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

NCT06226064 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2024-08-22

No results posted yet for this study

Summary

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.

Conditions

  • Dementia, Frontotemporal

Interventions

DRUG

VES001

VES001 is an oral, blood brain barrier penetrating ligand of sortilin.

DRUG

Placebo

A matching dosage form, indistinguishable from the active treatment will be used as the placebo treatment.

Sponsors & Collaborators

  • Vesper Biotechnologies ApS

    lead INDUSTRY

Principal Investigators

  • Mads Kjolby, MD, PhD · Vesper Bio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-10-11
Primary Completion
2024-07-26
Completion
2024-07-26

Countries

  • Netherlands

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06226064 on ClinicalTrials.gov