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

Phase 1

• Conditions: Healthy; Alzheimer Disease
• Interventions: Drug: VG-3927; Drug: Placebo

• Registration Number: NCT06343636
• Lead Sponsor: Vigil Neuroscience, Inc.

Brief Summary

A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VG-3927 in Healthy Adults

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-27
• Study First Submitted: 2024-03-26
• Study First Submitted QC: 2024-03-26
• Study First Posted: 2024-04-02
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-07
• Last Update Posted: 2024-10-10
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 108

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single and Multiple Ascending Dose	VG-3927	Ascending single doses and multiple doses for healthy volunteers.
Placebo	Placebo	Matching placebo
Alzheimer's Disease	VG-3927	Single Dose Open-label

Primary Outcome Measures

Name	Time	Method
Adverse Events	28 days post last dose	To evaluate the safety and tolerability of VG-3927

Trial Locations

Locations (3)

K2 Medical Research; 🇺🇸 Maitland, Florida, United States

Nucleus Network; 🇦🇺 Melbourne, Australia

Clinical Pharmacology of Miami; 🇺🇸 Miami, Florida, United States