INS-3001 in participants with moderate aortic valve stenosis
Research type
Research Study
Full title
A FIRST-IN-HUMAN, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, SINGLE AND MULTIPLE ASCENDING DOSE STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF INS-3001 IN HEALTHY SUBJECTS AND PATIENTS WITH MODERATE AORTIC VALVE STENOSIS
IRAS ID
1004538
Contact name
David Newby
Contact email
Sponsor organisation
Inositec AG
Eudract number
2021-001969-20
ISRCTN Number
ISRCTN76722400
Research summary
This is a first-in-human study to see if a test medicine not yet approved for market, named INS-3001, will help in the treatment of cardiovascular calcifications (calcium deposits in the heart and/or arteries). Such calcification in the aortic valve results in aortic valve stenosis. Aortic valve stenosis is a narrowing of the aortic valve that makes it harder for blood to flow from the heart to the aorta. \n\nParticipants will receive the study medication, INS-3001 or placebo, as an injection under the skin once a day for approximately 14 days. Doses will increase based on the data gathered during the trial, including how safe and tolerable the medication is. We will also assess the concentrations of the medication in the blood and how well it binds to the aortic valve. Participants may have up to 2 overnight stays at the study site during the period they are receiving study medication.
REC name
North East - York Research Ethics Committee
REC reference
22/NE/0004
Date of REC Opinion
8 Feb 2022
REC opinion
Further Information Favourable Opinion