VG-3927 for Healthy Adults

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vigil Neuroscience, Inc.

Disqualifiers: Concurrent disease or condition

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

115 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for healthy adults who have agreed to participate and signed a consent form. They must be considered healthy by the study's doctor, based on medical evaluations done before the study starts.

Inclusion Criteria

Participant voluntarily agrees to participate in this study and signs an institutional review board approved informed consent

Participant is deemed healthy by the principal investigator, as determined by prestudy medical evaluation

Exclusion Criteria

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ascending single and multiple doses of VG-3927 or placebo, and Alzheimer's patients receive a single open-label dose

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• VG-3927

Trial Overview The trial is testing VG-3927, a new drug, in its first use in humans. Participants will either receive VG-3927 or a placebo (a substance with no active drug) to evaluate safety, how well it's tolerated, and how it affects and moves through the body.

Participant Groups

Group I: Single and Multiple Ascending Dose Experimental Treatment 1 Intervention

Ascending single doses and multiple doses for healthy volunteers.

Group II: Alzheimer's Disease Experimental Treatment 1 Intervention

Single Dose Open-label

Group III: Placebo Placebo Group 1 Intervention

Matching placebo

Who Is Running the Clinical Trial?

Vigil Neuroscience, Inc.

Lead Sponsor

Trials

3

Recruited

200+