Actively Recruiting
A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of STSA-1301 Subcutaneous Injection in Healthy Subjects and Patients With Immune Thrombocytopenia (ITP)
Led by Jiangsu BioJeTay Biotechnology Co., Ltd. · Updated on 2026-01-16
56
Participants Needed
7
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, pharmacokinetic and pharmacodynamic profiles, and immune response of multiple doses of STSA-1301 subcutaneous injection in healthy adults and patients with primary immune thrombocytopenia (ITP). This Phase Ib/II randomized, double-blind, placebo-controlled trial also aims to explore the initial effects of STSA-1301 on platelet counts in patients with ITP. The study is sponsored by Jiangsu BioJeTay Biotechnology Co., Ltd and includes participants aged 18 to 75 years. Participants receive varying doses of STSA-1301 or placebo through subcutaneous injections according to the study protocol. The trial includes three cohorts receiving low, median, or high doses of the study drug or placebo. Treatments are given multiple times over the study period, with careful monitoring of drug levels, immune response, and platelet counts to assess pharmacokinetics, pharmacodynamics, and potential benefits. During the 78-day study, participants undergo regular assessments including blood tests for platelet counts, immune markers, and drug concentration levels. Safety is closely monitored by tracking adverse events and immunogenicity. Additional measures include evaluating bleeding scores and cytokine levels. The trial requires informed consent and adherence to contraception requirements, with follow-up to assess outcomes and side effects throughout the study period.
CONDITIONS
Brief Title
A Phase Ib/II Clinical Trial of Multiple Doses of STSA-1301 Subcutaneous Injection in Healthy Subjects and Patients With Immune Thrombocytopenia (ITP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- For stage I: Age 18 to 50 years, male or female.
- Body mass index between 18 and 26 kg/m².
- Willingness to use effective contraception during the study and for 3 months after last dose, with no plans for pregnancy or sperm/egg donation.
- Normal medical history, physical exam, and lab tests or abnormalities not clinically significant.
- Voluntary participation with signed informed consent.
- For stage 2: Age 18 to 75 years, any gender.
- Clinically diagnosed with persistent or chronic primary immune thrombocytopenia (ITP) without other causes.
- Prior response to ITP treatment with platelet counts reaching at least 50×10⁹/L.
- Average platelet count below 30×10⁹/L during screening and baseline, with no count above 35×10⁹/L.
- No severe bleeding within 4 weeks before screening.
- Previously failed or intolerant to at least one first-line standard ITP treatment.
- Stable doses of certain ITP medications allowed if unchanged for 4 weeks before randomization.
- Agreement to use effective contraception during the study period.
- Ability to understand and comply with study protocol and provide consent.
You will not qualify if you...
- For stage I: History of serious medical conditions affecting drug metabolism.
- Active or serious infections within 6 weeks prior to dosing.
- History of immunodeficiency or malignant tumors.
- Hypersensitivity to product or ingredients; history of eczema, asthma, or allergies.
- Active tuberculosis or related lung abnormalities.
- Low immunoglobulin or certain blood cell counts below defined limits.
- Positive tests for hepatitis B, hepatitis C, syphilis, or HIV.
- Abnormal ECG or conditions interfering with blood collection.
- Excessive consumption of caffeine, tobacco, alcohol, or history of substance abuse.
- Recent significant blood loss, transfusion, or participation in other clinical trials.
- Recent vaccinations or treatments affecting immune function.
- Pregnant or breastfeeding women.
- Investigator judgment deeming participation inappropriate.
- For stage 2: Thrombocytopenia from other causes.
- Lab abnormalities including low IgG, high INR/APTT, or elevated liver enzymes.
- Unstable or uncontrolled diseases other than ITP.
- Recent use of anticoagulants, blood transfusions, immunoglobulins, or certain medications.
- Recent splenectomy or live/attenuated vaccinations.
- History of malignancy except cured carcinoma in situ.
- Recent thrombotic or embolic events.
- History or family history of coagulation disorders or hereditary thrombocytopenia.
- Significant bleeding requiring urgent treatment within 6 months.
- Active infections requiring systemic therapy.
- Positive hepatitis B, hepatitis C, HIV, or syphilis markers.
- Active tuberculosis or related lung imaging changes.
- Known hypersensitivity to study drug.
- Recent participation in other FcRn inhibitor studies or investigational drugs.
- Pregnant, breastfeeding, or planning pregnancy during the study.
- Autoimmune diseases other than ITP.
- Other conditions judged unsuitable for participation by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 11 weeks
Participants receive multiple doses of STSA-1301 subcutaneous injection or placebo as specified in the protocol to evaluate safety, tolerability, and pharmacodynamics.
Multiple dosing visits as per protocol
Duration - Up to 78 days from first dose
Participants are monitored for adverse events and treatment effects after the last dose.
Regular follow-up visits during monitoring period
Trial Site Locations
Total: 7 locations
1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233000
Actively Recruiting
2
Peking University People's Hospital
Beijing, Beijing Municipality, China, 101109
Actively Recruiting
3
North China University of Science and Technology Affiliated Hospital
Tangshan, Hebei, China, 063000
Actively Recruiting
4
Henan Cancer Hospital
Zhengzhou, Henan, China, 475000
Actively Recruiting
5
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China, 330000
Actively Recruiting
6
Xi'an Central Hospital
Xi’an, Shanxi, China, 710000
Actively Recruiting
7
Hospital of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
Research Team
Y
Yanli Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here