Health VolunteerPhase 1NCT07101965

Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RSS0343 Tablets in Healthy Subjects After Single and Multiple Oral Administration and the Effect of Food on the Pharmacokinetics of RSS0343

A Phase 1 study of Health Volunteer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To evaluate the safety and tolerability of RSS0343 tablets in healthy subjects after single and multiple oral administration Read more about this study

Who is it for?: Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for: Health Volunteer
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 72 participants
Where: 1 siteChina
Study dates: 7 Apr 2024to 6 Nov 2024
Phase: Phase 1
Are there results?: None posted in the registry

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

Age of 18-55 years old (inclusive), male or female;
Body mass index in the range of 19-28 kg/m2 (inclusive).

Who cannot join

The results of physical examination, vital signs, laboratory tests, chest imaging, abdominal B ultrasound and 12-lead electrocardiogram were abnormal.
Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive;
Suspected allergy to the study drug or any component of the study drug, or severe allergy to any drug, food, toxin or other exposure;
Current active, latent, or inadequately treated M. tuberculosis (i.e., tuberculosis [TB]) infection;
Investigator-assessed clinically significant infection (e.g., requiring hospitalization or parenteral antimicrobial therapy) within 1 month before screening; A history of more than one previous episode of herpes zoster, or disseminated herpes zoster (one episode); Any history of other infections that the investigator considered might have been aggravated by study participation.

Trial locations and contacts

1 site in 1 country.

China1 site

The First Affiliated Hospital of Shandong First Medical University (Qianfoshan Hospital)
Shandong, Jinan, 250013

Other trials in China

About this study

To evaluate the safety and tolerability of RSS0343 tablets in healthy subjects after single and multiple oral administration

Conditions: Health Volunteer
Being tested: RSS0343 tablets ；placebo

What participants receive

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

RSS0343 tablets ；placeboDrug
RSS0343 tablets and placebo were given orally as a single dose
RSS0343 tablets ；placeboDrug
RSS0343 tablets and placebo were taken orally multiple times

Study groups in NCT07101965
Study group	Role	What they receive
Treatment group 1: RSS0343 tablets or placebo	Experimental	Not described Receives: Drug: RSS0343 tablets ；placebo
Treatment group 2: RSS0343 tablets or placebo	Experimental	Not described Receives: Drug: RSS0343 tablets ；placebo
Treatment group 3: RSS0343 tablets or placebo	Experimental	Not described Receives: Drug: RSS0343 tablets ；placebo
Treatment group 4: RSS0343 tablets or placebo	Experimental	Not described Receives: Drug: RSS0343 tablets ；placebo
Treatment group 5: RSS0343 tablets or placebo	Experimental	Not described Receives: Drug: RSS0343 tablets ；placebo
Treatment group 6: RSS0343 tablets or placebo	Experimental	Not described Receives: Drug: RSS0343 tablets ；placebo
Treatment group 7: RSS0343 tablets or placebo	Experimental	Not described Receives: Drug: RSS0343 tablets ；placebo
Treatment group 8: RSS0343 tablets or placebo	Experimental	Not described Receives: Drug: RSS0343 tablets ；placebo

What is being measured

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

adverse events
Measured: The observation lasted until the 61th day

Secondary outcomes (11)

Cmax
Measured: The observation lasted until the 33th day
AUC0-t
Measured: The observation lasted until the 33th day
AUC0-inf
Measured: The observation lasted until the 33th day
Tmax
Measured: The observation lasted until the 33th day
t1/2
Measured: The observation lasted until the 33th day
CL/F
Measured: The observation lasted until the 33th day
Vz/F
Measured: The observation lasted until the 33th day
Ae,urine
Measured: The observation lasted until the 33th day
fe,urine
Measured: The observation lasted until the 33th day
Relative bioavailability of premeal and postmeal administration
Measured: The observation lasted until the 16th day
Neutrophil elastase (NE) activity in peripheral blood after repeated oral administration of RSS0343
Measured: The observation lasted until the 61th day

Timeline

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

7 Apr 20246 Nov 2024

First posted3 Aug 2025
Study start7 Apr 2024
Primary completion6 Nov 2024
Study completion6 Nov 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Health VolunteerStudies 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: 72 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07101965
Sponsor's protocol ID: RSD51318
Status last verified: Jul 2025
First submitted: 13 Jul 2025
Last updated: 3 Aug 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 Health Volunteer trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Clinical Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RSS0343 Tablets in Healthy Subjects After Single and Multiple Oral Administration and the Effect of Food on the Pharmacokinetics of RSS0343
ClinicalTrials.gov ID: NCT07101965
Acronym / sponsor ID: RSD51318
Conditions: Health Volunteer
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 72 participants (actual)
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
Study start: 7 Apr 2024 (actual)
Primary completion: 6 Nov 2024 (actual)
Study completion: 6 Nov 2024 (actual)
First posted: 3 Aug 2025 (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.

