A Phase Ib/II Clinical Trial of Multiple Doses of STSA-1301 Subcutaneous Injection in Healthy Subjects and Patients With Immune Thrombocytopenia (ITP)

NCT06929299 | Recruiting Phase 1

• 1 other identifier: STSA-1301-02
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 7

Brief 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

Conditions

Primary Immune Thrombocytopenia (ITP)

Outcome Measures

Primary Outcomes (1)

• To Evaluate any adverse event that occurs in the subject after administration of the drug

  78 Days

Secondary Outcomes (21)

• Pharmacodynamic (PD) indicators: Serum total IgG

  78 days

• Proportion of subjects achieving a platelet count ≥30× 10^9/L at least 2 times within 11 weeks of the first administration of the drug

  78 days

• Proportion of subjects achieving a response (R) within 11 weeks of first dosing

  78 days

• Proportion of subjects achieving a complete response (CR) within 11 weeks of initial dosing

  78 days

• Proportion of subjects achieving a platelet count ≥50× 10^9/L at least 2 times within 11 weeks of the first administration of the drug

  78 days

Study Arms (3)

Low dose of STSA-1301 subcutaneous injection or Placebo (First cohort)

EXPERIMENTAL

Drug: STSA-1301 subcutaneous injection; Drug: Placebo

Median dose of STSA-1301 subcutaneous injection or Placebo (Second cohort)

EXPERIMENTAL

Drug: STSA-1301 subcutaneous injection; Drug: Placebo

High dose of STSA-1301 subcutaneous injection or Placebo (Third cohort)

EXPERIMENTAL

Drug: STSA-1301 subcutaneous injection; Drug: Placebo

Interventions

STSA-1301 subcutaneous injection DRUG

Subjects will receive the STSA-1301 on the dates specified in the protocol

High dose of STSA-1301 subcutaneous injection or Placebo (Third cohort); Low dose of STSA-1301 subcutaneous injection or Placebo (First cohort); Median dose of STSA-1301 subcutaneous injection or Placebo (Second cohort)

Placebo DRUG

Subjects will receive the placebo on the dates specified in the protocol

High dose of STSA-1301 subcutaneous injection or Placebo (Third cohort); Low dose of STSA-1301 subcutaneous injection or Placebo (First cohort); Median dose of STSA-1301 subcutaneous injection or Placebo (Second cohort)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- (stage I):
• 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.
• (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 \<30×10\^9/L and no single platelet count \>35×10\^9/L. No severe bleeding within 4 weeks prior to the screening visit.
• Subjects who have previously failed at least one first-line standard ITP treatment (corticosteroids and/or intravenous immunoglobulin) (defined as inability to maintain efficacy or relapse), or are intolerant to first-line standard treatment.
• 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 mofetil), or TPO-RA (limited to oral small molecule non-peptide). A stable dose means that the treatment dose and frequency have been stable for at least 4 weeks prior to randomization and are not expected to change during the study.
• 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 or sperm/egg donation during this period.
• The subject fully understands and is able to comply with the requirements of the study protocol and voluntarily signs the informed consent form.

You may not qualify if:

• \- (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) 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);
• 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 results for alcohol during the Screening Period or Baseline Period;
• Subjects with a history of substance abuse within 1 year prior to screening; positive urine substance abuse screen at baseline;

Sponsors & Collaborators

• Jiangsu BioJeTay Biotechnology Co., Ltd.: lead

Study Sites (7)

The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, 233000, China

RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 101109, China

RECRUITING

North China University of Science and Technology Affiliated Hospital

Tangshan, Hebei, 063000, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 475000, China

RECRUITING

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, 330000, China

RECRUITING

Xi'an Central Hospital

Xi’an, Shanxi, 710000, China

RECRUITING

Hospital of Hematology, Chinese Academy of Medical Sciences

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Lei Zhang, M.D.

  Hospital of Hematology, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

• Yi Fang, Ph.D

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanli Wang

CONTACT

+86 13311367132; wangyanli@staidson.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2025
• First Posted: April 16, 2025
• Study Start: May 12, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2025-05

Locations

CN (7)