Phase 1 Study of ART5803 to Assess Safety and Tolerability in Healthy Participants
NCT Number: NCT06575153
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Autoimmune Encephalitis
Interventions: DRUG: ART5803
Sponsor: Arialys Therapeutics
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 40
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-09-30
Completion Date: 2025-08-08
Locations: Nucleus Network Pty Ltd, Melbourne, Victoria, 3004, Australia

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

Primary Outcome Measures: Safety will be assessed by the incidence and severity of treatment-emergent adverse events (TEAEs), ART5803 safety, as measured by the number of treatment emergent adverse events compared with placebo., 12 weeks|Safety will be assessed by clinically significant changes in physical and neurological examination findings, ART5803 safety, will be assessed by clinically significant changes in physical and neurological examination findings compared with placebo., 12 weeks|Safety by assessed by clinically significant changes in vital signs, ART5803 safety, will be assessed by clinically significant changes in vital signs including systolic and diastolic blood pressure, pulse rate, respiration rate, and body temperature as compared to placebo., 12 weeks|Safety by assessed by clinically significant changes in clinical laboratory outcomes, ART5803 safety, will be assessed by clinically significant changes in clinical laboratory outcomes including clinical chemistry, hematology, coagulation, and urinalysis as compared to placebo., 12 weeks|Safety by assessed by clinically significant changes in 12-lead ECG findings, ART5803 safety, will be assessed by clinically significant changes 12-lead ECG findings as compared to placebo., 12 weeks|Safety by assessed by clinically significant changes in concomitant medications, ART5803 safety, will be assessed by clinically significant changes in concomitant medications as compared to placebo., 12 weeks|Safety by assessed by clinically significant changes in presence of anti-drug antibodies (ADAs), ART5803 safety, will be assessed by clinically significant changes in presence of anti-drug antibodies (ADAs) as compared to placebo., 12 weeks|Safety will be assessed by incidence of dose-limiting toxicity (DLTs), ART5803 safety, will be assessed by incidence of dose-limiting toxicity (DLTs) as compared to placebo., 12 weeks|Safety will be assessed by change in suicidal tendency measured by Columbia-Suicide Severity Rating Scale (C-SSRS), ART5803 safety, will be assessed by change in suicidal tendency as measured by the incidence of positive responses (Yes) to Item 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) as compared to placebo., 12 weeks
Secondary Outcome Measures: To assess the pharmacokinetics (PK) of single ascending IV doses of ART5803 compared with placebo, To characterize and compare the PK profile of single ascending IV doses of ART5803 as measured by maximum concentration (Cmax) as compared with placebo., Serum collected over 96 hours after administration, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, and Day 85; CSF collected 48 hours after administration, Day 29 and Day 57|To assess the pharmacokinetics (PK) of single ascending IV doses of ART5803 compared with placebo, To characterize and compare the PK profile of single ascending IV doses of ART5803 as measured by minimum concentration (Cmin) as compared with placebo., Serum collected over 96 hours after administration, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, and Day 85; CSF collected 48 hours after administration, Day 29 and Day 57|To assess the pharmacokinetics (PK) of single ascending IV doses of ART5803 compared with placebo, To characterize and compare the PK profile of single ascending IV doses of ART5803 as measured by time at which Cmax is observed (tmax) as compared with placebo., Serum collected over 96 hours after administration, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, and Day 85; CSF collected 48 hours after administration, Day 29 and Day 57|To assess the pharmacokinetics (PK) of single ascending IV doses of ART5803 compared with placebo, To characterize and compare the PK profile of single ascending IV doses of ART5803 as measured by area under the curve from time 0 to the last measurable concentration (AUC0-t) as compared with placebo., Serum collected over 96 hours after administration, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, and Day 85; CSF collected 48 hours after administration, Day 29 and Day 57|To assess the pharmacokinetics (PK) of single ascending IV doses of ART5803 compared with placebo, To characterize and compare the PK profile of single ascending IV doses of ART5803 as measured by area under the curve from time 0 extrapolated to infinity (AUC0-∞) as compared with placebo., Serum collected over 96 hours after administration, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, and Day 85; CSF collected 48 hours after administration, Day 29 and Day 57|To assess the pharmacokinetics (PK) of single ascending IV doses of ART5803 compared with placebo, To characterize and compare the PK profile of single ascending IV doses of ART5803 as measured by the half-life (t½) as compared with placebo., Serum collected over 96 hours after administration, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, and Day 85; CSF collected 48 hours after administration, Day 29 and Day 57|To assess the pharmacokinetics (PK) of single ascending IV doses of ART5803 compared with placebo, To characterize and compare the PK profile of single ascending IV doses of ART5803 as measured by the volume of distribution (Vd) as compared with placebo., Serum collected over 96 hours after administration, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, and Day 85; CSF collected 48 hours after administration, Day 29 and Day 57|To assess the pharmacokinetics (PK) of single ascending IV doses of ART5803 compared with placebo, To characterize and compare the PK profile of single ascending IV doses of ART5803 as measured by clearance (CL) as compared with placebo., Serum collected over 96 hours after administration, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, and Day 85; CSF collected 48 hours after administration, Day 29 and Day 57|To assess the pharmacokinetics (PK) of single ascending IV doses of ART5803 compared with placebo, To asses the CSF/serum ratio of ART5803 at multiple time points., Serum collected over 96 hours after administration, Day 8, Day 15, Day 29, Day 43, Day 57, Day 71, and Day 85; CSF collected 48 hours after administration, Day 29 and Day 57
Other Outcome Measures: To assess changes in cognition as measured by the Mini-Mental State Examination (MMSE) after single ascending IV doses of ART5803 compared with placebo, To assess the change in MMSE total scores from baseline as compared with placebo., Day 1 (pre-dose), 24 hours after administration, Day 8, Day 29, Day 57, and Day 85|To assess changes in cognition as measured by the Trial Making Test Part A & B (TMT-A and TMT-B) after single ascending IV doses of ART5803 compared with placebo, To assess the change in TMT-A and TMT-B total scores from baseline as compared with placebo., Day 1 (pre-dose), 24 hours after administration, Day 8, Day 29, Day 57, and Day 85|To assess the immunogenicity of single ascending IV doses of ART5803 compared with placebo, To assess the incidence of anti-drug antibodies (ADAs) in serum from single ascending IV doses of ART5803 as compared with placebo, Day 1 (pre-dose), Day 8, Day 29, Day 43, Day 71, and Day 85