2025 (estimated)
Study completionDec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 98 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06308393
Sponsor's protocol ID: RSP61418
Status last verified: Apr 2025
First submitted: 5 Feb 2024
Last updated: 2 May 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Healthy trials

Study at a glance

From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Pharmacokinetic Profile of RSS0393 Ointment as a Single and Multiple Dose Ascending Local Dermal Administration in Healthy and Adult Subjects With Psoriasis
ClinicalTrials.gov ID: NCT06308393
Acronym / sponsor ID: RSP61418
Conditions: Healthy, Psoriatic Subjects
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 98 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 1 Mar 2024 (actual)
Primary completion: Dec 2025 (estimated)
Study completion: Dec 2025 (estimated)
First posted: 13 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Treatment group 1	Experimental	Drug: RSS0393 ointment；PlaceboSingle dose in healthy subjects
Treatment group 2	Experimental	Drug: RSS0393 ointment；PlaceboMultiple dose in healthy subjects
Treatment group 3	Experimental	Drug: RSS0393 ointment；PlaceboMultiple dose in patients

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (9 listed)

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 ：

Key exclusion criteria (21 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RSS0393 ointment；PlaceboRSS0393 ointment；RSS0393 ointment placebo	Drug	Treatment group 1, Treatment group 2, Treatment group 3

Primary outcome

The percent of Local skin tolerance was assessed as moderate or higher（Single dose in healthy subjects）
Time frame: 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）
Time frame: 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 ）
Time frame: Day 1, day 28, day 42 post-dose
Measurement of urine examination（Multiple dose in patients ）
Time frame: Day 1, day 28, day 42 post-dose
Measurement of Blood Chemistry examination（Multiple dose in patients ）
Time frame: Day 1, day 28, day 42 post-dose
Measurement of coagulation function examination（Multiple dose in patients ）
Time frame: Day 1, day 28, day 42 post-dose

23 secondary outcomes

AUC0-t （Single dose in healthy subjects）
Time frame: pre-dose,1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
AUC0-∞（Single dose in healthy subjects）
Time frame: pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
Tmax（Single dose in healthy subjects）
Time frame: pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
Cmax（Single dose in healthy subjects）
Time frame: pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
t1/2（Single dose in healthy subjects）
Time frame: pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
CL/F（Single dose in healthy subjects）
Time frame: pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
Vz/F（Single dose in healthy subjects）
Time frame: pre-dose, 1, 2 , 4, 8, 12 , 24, 48, 96, 168 post-dose
AUC0-t （Multiple dose in healthy subjects）
Time frame: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
AUC0-∞（Multiple dose in healthy subjects）
Time frame: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
Tmax（Multiple dose in healthy subjects）
Time frame: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
Cmax（Multiple dose in healthy subjects）
Time frame: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
t1/2（Multiple dose in healthy subjects）
Time frame: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
CL/F（Multiple dose in healthy subjects）
Time frame: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
Vz/F（Multiple dose in healthy subjects）
Time frame: pre-dose, 1 ,2 , 4 , 8 , 12 , 24 post-dose Day1; pre-dose Day5 ; pre-dose Day6; pre-dose Day7; 1 , 2 , 4 , 8 , 12 , 24 , 48 , 96 , 168 post-dose Day7
Absolute change in PASI score relative to baseline（Multiple dose in patients ）
Time frame: Day 7, Day 14, Day 28 post-dose
The percentage change in PASI score relative to baseline（（Multiple dose in patients ）
Time frame: Day 7, Day 14, Day 28 post-dose
The percentage of PASI50、PASI75、PASI90、PASI100（Multiple dose in patients ）
Time frame: Day 7, Day 14, Day 28 post-dose
The percentage of subjects' achieving PGA score of 0 or 1 and which improvement ≥ 2 from baseline （Multiple dose in patients ）
Time frame: Day 7, Day 14, Day 28 post-dose
The percentage of subjects' inPGA score improvement ≥ 2 from baseline（Multiple dose in patients ）
Time frame: Day 7, Day 14, Day 28 post-dose
Absolute change in BSA score relative to baseline（Multiple dose in patients ）
Time frame: Day 7, Day 14, Day 28 post-dose
The percentage change in BSA score relative to baseline（Multiple dose in patients ）
Time frame: Day 7, Day 14, Day 28 post-dose
Pharmacokinetics (PK) : Concentrations of RSS0393（Multiple dose in patients ）
Time frame: Day1 ,Day 7, day 14, Day 28
Pharmacokinetics (PK) : The major metabolites of RSS0393（Multiple dose in patients ）
Time frame: Day1 ,Day 7, day 14, Day 28

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Healthy and Psoriatic Subjects, run by Jiangsu HengRui Medicine Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percent of Local skin tolerance was assessed as moderate or higher（Single dose in healthy subjects） (time frame: 0.5, 2, 4, 12 post -dose day 1, day 2, day 3, day 5, and day 8). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06308393.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2025.