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New treatment option for Primary Immune Thrombocytopenia (ITP)
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)
ClinicalTrials.gov ID: NCT06929299
What this study is testing
What is STSA-1301 subcutaneous injection?
STSA-1301 subcutaneous injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for primary immune thrombocytopenia (itp).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75. Healthy volunteers may be eligible.
You may be able to join if
- \- (stage I):
- 18 years ≤ age ≤ 50 years, male or female people;
- Body mass index is 18 kg/m\^2≤ BMI≤ 26kg/m\^2;
- people (including the subject's partner) are willing to use effective contraception during the study period and have no plans to have children or to...
- Pre-randomization medical history had no effect on enrollment in the trial, and physical examination, laboratory test items, and all tests related to...
You likely can't join if
- \- (stage I)
- Subject has a history of serious medical conditions (including, but not limited to, gastrointestinal, renal, hepatic, neurologic, hematologic...
- people with an active infection or with a serious infection (resulting in hospitalization or requiring parenteral antibiotic therapy) within 6 weeks...
- people have a history of immunodeficiency;
- people had a history of malignant tumors;
- people who are hypersensitive to the product or any of its ingredients; history of eczema, asthma or other allergic diseases;
See the full eligibility criteria
Who can join
- \- (stage I):
- 18 years ≤ age ≤ 50 years, male or female people;
- Body mass index is 18 kg/m\^2≤ BMI≤ 26kg/m\^2;
- people (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...
- 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...
- people are aware of the risks of the trial and voluntarily participate in this clinical trial and sign an informed consent form. (stage 2):
- Aged 18 to 75 years, inclusive, and of either gender.
- 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.
- One platelet test during the screening period and one during the baseline period (with an interval of at least 7 days), with an average platelet count \ 35×10\^9/L. No severe bleeding within 4 weeks prior to the...
- people who have previously failed at least one first-line standard ITP treatment (corticosteroids and/or intravenous immunoglobulin) (defined as inability to maintain how well it works or relapse), or are intolerant to...
- The study allows the concurrent use of the following ITP treatment medications at a stable dose: oral corticosteroids, danazol, dapsone, oral immunosuppressants (azathioprine, methotrexate, cyclosporine A, mycophenolate...
- The subject (including the subject's partner) is willing to use effective contraception from the time of signing the informed consent form until 3 months after the last dose of study drug, and has no plans for pregnancy...
- The subject fully understands and is able to comply with the requirements of the study protocol and voluntarily signs the informed consent form.
What rules you out
- \- (stage I)
- 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)...
- people 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; people with a combination of clinically...
- people have a history of immunodeficiency;
- people had a history of malignant tumors;
- people 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...
- 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);
- Those with clinically significant abnormalities on electrocardiogram (ECG) examination as judged by the clinical investigator (one repeat is permitted to determine eligibility);
- The subject has any condition that interferes with blood collection (including difficulties in blood sample collection, etc.);
- Consumption of more than 5 cups of coffee, tea, or cola (150mL each) per day in the 3 months prior to screening;
- Smoked more than 5 cigarettes or equivalent amount of tobacco per day in the 3 months prior to screening;
- Regular drinkers in the 6 months prior to screening, i.e., more than 2 units of alcohol per day (1 unit = 360mL of beer or 45mL of spirits at 40% alcohol or 150mL of wine) in the 6-month period; and abnormal breath test...
- people with a history of substance abuse within 1 year prior to screening; positive urine substance abuse screen at baseline;
- Blood loss or blood donation \>400mL within 3 months prior to screening or history of blood transfusion or any blood product use within 3 months prior to enrollment;
- Participation as a subject in any drug or vaccine or medical device clinical trial within 3 months prior to screening;
- Vaccinated or scheduled to be vaccinated within 4 weeks prior to screening up to 3 months after the end of dosing;
- Taken medications that may affect immune function within 6 months prior to screening or received any monoclonal antibody or biologic therapy within 3 months prior to screening and prescription/over-the-counter...
- Women who are pregnant or breastfeeding;
- people who, in the opinion of the investigator, have any factors that make participation in this trial inappropriate. (stage 2)
- Thrombocytopenia associated with other conditions such as lymphoma, chronic lymphocytic leukemia, viral infections, hepatitis, induced or alloimmune thrombocytopenia, thrombocytopenia associated with abnormal bone...
- Abnormalities in any of the following laboratory tests at screening or at baseline: a. Total IgG level \ 1.5 or activated partial thromboplastin time (APTT) \> 1.5 x ULN. c. Alanine aminotransferase (ALT) ≥ 3× ULN or...
- Clinical evidence of significantly unstable or poorly controlled acute or chronic disease other than ITP (e.g., cardiovascular, pulmonary, hematologic, gastrointestinal, endocrine, hepatic, renal, neurologic...
- Prior comorbidities or treatments: a. Use of anticoagulants (e.g., vitamin K antagonists, direct oral anticoagulants) or any medication with antiplatelet effects within 4 weeks prior to randomization. b. Any blood...
- Prior history of malignancy, except for cured carcinoma in situ.
- Any thrombotic or embolic event within 12 months prior to randomization, or history of any major thrombotic or embolic event within 5 years (e.g., myocardial infarction, stroke, deep vein thrombosis, or pulmonary...
- History of coagulation disorders or hereditary thrombocytopenia or family history of thrombocytopenia.
- Presence of active, clinically significant organ or internal mucosal bleeding requiring urgent treatment or therapeutic manipulation (e.g., intracranial hemorrhage, pulmonary hemorrhage, hemorrhage persistently...
- In the judgment of the investigator, it is predicted that there may be a higher risk of clinically significant organ or internal mucosal hemorrhage requiring urgent treatment or therapeutic manipulation during the study...
- Presence of clinically significant active or chronic bacterial, viral, or fungal infections at screening or at baseline; or acute or chronic infectious diseases requiring systemic therapy with antibiotics, antivirals...
- Hepatitis B surface antigen (HBsAg) positive at screening, or hepatitis B core antibody (HBcAb) positive+ Hepatitis B virus deoxyribonucleic acid (HBV-DNA) positive, or hepatitis C virus (HCV) antibody positive+...
- Currently has active tuberculosis, including pulmonary and extrapulmonary tuberculosis; chest X-ray reveals tuberculosis-related imaging changes in the lungs (e.g., cavities, infiltrative lesions).
- Hypersensitivity reactions to the study drug are known to exist.
- Participated in a clinical study of another FcRn inhibitor in the previous 6 months and received at least 1 administration.
- Have used the investigational drug within 3 months or 5 half-lives (whichever is longer) prior to randomization.
- Being pregnant or breastfeeding at screening or at baseline or having plans to become pregnant during the study.
- Presence of an autoimmune disease other than ITP at screening or at baseline.
- Other conditions that, in the judgment of the investigator, make participation in this study inappropriate.
The study team makes the final eligibility decision.
Where it's taking place
- Bengbu, Anhui, China
- Beijing, Beijing Municipality, China
- Tangshan, Hebei, China
- Zhengzhou, Henan, China
- Nanchang, Jiangxi, China
- Xi’an, Shanxi, China
- Tianjin, Tianjin Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bengbu, Anhui, China; Beijing, Beijing Municipality, China; Tangshan, Hebei, China; Zhengzhou, Henan, China; Nanchang, Jiangxi, China; Xi’an, Shanxi, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.