What is STSA-1301 studying for Primary Immune Thrombocytopenia (ITP)?

STSA-1301 is being studied to evaluate its safety, how the body processes it, and its initial effects in patients with ITP and healthy volunteers. This trial aims to understand how multiple doses affect platelet levels and immune responses. The study is sponsored by Jiangsu BioJeTay Biotechnology Co., Ltd.

Who may be eligible for this Primary Immune Thrombocytopenia (ITP) clinical trial?

Adults aged 18 to 75 with a diagnosis of persistent or chronic primary ITP may be eligible. Participants must have tried and not fully responded to first-line ITP treatments and be willing to use contraception during the study. Please review eligibility criteria for more details.

Is there any cost to participate in this Primary Immune Thrombocytopenia (ITP) clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years - 75Years

All Genders

Healthy Volunteers

ID06929299

Phase IbII Study of Multiple Doses of STSA-1301 Injection in Healthy Adults and Adults With Immune Thrombocytopenia ITP to Assess Safety and Effects

Led by Jiangsu BioJeTay Biotechnology Co., Ltd. · Updated on 2026-08-12

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the safety, tolerability, and pharmacological effects of multiple doses of STSA-1301 subcutaneous injection in both healthy individuals and patients with Primary Immune Thrombocytopenia ITP. This randomized, double-blind, placebo-controlled trial also explores the initial effectiveness of STSA-1301 in patients with ITP. The study is sponsored by Jiangsu BioJeTay Biotechnology Co., Ltd. and aims to better understand how this treatment influences platelet counts and immune markers. Participants receive different doses of STSA-1301 or a placebo as subcutaneous injections according to the study protocol. The trial includes multiple dose levels low, median, and high doses, administered in separate cohorts. The study design is parallel and randomized, ensuring participants are assigned to one of the treatment groups or placebo without knowing their group. Treatments are given on specified dates, with monitoring for safety and immune responses over the course of the study. During the trial, participants undergo regular assessments including blood tests to measure platelet counts, immune markers such as serum IgG, cytokines, and anti-drug antibodies, as well as pharmacokinetic parameters like drug concentration in the blood. Researchers monitor any adverse events and changes in bleeding scores over a 78-day period following treatment. The study includes healthy volunteers and patients aged 18 to 75 years and lasts until September 2026. Participants will be closely observed throughout for treatment effects and safety.

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

Age: 18Years - 75Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

For stage I: Age between 18 and 50 years, male or female.
Body mass index between 18 and 26 kg/m².
Willingness to use effective contraception during the study period and for 3 months after the last dose.
Normal medical history and physical exam or abnormalities not clinically significant.
Voluntary participation with signed informed consent.
For stage 2: Age between 18 and 75 years.
Clinically diagnosed with persistent or chronic primary immune thrombocytopenia (ITP).
Prior response to ITP treatment with platelet count reaching at least 50×10⁹/L.
Average platelet count less than 30×10⁹/L with no single count above 35×10⁹/L during screening and baseline.
No severe bleeding within 4 weeks before screening.
Failed or intolerant to at least one first-line standard ITP treatment.
Stable dose of allowed concurrent ITP medications for at least 4 weeks prior to randomization.
Willingness to use effective contraception and no plans for pregnancy or sperm/egg donation during the study.
Ability to comply with study requirements and voluntary informed 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 before dosing.
History of immunodeficiency or malignant tumors.
Hypersensitivity to study product or ingredients.
Active tuberculosis or related lung changes.
Low total IgG or abnormal neutrophil or lymphocyte counts.
Positive tests for hepatitis B, hepatitis C, syphilis, or HIV.
Significant ECG abnormalities.
Issues interfering with blood collection.
Excessive caffeine or tobacco use before screening.
Regular alcohol use above limits or abnormal breath alcohol tests.
History of substance abuse within 1 year or positive urine screen.
Recent significant blood loss, transfusion, or participation in other trials.
Recent vaccinations or immune-modulating treatments.
Pregnant or breastfeeding women.
Investigator judgment deeming participation inappropriate.
For stage 2: Thrombocytopenia from other causes or abnormal lab tests.
Unstable or poorly controlled diseases other than ITP.
Recent use of anticoagulants, blood transfusions, or certain ITP treatments.
Prior 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.
Positive infectious disease markers.
Active tuberculosis or lung imaging changes.
Known hypersensitivity to study drug.
Recent participation in FcRn inhibitor studies or use of investigational drugs.
Pregnant, breastfeeding, or planning pregnancy during the study.
Autoimmune diseases other than ITP.
Other investigator-determined factors making participation inappropriate.

Research Team

Yanli Wang

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Phase IbII Study of Multiple Doses of STSA-1301 Injection in Healthy Adults and Adults With Immune Thrombocytopenia ITP to Assess Safety and Effects

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria