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NCT03822208 · ClinicalTrials.gov registry record · Phase 1

First in Human Study for Safety and Tolerability of AL003.

A Phase 1 study, sponsored by Alector.

Completed
Registry status
Phase 1
Development phase
54
Enrollment target

NCT03822208: Completed Phase 1 study, sponsored by Alector.

NCT03822208 is a Phase 1 study that has completed, run by Alector. The registered enrollment target is 54 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03822208, a Phase 1 study, has completed, sponsored by Alector.

COMPLETED
Registry status
Phase 1
Development phase
54 participants
Enrollment target

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.

Primary Outcome

Incidence of adverse events during the treatment and follow up periods through out the study.

Interventions

  • OTHER Saline Solution
  • BIOLOGICAL AL003

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2019-03-29
Est. Completion 2021-05-06
Phase Phase 1
Alector

10 total trials

What the finished NCT03822208 record still lists

NCT03822208 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (10% lower).

The record links to 0 conditions, and to 2 interventions - of which Saline Solution is the first listed.

NCT03822208 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03822208 about?

NCT03822208 is a clinical study titled "First in Human Study for Safety and Tolerability of AL003.". 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, pharmac...

What is the current status of trial NCT03822208?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2019-03-29. Estimated completion is 2021-05-06.

What interventions are being tested in trial NCT03822208?

The interventions under investigation include: Saline Solution (OTHER), AL003 (BIOLOGICAL).

Who is sponsoring clinical trial NCT03822208?

This trial is sponsored by Alector, which has 10 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03822208's enrollment target sits among peer trials

54 931st of 2000 higher than 1,053 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03822208, the US trial registry maintained by the National Library of Medicine. NCT03822208 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.