To evaluate the safety and tolerability of RSS0343 tablets in healthy subjects after single and multiple oral administration

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 8

Arm	Type	Receives
Treatment group 1: RSS0343 tablets or placebo	Experimental	Drug: RSS0343 tablets ；placebo
Treatment group 2: RSS0343 tablets or placebo	Experimental	Drug: RSS0343 tablets ；placebo
Treatment group 3: RSS0343 tablets or placebo	Experimental	Drug: RSS0343 tablets ；placebo
Treatment group 4: RSS0343 tablets or placebo	Experimental	Drug: RSS0343 tablets ；placebo
Treatment group 5: RSS0343 tablets or placebo	Experimental	Drug: RSS0343 tablets ；placebo
Treatment group 6: RSS0343 tablets or placebo	Experimental	Drug: RSS0343 tablets ；placebo
Treatment group 7: RSS0343 tablets or placebo	Experimental	Drug: RSS0343 tablets ；placebo
Treatment group 8: RSS0343 tablets or placebo	Experimental	Drug: RSS0343 tablets ；placebo

Who may qualify

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

Key inclusion criteria (2 listed)

Age of 18-55 years old (inclusive), male or female;
Body mass index in the range of 19-28 kg/m2 (inclusive).

Key exclusion criteria (5 listed)

The results of physical examination, vital signs, laboratory tests, chest imaging, abdominal B ultrasound and 12-lead electrocardiogram were abnormal.
Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody, HIV antibody positive;
Suspected allergy to the study drug or any component of the study drug, or severe allergy to any drug, food, toxin or other exposure;
Current active, latent, or inadequately treated M. tuberculosis (i.e., tuberculosis [TB]) infection;
Investigator-assessed clinically significant infection (e.g., requiring hospitalization or parenteral antimicrobial therapy) within 1 month before screening; A history of more than one previous episode of herpes zoster, or disseminated herpes zoster (one episode); Any history of other infections that the investigator considered might have been aggravated by study participation.

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
RSS0343 tablets ；placeboRSS0343 tablets and placebo were given orally as a single dose	Drug	Treatment group 1: RSS0343 tablets or placebo, Treatment group 2: RSS0343 tablets or placebo, Treatment group 3: RSS0343 tablets or placebo, Treatment group 4: RSS0343 tablets or placebo, Treatment group 5: RSS0343 tablets or placebo
RSS0343 tablets ；placeboRSS0343 tablets and placebo were taken orally multiple times	Drug	Treatment group 6: RSS0343 tablets or placebo, Treatment group 7: RSS0343 tablets or placebo, Treatment group 8: RSS0343 tablets or placebo

Primary outcome

adverse events
Time frame: The observation lasted until the 61th day

11 secondary outcomes

Cmax
Time frame: The observation lasted until the 33th day
AUC0-t
Time frame: The observation lasted until the 33th day
AUC0-inf
Time frame: The observation lasted until the 33th day
Tmax
Time frame: The observation lasted until the 33th day
t1/2
Time frame: The observation lasted until the 33th day
CL/F
Time frame: The observation lasted until the 33th day
Vz/F
Time frame: The observation lasted until the 33th day
Ae,urine
Time frame: The observation lasted until the 33th day
fe,urine
Time frame: The observation lasted until the 33th day
Relative bioavailability of premeal and postmeal administration
Time frame: The observation lasted until the 16th day
Neutrophil elastase (NE) activity in peripheral blood after repeated oral administration of RSS0343
Time frame: The observation lasted until the 61th day

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Health Volunteer, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site 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 2 inclusion and 5 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: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

adverse events (time frame: The observation lasted until the 61th day). 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 NCT07101965.

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 3 Aug 2025.