Health TrialsbyHealthPanel

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

ConditionsAlzheimer DiseaseAlzheimer Disease, Early Onset
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorArrowhead Pharmaceuticals

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Body mass index between 18.0 and 35.0 kilograms (kg)/square meter (m²) 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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • ARO-MAPT-SC

    Drug

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

  • Placebo

    Drug

    • calculated volume to match active treatment by SC administration

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: ARO-MAPT-SCExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Through End of Study (EOS; Day 315)

Secondary outcomes

1

PK of ARO-MAPT-SC: Maximum Observed Plasma Concentration (Cmax)

Time frame
Through 48 hours postdose
2

PK of ARO-MAPT-SC: Time to Maximum Plasma Concentration (Tmax)

Time frame
Through 48 hours postdose
3

PK of ARO-MAPT-SC: Area Under the Plasma Concentration (AUC) Versus Time Curve From Time Zero to 24 Hours (AUC0-24)

Time frame
Through 24 hours postdose
4

PK of ARO-MAPT-SC: AUC Versus Time Curve From Time Zero to 48 Hours (AUC0-48)

Time frame
Through 48 hours postdose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Arrowhead Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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