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A Phase I Study for Safety and Tolerability of AL002.

NCT03635047 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2020-12-09

No results posted yet for this study

Summary

This is a multi-centre, 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 AL002.

Conditions

  • Healthy
  • Alzheimer Disease

Interventions

BIOLOGICAL

AL002

Single-doses of AL002 in up to 9 dose-escalating cohorts

OTHER

Saline Solution

Saline solution will be administered as a single infusion for each cohort in a ratio of 6 active and 2 placebo subjects for HV and 10 active and 2 placebo for patients

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
2018-11-12
Primary Completion
2020-08-03
Completion
2020-11-25
FDA Drug
Yes

Countries

  • United States
  • Australia
  • United Kingdom

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 NCT03635047 on ClinicalTrials.gov