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NCT06343636 Clinical Trial

A Phase 1 Study of VG-3927 in Healthy Adults

Healthy Clinical Trial

Official title:
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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT06343636
Other study ID # VG3927-02.101
Secondary ID
Status Enrolling by invitation
Phase Phase 1
First received
Last updated
Start date September 27, 2023
Est. completion date December 31, 2024

Study information
Verified date February 2024
Source Vigil Neuroscience, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 90
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• VG-3927
Dose Escalation
• Placebo
Dose Escalation

Locations
Country Name City State
United States Clinical Pharmacology of Miami Miami Florida

Sponsors (1)
Lead Sponsor Collaborator
Vigil Neuroscience, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse Events To evaluate the safety and tolerability of VG-3927 28 days post last dose
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