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)
Overview
- Phase
- Phase 1
- Intervention
- IASO-782 injection
- Conditions
- Autoimmune Thrombocytopenia
- Sponsor
- Shanghai IASO Biotechnology Co., Ltd
- Enrollment
- 16
- Primary Endpoint
- Number of participants with adverse events as assessed by CTCAE v5.0
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief 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).
Detailed Description
This study is a single-dose escalation study in subjects with autoimmune hematological diseases. The study is designed to enroll subjects with autoimmune thrombocytopenia and warm antibody type immune haemolytic anaemia (ITP and wAIHA). Referred to the clinical pharmacological study and development experience of similar drugs, one or more dose regimens will be determined for the use in Phase 1b clinical trials. This study will evaluate the safety and preliminary dose range of IASO-782 in subjects with autoimmune hematologic diseases (ITP and wAIHA) at the following dose levels:6mg/kg and 10mg/kg.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-65 years
- •Clinically confirmed diagnosis of autoimmune thrombocytopenia (ITP) or warm autoimmune haemolytic anaemia (wAIHA)
- •Failure or relapse after at least 1 treatment for the study disease
- •Stable dose of immunosuppressants for 4 weeks before screening
- •Organ function or laboratory test is basically normal
- •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)
- •Females of potential childbearing capacity must have a negative pregnancy test at screening
- •Voluntarily participate in this study and sign the informed consent
Exclusion Criteria
- •History of other primary malignant neoplasm within 5 years of screening
- •Secondary to other disease-induced hematopoietic destruction
- •Cardiac disorder within the last 3 months
- •Patients with high blood pressure that cannot be controlled by drug
- •Subjects with a history of allergy to any component of the investigational drug
- •Active infection requiring intravenous treatment within 30 days prior to the enrollment
- •Pregnant or breastfeeding women
- •Participation was being given other investigational drug within 30 days or 5 half-lives (whichever is longer) prior to administration of the investigational drug
- •Previous treatment drugs have not been adequately washed out
- •ITP patients have had any previous arterial or venous thrombosis
Arms & Interventions
Experimental group
Drug:IASO-782 injection Dosage and Administration: single dose of IASO-782, 6 mg/kg or 10 mg/kg , intravenous injection at day 1
Intervention: IASO-782 injection
Control group
Drug:placebo Dosage and Administration: single dose of placebo, intravenous injection at day 1
Intervention: placebo
Outcomes
Primary Outcomes
Number of participants with adverse events as assessed by CTCAE v5.0
Time Frame: up to 12 weeks
The safety and tolerability of IASO-782 will be assessed primarily by summarizing treatment-emergent AEs and SAEs.