Safety, PK and PD of BMS-986259 given in SAD and MAD in HV
Research type
Research Study
Full title
A Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BMS-986259 in Healthy Participants.
IRAS ID
271974
Contact name
Jorg Taubel
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2019-001266-15
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 6 days
Research summary
Heart failure is a significant global healthcare problem. It occurs when the heart can no longer pump enough blood around the body to meet its needs. It is currently estimated that 26 million patients worldwide suffer from heart failure and this number is increasing with an ageing population. In Western societies, heart failure is the most common reason for hospitalisation and the 5-year mortality is greater than that of many kinds of cancer (Brauwald 2015).
H2-relaxin is a type of hormone that is secreted primarily by the corpus luteum. It’s presence in the bloodstream is associated with the many of the physiological adaptations that occur during human pregnancy. These include increasing arterial elasticity, decreasing the resistance to blood flow throughout the body and increasing blood flow to and through the kidneys.
BMS-986259 has been shown to closely mimic the properties of H2-relaxin in in vitro studies as well as rodent models. As a result, BMS-986259 has the potential to help patients with heart failure in a significant way.
References:
Braunwald E. The war against heart failure: the Lancet lecture. Lancet. 2015 Feb 28;385(9970):812-24REC name
London - London Bridge Research Ethics Committee
REC reference
19/LO/1503
Date of REC Opinion
6 Nov 2019
REC opinion
Favourable Opinion