NCT06226064CompletedPhase 1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VES001 in Healthy Participants

A Randomised, Double-blind, Placebo-controlled Single and Multiple Ascending Dose Study in Healthy Volunteers and Asymptomatic GRN Mutation Carriers to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VES001

Source: ClinicalTrials.gov · Last updated 22 Aug 2024

Brief summary (registry, in English)

This is a Phase 1, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single and multiple doses of VES001 in a two part followed by a multicenter, open-label Phase 1b study in asymptomatic GRN mutation carriers. Part A will evaluate the safety, tolerability, PK, and PD of single doses of VES001 in healthy volunteers. Part B will evaluate the safety, tolerability, PK, and PD of multiple doses of VES001 in healthy volunteers.

Status (registry): Completed
Phase (registry): Phase 1
Study type: Interventional
Enrollment: 78 (actual)
First submitted: 7 Dec 2023
Start date: 11 Oct 2023
Primary completion date: 26 Jul 2024
Lead sponsor: Vesper Biotechnologies ApS
Diseases: Frontotemporal dementia
NCT number: NCT06226064

What you commit to

Study type: Interventional · Phase 1
Participants enrolled: 78
From 11 Oct 2023 to the primary completion date, 26 Jul 2024
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Recent medication or supplement use, unless allowed by the investigator.
Positive tests for illegal drugs or alcohol at screening.

Other illness

Medical conditions or treatments that could interfere with the study.
History of any known neurologic disease, cognitive impairment, or a history of seizure, (significant) head trauma, or loss of consciousness.
History of active malignancy (active cancer cells or tumors) within the last 5 years.
History of severe allergic reactions to medication

Lab values

Abnormal laboratory test results or infectious diseases (Hepatitis B, Hepatitis C, and/or HIV).

Other

Participation in other research studies involving study treatment or devices.
Heavy smoking or inability to abstain from smoking during the study.
Excessive consumption of caffeine (more than 8 cups per day).
Recent blood donation or significant blood loss.
Pregnancy, breastfeeding, or plans to become pregnant (for women).

Who the study is looking for

Healthy men or women aged 18 to 55 years.
Body Mass Index between 18 and 32 kg/m2, with a minimum weight of 50 kg.
Effective contraception required during the study and for at least 90 days after their last dose.
Participants in group 3, where the food effect is being investigated, must be able to eat a high-fat meal within 30 minutes for breakfast.

Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Center for Human Drug Research Coordinator of this site? Confirm its status	Leiden	Netherlands	Unknown status

Related publications

Preclinical and clinical investigation of VES001, an oral small molecule sortilin receptor inhibitor for the treatment of frontotemporal dementia: a first-in-human randomized placebo-controlled phase 1 trial.Nat Commun · 2026 · PMID 42875454

This page is information, not medical advice. Discuss any trial with your doctor.