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IASO-782 in Autoimmune Hematological Diseases

NCT06534021 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-08-01

No results posted yet for this 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).

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).

Sponsors & Collaborators

  • Shanghai IASO Biotechnology Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Heng Mei · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-01
Primary Completion
2025-11-01
Completion
2025-11-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06534021 on ClinicalTrials.gov