Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06534021
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
IASO-782 in Autoimmune Hematological Diseases
Sponsor:
None
Organization:
None
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 levels6mgkg and 10mgkg
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 levels6mgkg and 10mgkg
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None