Study of ARO-MAPT-SC in Healthy Subjects and Subjects With Early Alzheimer's Disease

Not Applicable

Not yet recruiting

• Conditions: Alzheimer Disease; Alzheimer Disease, Early Onset
• Interventions: Drug: ARO-MAPT-SC; Drug: Placebo

• Registration Number: NCT07221344
• Lead Sponsor: Arrowhead Pharmaceuticals

Brief Summary

Study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of ARO-MAPT-SC compared to placebo in adult healthy volunteers and in participants with early Alzheimer's disease (AD), defined as mild cognitive impairment due to AD and mild AD dementia.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-23
• Study First Submitted QC: 2025-10-23
• Last Update Submitted: 2025-10-23
• Study First Posted: 2025-10-27
• Last Update Posted: 2025-10-27
• Study Start: 2025-11-01
• Primary Completion: 2027-06
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
ARO-MAPT-SC	ARO-MAPT-SC	ARO-MAPT-SC injection
Placebo	Placebo	Sterile normal saline (0.9%)

Primary Outcome Measures

Name	Time	Method
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Over Time	Through End of Study (EOS), Day 270

Secondary Outcome Measures

Name	Time	Method
PK of ARO-MAPT-SC: Maximum Observed Plasma Concentration (Cmax)	Through 48 hours postdose
PK of ARO-MAPT-SC: Time to Maximum Plasma Concentration (Tmax)	Through 48 hours postdose
PK of ARO-MAPT-SC: Area Under the Plasma Concentration (AUC) Versus Time Curve From Time Zero to 24 Hours (AUC0-24)	Through 24 hours postdose
PK of ARO-MAPT-SC: AUC Versus Time Curve From Time Zero to 48 Hours (AUC0-48)	Through 48 hours postdose
PK of ARO-MAPT-SC: AUC Versus Time Curve From Time Zero to the Last Quantifiable Plasma Concentration (AUC0-t)	Through 48 hours postdose
PK of ARO-MAPT-SC: AUC Versus Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf)	Through 48 hours post-dose
PK of ARO-MAPT-SC: Apparent Terminal Elimination Half-life (t1/2)	Through 48 hours postdose
PK of ARO-MAPT-SC: Apparent Systemic Clearance (CL/F)	Through 48 hours postdose
PK of ARO-MAPT-SC: Apparent Terminal-phase Volume of Distribution (Vz/F)	Through 48 hours postdose
PK of ARO-MAPT-SC: Amount Excreted (Ae) of Unchanged Drug in Urine From Time Zero to 24 Hours Postdose	Through 24 hours postdose
PK of ARO-MAPT-SC: Percentage of Administered Drug Recovered (Fe) in Urine From Time Zero to 24 Hours Postdose	Through 24 hours postdose
PK of ARO-MAPT-SC: Renal Clearance (CLR)	Through 24 hours postdose
Change from Baseline in Total Protein in Cerebral Spinal Fluid (CSF) Over Time	Baseline through EOS, Day 270
Change from Baseline in Glucose in CSF Over Time	Baseline through EOS, Day 270
Change from Baseline in Cell Count in CSF Over Time	Baseline through EOS, Day 270