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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Wieslaw
Bochenek
(+1) 267 218 5021
wbochenek@vasatherapeutics.com
Dr
Philip
Evans
+44 (0)330 3031000
recruitment@weneedyou.co.uk
Heart failure with preserved ejection fraction (HFpEF)
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Female study subject who is pregnant or breastfeeding.2. Any clinically significant disease, active malignancy or history of malignancy (excluding basal cell carcinoma) or disorder (eg, cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal fractures, endocrine including adrenal insufficiency, metabolic, psychiatric, major physical impairment) which, in the opinion of the PI, may either put the subject at risk because of participation in the study, or influence the result of the study, or the subject's ability to participate in the study.3. Any physical or psychological condition which, in the opinion of the PI, would compromise the subject's safety or successful participation in this trial.4. Subjects with a known hypersensitivity to VS-041 or any of the excipients (mannitol, croscarmellose sodium, silica colloidal anhydrous [Aerosil], sodium dodecyl sulfate, sodium stearyl fumarate) of the product.5. Current evidence of COVID-19 infection as determined by the PI (following local practice) or hospitalized with COVID-19 infection within the last 3 months prior to Screening.6. History of drug or alcohol abuse or addiction within 2 years before the start of study medication dosing. 7. Positive test results for alcohol at Screening or admission.8. Positive drugs of abuse testing at Screening or admission for the drugs listed in the protocol SoA.9. Use of any medications except for the medications exempted by the PI on a case-by-case basis after they are judged to be unlikely to affect the PK profile of the study medication or subject safety (eg, topical drug products without significant systemic absorption, simple pain killers [eg, acetaminophen/paracetamol up to 2g/24hour]): 9.1. Prescription medications within 14 days prior to the first dosing until follow-up visit9.2. Over-the-counter products and natural health products (including herbal remedies, homeopathic and traditional medicines, probiotics, food supplements such as vitamins, minerals, amino acids, essential fatty acids, and protein supplements used in sports) within 14 days prior to the first dosing (except for the occasional use of acetaminophen/ paracetamol [up to 2 g daily]) until follow-up visit9.3. Depot injection or implant of any drug within 3 months prior to the first dosing until follow-up visit10. Subject has an uncontrolled or serious disease, or any medical or surgical condition, deemed by the PI to be likely to interfere with the participation in the clinical study and/or put the subject at significant risk and or to compromise the interpretation of trial results if she/he participates in the clinical study.11. Any laboratory values with the following deviations at the Screening; test may be repeated at the discretion of the PI, if abnormal:11.1. Any positive result on Screening for serum hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) antibody 11.2. Alanine transaminase (ALT) > 1.1 x upper limit of normal (ULN)11.3. Aspartate aminotransferase (AST) > 1.1 x ULN11.4. Total bilirubin (TBL) > ULN11.5. Platelet count ≤ lower limit of normal (LLN)11.6. CPK > 2 x ULN12. Abnormal resting vital signs (after resting supine for 5 minutes) of blood pressure (BP), systolic > 140 mmHg or < 100 mmHg or diastolic > 90 mmHg or < 40 mmHg and heart rate (HR) <50 and >90 bpm.13. Study subjects have clinically significant ECG abnormality at Screening, in the opinion of the PI. In addition, any study subject with any of the following findings will be excluded:13.1. Mean QT corrected for HR using Fridericia’s formula (QTcF) interval >450 msec for males and females based on the mean of triplicate ECG tracings.13.2. Bundle branch blocks (complete bundle branch block with, marked right or left axis deviation or second- and third-degree atrioventricular block are excluded). Mild first-degree atrioventricular block (defined as PR interval ≤ 230 ms), incomplete right bundle branch block (QRS ≤ 120 ms) or left anterior hemiblock are acceptable if no underlying disease is suspected by the PI. Entry of any subject with an abnormal but not clinically significant ECG must be approved and documented by signature of the PI or medically qualified sub investigator.13.3. Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular or rare ventricular ectopic beats13.4. T-wave configurations not of sufficient quality for assessing QT interval duration14. Subject with a history of recurrent unexplained syncope or a family history of sudden death due to long QT syndrome.15. Significant blood loss or has donated or received 1 or more units (450 mL) of blood within 3 months prior Screening or has donated plasma or platelets within 14 days prior to baseline admission.16. Vulnerable subject (eg, subjects kept in detention, military, police, adults with legally authorised representative), employees of the Sponsor or the Contract Research Organisation (CRO) with direct involvement in the proposed study or other studies under the direction of the PI or the CRO, as well as family members of the employees of the Sponsor, CRO, or the PI.17. Study subjects received an investigational medicinal product or participated in another study within a period 90 days before admission.18. Received prior treatment with an investigational medical device or participated in a study of an investigational medical device within a period of 90 days before admission.19. Plans to participate in another medicinal product study or device under investigation during this study period.20. Any other reason which, in the opinion of the PI, would prevent the subject from participating in the study.21. Any evidence of a condition, which in the PI's opinion, makes it undesirable for the subject to participate in the study.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Dr
Wieslaw
Bochenek
(+1) 267 218 5021
wbochenek@vasatherapeutics.com
Dr
Philip
Evans
+44 (0)330 3031000
recruitment@weneedyou.co.uk
The study is sponsored by Vasa Therapeutics Sp. z o. o. and funded by Vasa Therapeutics Sp. z o. o..
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
