About this trial
This study will evaluate the safety, tolerability, preliminary efficacy and pharmacokinetics (PK) of ART5803 in adult participants with a confirmed diagnosis of anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis (ANRE) or anti-NMDAR autoantibody-associated psychiatric disease
Eligibility criteria
Qualifiers
None
Disqualifiers
The participant is a male or female who is of legal age to provide informed consent per local regulations, and ≤65 years of age at the time of informed consent. For the purposes of this study, the minimum age is 19 years in South Korea and 18 years in Australia.
The participant, or their legally authorized representative (LAR), must be willing and able to provide written, signed informed consent after the nature of the study has been explained, and prior to any research-related procedures. For participants who are unable to sign the consent form themselves, informed consent must be obtained from their LAR in accordance with local regulations and ethical guidelines.
The participant, or their LAR, must ensure willingness and ability to comply with all study procedures to the extent possible, as determined by the Investigator.
The participant has a diagnosis of ANRE according to the Graus et al criteria (Graus et al, 2016), with symptom onset >9 months to ≤36 months (or ≤120 months with Sponsor approval) prior to Week 0, Day 0.
Trial design
Treatments tested in this trial
- ART5803
- ART5803-Cohort D
Treatment groups
Sponsors and collaborators
Arialys Australia Pty Ltd
Lead sponsor
Arialys Therapeutics
Collaborator
Seoul National University Hospital
Collaborator