Phase 1 Study of ART5803 Safety and PK After IVIG in Healthy Participants

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

6

Participants

Timeline

Start Date

March 18, 2025

Primary Completion Date

August 19, 2025

Study Completion Date

December 24, 2025

Conditions
Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor AntibodyAutoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody (Disorder)Autoimmune Encephalitis
Interventions
DRUG

ART5803

A monovalent (one-armed) antibody, that binds to the NTD of the NMDAR NR1 subunit without causing NMDAR inhibition, activation, or receptor internalization, while simultaneously blocking the ability of the pathogenic anti-NMDAR autoantibodies to bind to the receptor.

DRUG

Intravenous immunoglobulin (IVIG)

Administered as background treatment prior to the investigational product

Trial Locations (1)

3004

Nucleus Network Pty Ltd, Melbourne

Sponsors
All Listed Sponsors
lead

Arialys Therapeutics

INDUSTRY