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

NCT06753955 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2026-04-27

No results posted yet for this study

Summary

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of ART5803 following IVIG administration in healthy participants to investigate the potential interactions between ART5803 and IVIG

Conditions

  • Autoimmune Encephalitis Caused by N-Methyl D-Aspartate Receptor Antibody
  • Autoimmune 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

Sponsors & Collaborators

  • Arialys Therapeutics

    lead INDUSTRY

Principal Investigators

  • Sankalp Gokhale, MD, MBA · Arialys Therapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-02-25
Primary Completion
2025-07-02
Completion
2025-08-19

Countries

  • Australia

Study Locations

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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 NCT06753955 on ClinicalTrials.gov