Safety and Tolerability in Healthy VolunteersPhase 1NCT07057726
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSS39 Injection in Healthy Chinese Subjects
A Phase 1 study testing SSS39 in people with Safety and Tolerability in Healthy Volunteers, run by Shenyang Sunshine Pharmaceutical Co., LTD. at 1 site in China.
Trial summary
To evaluate the safety, tolerability, and pharmacokinetics of SSS39 injection in healthy Chinese subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Safety and Tolerability in Healthy Volunteers
- What is being tested?
- SSS39
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2024to Oct 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Healthy subjects aged 18-45 years old (including boundary values), regardless of gender;
- 2. Subjects voluntarily participate in clinical trials and sign informed consent;
- 3. Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 19-28 kg/m2 (including the cut-off value);
Who cannot join
- 1.Have a clear history of drug or food allergy, or are known to have an allergic reaction to Sirolimus, polyethylene glycol and any excipients of this product, including lactose intolerance;
- 2.Subjects who have received any other drug that acts on the mammalian target protein of rapamycin (mTOR);
- 3. within 14 days prior to administration of the investigational product (or five half-lives of CYP3A4/P-gp inhibitors/inducers, whichever is longer), or anticipated use of a known major CYP3A4/P-gp inhibitor or major CYP3A4/P-gp inducer (including natural products) during the trial, Such as St. John's wort or grapefruit juice);
- 4.Abnormal results of sedimentation, abdominal B-ultrasonography, kidney B-ultrasonography or superficial lymph node B-ultrasonography during the screening period were judged by researchers to be clinically significant;
- 5. Acute or chronic systemic infection or local infection within 2 weeks before screening;
- 6. Previous or current history of autoimmune disease, immune deficiency, or history of organ transplantation, or/and use of immunomodulatory or immunosuppressive drugs within 6 months prior to screening;
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- 7. Those who have had major surgery or have not fully recovered from any previous invasive procedure within 4 weeks prior to dosing;
- 8. Have syphilis (positive for treponema pallidum antibodies) or AIDS (positive for HIV antibodies), or active hepatitis C (positive for hepatitis C virus antibodies and positive for hepatitis C virus [HCV]RNA results), or active hepatitis B (positive for hepatitis B surface antigen and hepatitis B virus [HBV] DNA above the lower limit of quantitative values);
- 9. Patients with past or present history of any clinically serious diseases, including but not limited to digestive system, cardiovascular system, respiratory system, urinary system, musculoskeletal system, endocrine system, neuropsychiatric system, blood system, etc. (except those considered by researchers to be eligible for inclusion);
- 10. Past or present history of malignant tumors;
- 11. Use of any drug (including prescription, over-the-counter, Chinese herbal, etc.) or supplement within 2 weeks prior to administration (if determined by the investigator, the time interval between the drug used and the beginning of administration of this trial \> 5 half-lives, corresponding subjects can also be enrolled);
- 12. Those who received live vaccines within 1 month before administration or planned to receive live vaccines during the study period, including but not limited to: measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG, typhoid vaccine, etc.;
- 13.Previous alcohol abuse or regular alcohol consumption in the 6 months prior to the test (drinking more than 14 units of alcohol per week, 1 unit =360 mL beer or 45 mL spirits with 40% alcohol or 150 mL wine) or a positive alcohol breath test (breath alcohol content \> 0.0 mg/100 mL), or those who cannot abstain from alcohol during the trial;
- 14.Those who test positive for one or more drug addiction and drug abuse tests, or have a history of drug abuse/dependence or drug abuse within the previous year;
- 15. habitual excessive consumption of tea, coffee or caffeinated beverages (more than 8 cups a day, 1 cup =200 mL), and/or ingestion of any food or beverage containing caffeine, alcohol, xanthine and other ingredients (such as coffee, strong tea, chocolate, etc.) within 48 hours before administration;
- 16.Smokers who smoked more than 5 cigarettes per day in the 3 months before screening and those who could not smoke during the whole test period;
- 17. Participants who have participated in any drug clinical trial and taken experimental drugs, or participated in device clinical trial and used experimental devices within 3 months before screening;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial Evaluating the Safety, Tolerability, and Pharmacokinetics of SSS39 Injection by Single Intravenous Infusion in Healthy Chinese Subjects
To evaluate the safety, tolerability, and pharmacokinetics of SSS39 injection in healthy Chinese subjects
Read the detailed description
This study was a single-administration, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK profile, immunogenicity, and effects on Treg cells and cytokines of SSS39 injection in healthy individuals.
- Being tested
- SSS39
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SSS39Drug
Single oral administration of SSS39
SSS39Drug
Single oral administration of SSS39
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | Low-dose Group Receives: Drug: SSS39 |
| group 2 | Experimental | high dose Group Receives: Drug: SSS39 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerance of SSSS55
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: Day 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start9 Oct 2024
- Primary completionOct 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Safety and Tolerability in Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Shenyang Sunshine Pharmaceutical 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07057726
- Sponsor's protocol ID
- SYSS-SSS39-UND-I-01
- Status last verified
- Jun 2025
- First submitted
- 6 Feb 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 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, Tolerability, and Pharmacokinetics of SSS39 Injection by Single Intravenous Infusion in Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT07057726
- Acronym / sponsor ID
- SYSS-SSS39-UND-I-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shenyang Sunshine Pharmaceutical Co., LTD.Industry (pharma, biotech, devices)
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- Oct 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 10 Jul 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, tolerability, and pharmacokinetics of SSS39 injection in healthy Chinese subjects
Detailed description
This study was a single-administration, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK profile, immunogenicity, and effects on Treg cells and cytokines of SSS39 injection in healthy individuals.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Drug: SSS39Low-dose Group |
| group 2 | Experimental | Drug: SSS39high dose Group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 1. Healthy subjects aged 18-45 years old (including boundary values), regardless of gender;
- 2. Subjects voluntarily participate in clinical trials and sign informed consent;
- 3. Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 19-28 kg/m2 (including the cut-off value);
Key exclusion criteria (17 listed)
- 1.Have a clear history of drug or food allergy, or are known to have an allergic reaction to Sirolimus, polyethylene glycol and any excipients of this product, including lactose intolerance;
- 2.Subjects who have received any other drug that acts on the mammalian target protein of rapamycin (mTOR);
- 3. within 14 days prior to administration of the investigational product (or five half-lives of CYP3A4/P-gp inhibitors/inducers, whichever is longer), or anticipated use of a known major CYP3A4/P-gp inhibitor or major CYP3A4/P-gp inducer (including natural products) during the trial, Such as St. John's wort or grapefruit juice);
- 4.Abnormal results of sedimentation, abdominal B-ultrasonography, kidney B-ultrasonography or superficial lymph node B-ultrasonography during the screening period were judged by researchers to be clinically significant;
- 5. Acute or chronic systemic infection or local infection within 2 weeks before screening;
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 |
|---|---|---|
| SSS39Single oral administration of SSS39 | Drug | group 1 |
| SSS39Single oral administration of SSS39 | Drug | group 2 |
Primary outcome
To evaluate the safety and tolerance of SSSS55
Time frame: Day 50
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
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 10 Jul 2025.
- Individual participant dataSharing planned: No
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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.
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 testing SSS39 in people with Safety and Tolerability in Healthy Volunteers, run by Shenyang Sunshine Pharmaceutical 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 3 inclusion and 17 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: enrolling by invitation, as of the sponsor's last update on 10 Jul 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?
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?
To evaluate the safety and tolerance of SSSS55 (time frame: Day 50). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2025.