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Phase 1 Study of ART5803 in Healthy Participants

NCT06575153 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2026-04-27

No results posted yet for this study

Summary

The study is a Phase 1, single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to assess the safety, tolerability, pharmacokinetics (PK), and immunogenicity of ART5803 compared with placebo in healthy adult participants

Conditions

  • 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.

Sponsors & Collaborators

  • Arialys Therapeutics

    lead INDUSTRY

Principal Investigators

  • Sankalp Gokhale, MD, MBA · Arialys Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2024-09-19
Primary Completion
2025-09-11
Completion
2025-10-31

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 NCT06575153 on ClinicalTrials.gov