Safety, Tolerability, Pharmacokinetics, Immunogenicity and Efficacy of STP705 in Adult Patients W… (NCT05196373) | Clinical Trial Compass
WithdrawnPhase 1/2
Safety, Tolerability, Pharmacokinetics, Immunogenicity and Efficacy of STP705 in Adult Patients With Hypertrophic Scars
Stopped: Study was cancelled.
China0Started 2021-12-07
Plain-language summary
Adult patients with hypertrophic scars 30 Subjects in Dose Escalation 20 Subjects in Dose Expansion Intrascar injection of STP705 weekly for 4 weeks
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female adult ≥ 18 and ≤ 45 years old at the time of signing the ICF,
. Diagnosed with hypertrophic scars, with all the following characteristics:
. Linear hypertrophic scar, with a width of 0.3-1.0 cm and a length of ≥10 cm;
. Scars with any of the following characteristics: redness or purpleness, stiffness, rough surface, significant swelling, visible dilated capillaries on the surface, and possibly accompanied by pain or itching;
. The course of the disease is 6 to 24 months (inclusive);
. Scars are not located on the face, front of the neck, feet, hands, knees, elbows or any joints;
. The examination during the screening period must meet the following criteria: medical history, physical examination (excluding hypertrophic scar), 12-lead ECG, vital signs, laboratory examinations are judged by the investigator to meet the requirements, and no clinically significant abnormalities were observed;
. Subjects of childbearing potential (male or female) must take effective medical contraceptive measures during the study and within 6 months after the end of administration;
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Concentration of siRNA-TGF-B1 and siRNA-COX-2 in serum
. Positive in hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV), or syphilis antibody tests;
. Medication history of corticosteroids use (including inhaled steroids, triamcinolone acetonide, etc.) and COX-2 inhibitors within 3 months before the first injection of the study (if 5 times the half-life is longer than 3 months, then 5 times the half-life will prevail);
. Impaired immune function (such as cancer, or other diseases that affect the basic immune responses);
. Concomitant diseases that is uncontrolled or poorly controlled or may affect the study, including clinically important cardiovascular, lung, kidney, endocrine, liver, nerve, mental, immune, gastrointestinal, blood, urogenital, skeletal or metabolic disorders at the investigator's discretion;
. Known to be allergic to STP705 or any components of its prescription;
. Having difficulty in venous blood collection, or having a history of needle fainting or blood fainting;