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NCT06534021

PHASE1

IASO-782 in Autoimmune Hematological Diseases

Sponsor: Shanghai IASO Biotechnology Co., Ltd

View on ClinicalTrials.gov

Summary

This study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with autoimmune hematological diseases. The study is designed to assess the safety and tolerability of IASO-782 for the treatment of autoimmune haematological diseases (ITP and wAIHA).

Official title: A Phase Ia Study to the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of IASO-782 in Patient With Autoimmune Hematological Diseases (Autoimmune Thrombocytopenia and Warm Antibody Type Autoimmune Hemolytic Anemia)

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-08-01

Completion Date

2025-11-01

Last Updated

2024-08-01

Healthy Volunteers

Conditions

Autoimmune Thrombocytopenia Warm Autoimmune Haemolytic Anaemia

Interventions

DRUG

IASO-782 injection

Each subject will be given only one dose of IASO-782. Subjects should avoid strenuous exercise within 48 h before administration and remain seated or semi-recumbent (except for necessary activities) for 4 h after administration. IASO-782 solution for injection or placebo was diluted in 0.9% sodium chloride injection (corresponding to the dose administered according to the body weight at baseline and the dose group) with a total volume of 250 mL, administered as a single intravenous drip at a drip rate recommended by the drug manual on the day of administration, The infusion time is about 90 minutes (± 15 minutes).

DRUG

placebo

Each subject will be given one dose of placebo. Subjects should avoid strenuous exercise within 48 h before administration and remain seated or semi-recumbent (except for necessary activities) for 4 h after administration. IASO-782 solution for injection or placebo was diluted in 0.9% sodium chloride injection (corresponding to the dose administered according to the body weight at baseline and the dose group) with a total volume of 250 mL, administered as a single intravenous drip at a drip rate recommended by the drug manual on the day of administration, The infusion time is about 90 minutes (± 15 minutes).

Inclusion Criteria: 1. Age 18-65 years 2. Clinically confirmed diagnosis of autoimmune thrombocytopenia (ITP) or warm autoimmune haemolytic anaemia (wAIHA) 3. Failure or relapse after at least 1 treatment for the study disease 4. Stable dose of immunosuppressants for 4 weeks before screening 5. Organ function or laboratory test is basically normal 6. Subjects of childbearing potential and their partners must use effective contraception for at least 2 weeks before administration of investigational product, throughout the trial period, and for 28 days after the end of the trial (or early termination of the trial) 7. Females of potential childbearing capacity must have a negative pregnancy test at screening 8. Voluntarily participate in this study and sign the informed consent Exclusion Criteria: 1. History of other primary malignant neoplasm within 5 years of screening 2. Secondary to other disease-induced hematopoietic destruction 3. Cardiac disorder within the last 3 months 4. Patients with high blood pressure that cannot be controlled by drug 5. Subjects with a history of allergy to any component of the investigational drug 6. Active infection requiring intravenous treatment within 30 days prior to the enrollment 7. Pregnant or breastfeeding women 8. Participation was being given other investigational drug within 30 days or 5 half-lives (whichever is longer) prior to administration of the investigational drug 9. Previous treatment drugs have not been adequately washed out 10. ITP patients have had any previous arterial or venous thrombosis 11. Patients with ITP had previous biopsy bone marrow results indicating bone marrow fibrosis (Myelofibrosis MF) ≥ 2 12. Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C (HCV) infection; or diagnosis of immunodeficiency that is related to, or results in chronic infection, as described in the protocol 13. Subjects with a history of drug abuse or mental disorder 14. Other medical history or conditions that would make the subject unsuitable for the study by investigators' judge.

Clinical Research Directory

IASO-782 in Autoimmune Hematological Diseases

Summary

Key Details

Conditions

Interventions

Eligibility Criteria