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).
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).
Study 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).
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Number of participants with adverse events as assessed by CTCAE v5.0 — up to 12 weeks The safety and tolerability of IASO-782 will be assessed primarily by summarizing treatment-emergent AEs and SAEs.
Trial sites (2)
Facility
City
Region
Status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Hubei
Recruiting
Institute of Hematology, Chinese Academy of Medical Sciences
Tianjin
Tianjin Municipality
Recruiting
More Shanghai IASO Biotechnology Co., Ltd trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.