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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-22

Study Completion Date

2025-01-10

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Alzheimer Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Single and Multiple Ascending Dose

Ascending single doses and multiple doses for healthy volunteers.

Group Type EXPERIMENTAL

VG-3927

Intervention Type DRUG

Dose Escalation

Placebo

Matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Dose Escalation

Alzheimer's Disease

Single Dose Open-label

Group Type EXPERIMENTAL

VG-3927

Intervention Type DRUG

One Dose Level

Interventions

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VG-3927

Dose Escalation

Intervention Type DRUG

Placebo

Dose Escalation

Intervention Type DRUG

VG-3927

One Dose Level

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes