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NOT YET RECRUITING
NCT07816341
PHASE1

Phase 1 Study of F182112 in Relapsed/Refractory Autoimmune Hemolytic Anemia

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

This is an open-label, phase I clinical study of F182112 in patients with relapsed or refractory autoimmune hemolytic anemia (AIHA). Participants will receive F182112 at different dose levels. The main purpose of the study is to evaluate the safety and tolerability of F182112 and to identify an appropriate dose for further clinical development.

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Preliminary Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of F182112 in Patients With Relapsed/Refractory Autoimmune Hemolytic Anemia

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2026-10-10

Completion Date

2028-12-31

Last Updated

2026-09-11

Healthy Volunteers

No

Interventions

DRUG

F182112 single-agent

The dose-escalation phase will evaluate three sequential target dose levels of F182112: 30 μg/kg, 90 μg/kg, and 180 μg/kg, using a standard 3+3 design. F182112 will be administered intravenously using a priming dose followed by a target dose.

Locations (1)

Red Blood Cell Diseases Center and Regenerative Medicine Center

Tianjin, Tianjin Municipality, China