A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSS39 Injection in Healthy Chinese Subjects

NCT07057726 | Enrolling By Invitation Phase 1

• 1 other identifier: SYSS-SSS39-UND-I-01
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety, tolerability, and pharmacokinetics of SSS39 injection in healthy Chinese subjects

Conditions

Safety and Tolerability in Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• To evaluate the safety and tolerance of SSSS55

  Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  Day 50

Study Arms (2)

group 1

EXPERIMENTAL

Low-dose Group

Drug: SSS39

group 2

EXPERIMENTAL

high dose Group

Drug: SSS39

Interventions

SSS39 DRUG

Single oral administration of SSS39

group 1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Healthy subjects aged 18-45 years old (including boundary values), regardless of gender;
• \. Subjects voluntarily participate in clinical trials and sign informed consent;
• \. Male weight ≥50 kg, female weight ≥45 kg, body mass index (BMI) between 19-28 kg/m2 (including the cut-off value);

You may not qualify if:

• 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;
• Subjects who have received any other drug that acts on the mammalian target protein of rapamycin (mTOR);
• \. 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);
• 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;
• \. Acute or chronic systemic infection or local infection within 2 weeks before screening;
• \. 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;
• \. Those who have had major surgery or have not fully recovered from any previous invasive procedure within 4 weeks prior to dosing;
• \. 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);
• \. Past or present history of malignant tumors;
• \. 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);
• \. 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.;
• 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;
• 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;
• \. 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;
• 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;

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (1)

SSS39

Beijing, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2025
• First Posted: July 10, 2025
• Study Start: October 9, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)