Phase 1 Study to Evaluate the Safety and Tolerability of 8M2D in Healthy People and Alzheimer's Patients

Trial Rationale: This is a three-part Phase 1a/b clinical trial. Phase Ia is a first-in-human (FIH), 2-part (Part I \[SAD\] and Part II \[MAD\]) clinical trial designed to evaluate the safety, tolerability, pharmacokinetics (PK), and exploratory immunogenicity of single and multiple doses of 8M2D in healthy participants. Phase Ib will consist of Part III (Alzheimer's Disease \[AD\]), designed to evaluate the safety, tolerability, PK, exploratory immunogenicity, and pharmacodynamics (PD) of multiple doses of 8M2D in participants with early AD. Data from this trial will be used to identify doses of 8M2D that show safety and tolerability and PD effects on amyloid beta (Aβ), to aid in the design of future trials in patients with AD. Prior to this trial, 8M2D has not been administered to humans. Safety and tolerability evaluations will be conducted over a range of single and multiple doses of 8M2D and dose escalation will not proceed until safety and tolerability data and PK parameters from previous doses have been reviewed by an independent Data and Safety Monitoring Board (DSMB). This trial will aim to assess a maximum-tolerated dose (MTD), or a maximum feasible dose (based on tolerability of the subcutaneous \[SC\] injections), or a maximum pharmacologically active dose, based on safety, tolerability and PK data as well as on model-based prediction of the anticipated Aβ lowering. The data generated in this trial will be used to help design subsequent clinical trials in participants with early AD.