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

Last updated: August 21, 2024
Sponsor: Vesper Biotechnologies ApS
Overall Status: Completed

Phase

1

Condition

Dementia

Memory Loss

Frontotemporal Dementia

Treatment

VES001

Placebo

Clinical Study ID

NCT06226064
Ph1/VES001
  • Ages 18-55
  • All Genders
  • Accepts Healthy Volunteers

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.

Eligibility Criteria

Inclusion

Inclusion Criteria Part A & B:

  1. Healthy men or women aged 18 to 55 years.

  2. Body Mass Index between 18 and 32 kg/m2, with a minimum weight of 50 kg.

  3. Effective contraception required during the study and for at least 90 days after their last dose.

  4. 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.

Exclusion Criteria Part A & B:

  1. Medical conditions or treatments that could interfere with the study.

  2. History of any known neurologic disease, cognitive impairment, or a history of seizure, (significant) head trauma, or loss of consciousness.

  3. History of active malignancy (active cancer cells or tumors) within the last 5 years.

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

  5. Recent medication or supplement use, unless allowed by the investigator.

  6. Participation in other research studies involving study treatment or devices.

  7. Positive tests for illegal drugs or alcohol at screening.

  8. Heavy smoking or inability to abstain from smoking during the study.

  9. Excessive consumption of caffeine (more than 8 cups per day).

  10. History of severe allergic reactions to medication

  11. Recent blood donation or significant blood loss.

  12. Pregnancy, breastfeeding, or plans to become pregnant (for women).

Study Design

Total Participants: 78
Treatment Group(s): 2
Primary Treatment: VES001
Phase: 1
Study Start date:
October 11, 2023
Estimated Completion Date:
July 26, 2024

Study Description

Part A will include six cohorts, with eight participants per cohort. Participants in each cohort will be randomised in a 6:2 ratio (VES001 vs. placebo).

Part B will include three cohorts, with ten participants per cohort. Participants in each cohort will be randomised in a 8:2 ratio (VES001 vs. placebo).

Connect with a study center

  • Center for Human Drug Research

    Leiden, 2333
    Netherlands

    Site Not Available

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