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

NCT07221344 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: AROMAPT-SC-1001
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; Alzheimer Disease, Early Onset

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Treatment-Emergent Adverse Events (TEAEs) Over Time

  Through End of Study (EOS), Day 270

Secondary Outcomes (15)

• 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

Study Arms (2)

ARO-MAPT-SC

EXPERIMENTAL

ARO-MAPT-SC injection

Drug: ARO-MAPT-SC

Placebo

PLACEBO COMPARATOR

Sterile normal saline (0.9%)

Drug: Placebo

Interventions

ARO-MAPT-SC DRUG

• single or multiple doses of ARO-MAPT-SC by subcutaneous (SC) injection

ARO-MAPT-SC

Placebo DRUG

• calculated volume to match active treatment by SC administration

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body mass index between 18.0 and 35.0 kg/m\^2 at Screening
• Not pregnant or breast-feeding
• Able and willing to provide written informed consent prior to the performance of any study specific procedures
• Participants of childbearing potential must agree to use highly effective contraception in addition to a condom during the study and for at least 90 days following the end of the study or last dose of study drug, whichever is later; participants must not donate sperm or eggs during the study and for at least 90 days following the end of the study or last dose of study drug whichever is later
• Adults aged 50 to 80 years of age with a clinical diagnosis of early AD and plasma, CSF, or imaging biomarkers consistent with the diagnosis
• On stable doses of AD-related medications for at least 8 weeks prior to Screening Visit and throughout the Screening period until Day 1
• Have a reliable and competent caregiver or trial partner who is ≥18 years of age, able and willing to accompany the participant to study visits involving informant-based assessments, to be available to site staff by telephone as needed, and in the opinion of the Investigator, be sufficiently familiar with the participant throughout the study in order to provide accurate and reliable information relevant to study outcome measures

You may not qualify if:

• Blood pressure outside of specified range in the protocol
• Human immunodeficiency virus (HIV) infection (seropositive at Screening)
• Seropositive for hepatitis B (HBV) or hepatitis C (HCV) at Screening
• Intellectual disability or significant behavioral neuropsychiatric manifestation
• Clinically significant cardiac, liver, or renal disease
• Any contraindications to lumbar puncture
• Known allergy or possible allergy to either ARO-MAPT-SC or to its excipients

Sponsors & Collaborators

• Arrowhead Pharmaceuticals: lead

Study Sites (1)

Research Site 1

Grafton, Auckland, 1010, New Zealand

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Medical Monitor

CONTACT

626-304-3400; AROMAPT-SC-1001@arrowheadpharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2025
• First Posted: October 27, 2025
• Study Start: November 18, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NZ (1)