A Phase Ib/II Clinical Trial of Multiple Doses of STSA-1301 Subcutaneous Injection in Healthy Sub… (NCT06929299) | Clinical Trial Compass
RecruitingPhase 1/2
A Phase Ib/II Clinical Trial of Multiple Doses of STSA-1301 Subcutaneous Injection in Healthy Subjects and Patients With Immune Thrombocytopenia (ITP)
China56 participantsStarted 2025-05-12
Plain-language summary
A randomized, double-blind, placebo-controlled design was designed to evaluate the safety and tolerability, pharmacokinetic/pharmacodynamic profile, and immunogenicity of multiple administration of STSA-1301 subcutaneous injection in healthy subjects and patients with ITP, and to further explore the initial efficacy of STSA-1301 subcutaneous injection in patients with ITP
Who can participate
Age range
18 Years – 75 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
. 18 years ≤ age ≤ 50 years, male or female subjects;
. Body mass index is 18 kg/m\^2≤ BMI≤ 26kg/m\^2;
. Subjects (including the subject's partner) are willing to use effective contraception during the study period and have no plans to have children or to donate sperm or eggs from the time of signing the informed consent form until 3 months after the last dose;
. Pre-randomization medical history had no effect on enrollment in the trial, and physical examination, laboratory test items, and all tests related to the trial were normal or the investigator determined that the abnormalities were not clinically significant;
. Subjects are aware of the risks of the trial and voluntarily participate in this clinical trial and sign an informed consent form.
. Aged 18 to 75 years, inclusive, and of either gender.
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
To Evaluate any adverse event that occurs in the subject after administration of the drug
. Clinically diagnosed with persistent or chronic primary immune thrombocytopenia (ITP) with no known other causes of thrombocytopenia.
. The ITP diagnosis of the subject is supported by a prior response to ITP treatment with a platelet count reaching ≥50×10\^9/L.
Exclusion criteria
. Subject has a history of serious medical conditions (including, but not limited to, gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, pulmonary, immunologic, psychiatric, or cardiovascular disorders) or any disease or sequela known to be likely to interfere with the absorption, distribution, metabolism, or excretion of the test drug;
. Subjects with an active infection or with a serious infection (resulting in hospitalization or requiring parenteral antibiotic therapy) within 6 weeks prior to the first dose; subjects with a combination of clinically significant active or chronic uncontrolled bacterial, viral, or fungal infections at screening;
. Subjects have a history of immunodeficiency;
. Subjects had a history of malignant tumors;
. Subjects who are hypersensitive to the product or any of its ingredients; history of eczema, asthma or other allergic diseases;
. Current active tuberculosis, including pulmonary and extrapulmonary tuberculosis; tuberculosis-related imaging changes in the lungs (e.g., cavities, infiltrative lesions) detected by chest X-ray; and a history of close contact with an active case of tuberculosis in the past 1 year.
. Subject's total IgG at Screening/Baseline is less than the lower limit of normal. Subject has an absolute neutrophil count \<1.5X10\^9/L and/or an absolute lymphocyte count \<1.0× 10\^9/L;
. Positive Hepatitis B Surface Antigen (HBsAg) or Hepatitis B Core Antibody (HBcAb), Hepatitis C Virus Antibody (Anti-HCV), Syphilis Specific Antibody, and Positive HIV Antibody (Anti-HIV);