A Phase 1 Study of VG-3927 in Healthy Adults and Patients With Alzheimer's Disease

A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study in Healthy Adults and Open-label Single Dose Study in Patients with Alzheimer's Disease to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VG-3927.

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Key information

Conditions

Healthy Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network, Melbourne, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

The participant is deemed healthy by the principal investigator, as determined by prestudy medical evaluation
The participant voluntarily agrees to participate in this study and signs an institutional review board approved informed consent

Exclusion criteria

The participant has any concurrent disease or condition that, in the opinion of the principal investigator, would make the participant unsuitable for participation in the clinical study

Treatment and study plan

VG-3927

Drug

Dose Escalation

Placebo

Drug

Dose Escalation

Primary outcomes

Adverse Events

Time frame: 28 days post last dose

To evaluate the safety and tolerability of VG-3927

Sponsors and collaborators

Lead sponsor

Vigil Neuroscience, Inc.

Industry

Registry information

Official study title

A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study in Healthy Adults and Open-label Single Dose Study in Patients With Alzheimer's Disease to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VG-3927

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2025
First posted: Apr 2, 2024
Registry last updated: Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed