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Clinical Trials
Clinical Trial of AL04

Plans for Clinical Trial (Phase 1)

01
L&J submitted the Pre-IND
package to US FDA

Application Number-PIND 163731

02
The primary objective

Evaluate the safety and tolerability of a range of AL04 doses
administered as single intravenous (IV) infusions in participants
with mild to moderate AD

03
Secondary Objectives

Assess the pharmacokinetics (PK) and to evaluate the immunogenicity
of AL04 after single-dose administration

Single ascending doses study Multiple ascending doses study
Official title A Randomized, Blinded, Placebo-Controlled Single Ascending Doses Study for the Safety, Tolerability, and Pharmacokinetics of AL04 in normal volunteers A Randomized, Blinded, Placebo-Controlled Multiple Ascending Doses Study for the Safety, Tolerability, and clinical progression of AL04 in Subjects with Mild to Moderate Alzheimer's Disease
Actual enrollment 24 participants (2 placebo + 6 AL04), 3 cohorts 24 participants (2 placebo + 6 AL04), 3 cohorts
Dosage form Single injection Multiple injection (12 injection/dose)
Study type Interventional (Clinical trial)
Allocation Randomized
Intervention model Single group assignment
Masking Double (Participant, Investigator)
Primary purpose Treatment