Actively Recruiting
A Phase Ib/II Clinical Trial 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
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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...
- Stage I: Age between 18 and 50 years, male or female
- Body mass index between 18 and 26 kg/m2
- Willing to use effective contraception during the study and for 3 months after last dose
- Normal medical history, physical exam, and lab tests or abnormalities not clinically significant
- Able to understand risks and voluntarily sign informed consent
- Stage II: Age between 18 and 75 years, any gender
- Clinically diagnosed with persistent or chronic primary immune thrombocytopenia (ITP) without other causes
- Prior response to ITP treatment with platelet count reaching ≥50×10^9/L
- Average platelet count <30×10^9/L during screening and baseline, with no single count >35×10^9/L
- No severe bleeding within 4 weeks before screening
- Previously failed or intolerant to at least one first-line standard ITP treatment
- Stable dose of allowed ITP medications for at least 4 weeks prior to randomization
- Willing to use effective contraception from informed consent until 3 months after last dose
- Able to comply with study protocol and voluntarily sign informed consent
You will not qualify if you...
- Stage I: History of serious medical conditions affecting drug processing
- Active or serious infection within 6 weeks prior to first dose or ongoing uncontrolled infections
- History of immunodeficiency or malignant tumors
- Hypersensitivity to study drug or ingredients; history of eczema, asthma, or allergies
- Active tuberculosis or related lung imaging changes or recent close contact with tuberculosis
- Low total IgG or low neutrophil or lymphocyte counts at screening
- Positive for hepatitis B, hepatitis C, syphilis, or HIV antibodies
- Significant abnormal electrocardiogram findings
- Conditions interfering with blood collection
- High consumption of coffee, tea, or cola (>5 cups/day) or smoking (>5 cigarettes/day) in 3 months prior
- Regular alcohol use exceeding limits or abnormal breath alcohol tests
- Substance abuse within 1 year or positive urine drug screen
- Recent significant blood loss, transfusion, or blood product use
- Participation in other clinical trials within 3 months
- Recent vaccinations within 4 weeks before screening up to 3 months after dosing
- Use of medications affecting immune function within specified timeframes
- Pregnant or breastfeeding women
- Investigator judgment of inappropriate participation
- Stage II: Thrombocytopenia due to other causes like lymphoma or viral infections
- Abnormal lab tests including low IgG, abnormal clotting times, or elevated liver enzymes
- Unstable or poorly controlled diseases other than ITP
- Recent use of anticoagulants, blood transfusions, immunoglobulins, or related therapies
- Recent splenectomy or vaccinations with live/attenuated vaccines
- History of malignancy except cured carcinoma in situ
- Recent thrombotic or embolic events
- History of coagulation disorders or hereditary thrombocytopenia
- Active significant bleeding requiring urgent treatment
- Active infections requiring systemic therapy within 4 weeks
- Positive for hepatitis B, hepatitis C, HIV, or syphilis antibodies
- Active tuberculosis or related lung changes
- Known hypersensitivity to study drug
- Prior participation in FcRn inhibitor studies within 6 months
- Recent use of investigational drugs
- Pregnant or breastfeeding or planning pregnancy during study
- Presence of other autoimmune diseases
- Investigator's judgment of inappropriate participation
AI-Screening
AI-Powered Screening
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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
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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