Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575153
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Phase 1 Study of ART5803 in Healthy Participants
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Randomized Double-blind Single Ascending Dose Study to Assess the Safety and Tolerability of ART5803 Compared With Placebo in Healthy Participants
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is a Phase 1 single-center randomized double-blind placebo-controlled single ascending dose SAD study to assess the safety tolerability pharmacokinetics PK and immunogenicity of ART5803 compared with placebo in healthy adult participants
Detailed Description:
Anti-N-methyl-D-aspartate receptor NMDAR encephalitis is one of the most common causes of autoimmune encephalitis The disease is caused by the development of autoantibodies against the amino N-terminal domain NTD of the NMDAR subunit 1 NR1 that bind and cross link the receptors leading to receptor internalization and loss of function Arialys has developed a monovalent one-armed antibody ART5803 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 This first-in-human FIH study will assess the safety tolerability pharmacokinetics PK and immunogenicity of ART5803 compared with placebo in healthy participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None