Study of ARO-MAPT-SC in Healthy Participants and Participants With Early Alzheimer's Disease
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
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
Treatments tested in this trial
- ARO-MAPT-SC
- Placebo
Treatment groups
112 Participants
are divided into 2 treatment groupsLocations
3Canada
Research Site 3M4G 3E8, East YorkOntario, Canada
Research Site 2M3B2S7, TorontoOntario, Canada
New Zealand
Research Site 11010, GraftonAuckland, New Zealand
Sponsors and collaborators
Arrowhead Pharmaceuticals
Lead sponsor
Source ClinicalTrials.gov