Dear Potential Subject,
West China Hospital of Sichuan University, The First Affiliated Hospital of Chongqing Medical University, Shanghai Fengxian District Central Hospital, and Hangzhou First People’s Hospital Affiliated to Westlake University School of Medicine are conducting a multicenter, randomized, double‑blind, dose‑parallel Phase I study in patients with superficial varicose veins of lower limbs in China. The study aims to evaluate the pharmacokinetic profile and safety of a single intravenous push injection of Sodium Tetradecyl Sulfate Injection. We are currently recruiting patients diagnosed with superficial varicose veins of lower limbs from the general public.
Investigational Drug
Sodium Tetradecyl Sulfate Injection is a sclerosant used for endovenous ablation in the treatment of lower limb varicose veins. When injected into the varicose vein lumen, it induces fibrotic closure, eliminating or alleviating local venous hypertension.
In this trial, the test product, Sodium Tetradecyl Sulfate Injection (STS), is manufactured by Shanghai SPH First Biochemical Pharmaceutical Co., Ltd. The reference product, Fibrovein® (marketed overseas), is manufactured by STD Pharmaceutical Products Limited and has not yet been introduced into China.
Risks and Benefits
The most common adverse reactions to Sodium Tetradecyl Sulfate Injection include urticaria with pain, superficial thrombophlebitis, and temporary skin pigmentation. Ulceration may occur after extravasation. The overall safety profile is acceptable.
This drug may supplement the current therapeutic options for sclerotherapy of lower limb varicose veins in China, providing more choices for patients. Your participation and the trial data you provide will help to better understand the pharmacokinetics and safety of Sodium Tetradecyl Sulfate Injection and contribute to the advancement of human health.
Basic Eligibility Criteria
1. Male or female subjects aged 18–65 years (inclusive);
2. CEAP grade C2–C4;
3. Female body weight ≥45.0 kg; male body weight ≥50.0 kg; BMI within 18.0–28.0 kg/m² (inclusive);
4. No participation in other drug/device clinical trials within 3 months prior to screening; no major surgery (requiring general anesthesia) or prolonged hospitalization within 12 weeks prior to screening;
5. No history of immediate hypersensitivity reactions or strong allergic predisposition;
6. No arterial disease, no high risk factors for thrombosis, and no history of related diseases;
7. Able to use effective contraception during the trial and have no plan for pregnancy (including partner) within 3 months after the trial; female subjects must not be pregnant within 12 weeks prior to screening and must not be lactating or pregnant;
8. Able to walk independently and to walk with necessary compression (wearing elastic stockings/bandages on lower limbs);
9. Willingly sign the informed consent form and, in the investigator’s judgment, be able to comply with all study requirements.
Subjects who pass screening and are enrolled will be insured and compensated for transportation, time loss, and other expenses incurred during compliance with all trial procedures. Professional research staff will explain the study details to you before screening.
If you meet the above criteria and are interested in participating, please contact us.
Contact Information
West China Hospital, Sichuan University
Address: No. 37, Guoxue Alley, Wuhou District, Chengdu
Contact: Assistant Hao
Phone: 13438006071
The First Affiliated Hospital of Chongqing Medical University
Address: No. 24, Shiyou Road, Yuzhong District, Chongqing
Contact: Assistant Chen
Phone: 13022303091
Shanghai Fengxian District Central Hospital
Address: No. 6600, Nanfeng Highway, Nanqiao New Town, Fengxian District, Shanghai
Contact: Assistant Zuo
Phone: 15318803344
Hangzhou First People’s Hospital Affiliated to Westlake University School of Medicine
Address: No. 261, Huansha Road, Hangzhou, Zhejiang
Contact: Dr. Chen
Phone: 18867158283
We will strictly protect your personal information in accordance with regulations. Your participation will contribute to medical scientific progress. We warmly welcome your enrollment.
