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

Vigil Neuroscience

Status and phase: Completed; Phase 1

Conditions: Alzheimer Disease; Healthy

Treatments: Drug: VG-3927; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06343636

VG3927-02.101

Details and patient eligibility

About

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.

Enrollment: 115 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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115 participants in 3 patient groups, including a placebo group

Single and Multiple Ascending Dose

Experimental group

Description:

Ascending single doses and multiple doses for healthy volunteers.

Treatment:

Drug: VG-3927

Drug: VG-3927

Placebo

Placebo Comparator group

Description:

Matching placebo

Treatment:

Drug: Placebo

Alzheimer's Disease

Experimental group

Description:

Single Dose Open-label

Treatment:

Drug: VG-3927

Drug: VG-3927