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Study in Asymptomatic GRN-FTD Patients to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VES001

NCT06705192 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-08-24

No results posted yet for this study

Summary

This is an open-label, multiple dosing study in asymptomatic GRN-FTD carriers to investigate the safety, tolerability, PK, and PD of VES001. The study follows a MAD design within a single cohort, investigating 2 distinct dose levels (Dose 1: 360 mg and Dose 2: 900 mg), consecutively over a 3-month period. A total of 6 participants will be recruited over a fixed enrolment period of 6 months.

Conditions

  • Dementia
  • Frontotemporal Dementia
  • Asymptomatic Condition

Interventions

DRUG

VES001

VES001 is an oral, blood brain barrier ligand of sortilin. VES001 will be administered orally as a solid within a gelatine capsule without excipients; the capsule strength will be 180 mg.

Sponsors & Collaborators

  • Mads Kjolby

    lead INDUSTRY

Principal Investigators

  • Mads Kjoelby, MD, PhD · Vesper Bio

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-12
Primary Completion
2025-08-05
Completion
2025-08-05

Countries

  • Netherlands
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT06705192 on ClinicalTrials.gov