FIH SAD MAD Study of VS-041 (QSC302189)
Research type
Research Study
Full title
A Single and Multiple Dose-Escalation First-in-Human Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VS-041 in Healthy Subjects
IRAS ID
1010070
Contact name
Wieslaw Bochenek
Contact email
Sponsor organisation
Vasa Therapeutics Sp. z o. o.
ISRCTN Number
ISRCTN15814719
Research summary
The Sponsor is developing the test medicine, VS-041, as a potential treatment for heart failure with preserved ejection fraction (HFpEF). This is a condition where the heart has increased difficulty to pump blood resulting in typical symptoms such as breathlessness, ankle swelling and fatigue.
In this study, we’ll give healthy volunteers single or repeated doses of test medicine or dummy medicine (placebo), to assess the safety and tolerability of the test medicine, and how the body affects it. The effect of food will also be assessed. We’ll collect blood and urine samples to complete safety tests and measure the amount of test medicine.
The test medicine hasn’t been given to humans before. We’ll start with a low dose and test higher doses as the study progresses.
This study will take place at one non-NHS site in Nottingham and consists of two parts. We plan to enrol approximately 72 healthy men and women who are unable to have a baby, aged 18-55 years old.
SAD Cohorts 1, 2, 4 and 5: Each volunteer will receive a single dose of the test medicine or placebo, as tablets by mouth in the fasted state. Volunteers will stay in the clinic for up to 3 nights, attend 1 follow-up visit, receive 1 follow-up call and take approximately 6 weeks to finish the study.
SAD Cohort 3: Each volunteer will receive a single dose of the test medicine or placebo, as tablets by mouth in the fasted state in Period 1 and a singles dose of the test medicine in the fed state in Period 2. Volunteers will stay in the clinic for up to 3 nights and attend 1 follow-up visit in each period, receive 1 follow-up call and take approximately 12 weeks to finish the study.
MAD Cohorts: Volunteers will receive the test medicine or placebo once or twice daily for 7 days, as tablets by mouth in the fasted state. Volunteers will stay in the clinic for up to 9 nights, attend 1 follow-up visit, receive 1 follow-up call and take approximately 8 weeks to finish the study.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
24/LO/0437
Date of REC Opinion
27 Aug 2024
REC opinion
Further Information Favourable Opinion