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First in Human Study for Safety and Tolerability of AL003.

NCT03822208 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2021-09-17

No results posted yet for this study

Summary

This is a multi-center, randomized, double-blind, placebo-controlled, dose escalation first in human (FIH) study in healthy adults and in patients with mild to moderate Alzheimer's disease. The study is designed to systematically assess the safety (including immunogenicity) and tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AL003.

Conditions

  • Healthy
  • Alzheimer Disease

Interventions

BIOLOGICAL

AL003

Single-doses of AL003 in dose-escalating cohorts Multiple doses of AL003 in a single cohort

OTHER

Saline Solution

Saline Solution will be administered as a single infusion for each dose escalation cohort in a ratio of 6 active and 2 placebo and as multiple infusions in the single cohort in a ratio of 10 active and 2 placebo

Sponsors & Collaborators

  • Alector Inc.

    lead INDUSTRY

Principal Investigators

  • Robert Paul, MD · Alector Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-29
Primary Completion
2021-05-06
Completion
2021-05-06
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03822208 on ClinicalTrials.gov