NCT06343636

Brief Summary

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
115

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Sep 2023

Longer than P75 for phase_1 healthy

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 22, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 2, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

1.3 years

First QC Date

March 26, 2024

Last Update Submit

February 6, 2025

Conditions

HealthyAlzheimer Disease

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    To evaluate the safety and tolerability of VG-3927

    28 days post last dose

Study Arms (3)

Single and Multiple Ascending Dose

EXPERIMENTAL

Ascending single doses and multiple doses for healthy volunteers.

Drug: VG-3927

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: Placebo

Alzheimer's Disease

EXPERIMENTAL

Single Dose Open-label

Drug: VG-3927

Interventions

PlaceboDRUG

Dose Escalation

Placebo
VG-3927DRUG

Dose Escalation

Single and Multiple Ascending Dose

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

K2 Medical Research

Maitland, Florida, 32751, United States

Location

Clinical Pharmacology of Miami

Miami, Florida, 33014, United States

Location

Nucleus Network

Melbourne, Australia

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2024

First Posted

April 2, 2024

Study Start

September 22, 2023

Primary Completion

January 10, 2025

Study Completion

January 10, 2025

Last Updated

February 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)US(2)