NCT06750432

PMN310 in Patients With Early Alzheimer's Disease (PRECISE-AD)

A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PMN310 in Patients With Early Alzheimer's Disease

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 144 (estimated)
• Sponsor: ProMis Neurosciences, Inc · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This Phase 1b study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of multiple IV infusions of PMN310 in patients with early Alzheimer's disease.

Detailed description

This study is a Phase 1b, randomized, double-blind, placebo controlled, multi-ascending dose study of repeat doses of PMN310 to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of multiple intravenous infusions of PMN310 in patients with early Alzheimer's disease. This study will evaluate 3 dose levels (350 mg, 700 mg, and 1400 mg are planned). Patients will be randomly assigned 3:1, PMN310: placebo. Each patient will receive PMN310 or placebo once every 28 days for a total of 12 infusions.

Conditions

• Alzheimer Disease, Early Onset

Interventions

Type	Name	Description
DRUG	PMN310	A humanized immunoglobulin G1 (IgG1) monoclonal antibody
DRUG	Placebo	0.9% NaCl 100 mL

Timeline

• Start date: 2024-12-13
• Primary completion: 2026-12-01
• Completion: 2026-12-01
• First posted: 2024-12-27
• Last updated: 2025-12-24

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study