Phase 1 Study to Evaluate the Safety of mRNA-0184 in Participants with Heart Failure
Research type
Research Study
Full title
A Phase 1, Adaptive, Open-Label, Single Ascending Dose to Single-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of mRNA-0184 in Participants with Chronic Heart Failure
IRAS ID
1005671
Contact name
Rajish Saini
Contact email
Sponsor organisation
Moderna TX, Inc
Eudract number
2022-000784-46
ISRCTN Number
ISRCTN79552451
Research summary
Chronic heart failure (HF) is a condition commonly caused by an abnormality or damage to the heart muscle. Approximately 920,000 people in the UK have been diagnosed with HF. The goals of treatment are to improve the patient’s quality of life and reduce mortality.
mRNA-0184 is an investigational drug that is being studied to determine its ability to increase your body’s ability to make a protein like a naturally occurring hormone called relaxin, which promotes widening of blood vessels and the formation of new blood vessels.
This is a phase 1 first-in-human study to evaluate the safety and tolerability of single and multiple doses of mRNA-0184 in participants with chronic HF.
The study has a Single Ascending Dose (SAD) and a Multiple Ascending Dose (MAD) stage. Each stage will be split into several groups based on the dose of mRNA-0184 that will be given.
Participants in the SAD groups will receive one dose of mRNA-0184 and are expected to be in the study for up to 31 weeks.
Participants enrolled in the MAD groups will be assigned by chance in a 3:1 ratio to receive up to 4 doses of either mRNA-0184 or placebo (an inactive substance that looks like the study drug). Treatment will be administered at dosing intervals of once every 2, 3 or 4 weeks, depending on data from the SAD groups. The duration for participants in these groups is up to 46 weeks depending on the dose interval.
All participants will be closely monitored during study drug infusion and for a period after completion of the infusion. Study procedures include physical examinations, blood and urine samples, questionnaires, ECGs, ultrasounds of the heart and kidneys and monitoring of blood pressure and heart rate/rhythm.
Up to 98 patients will participate in the study across Europe and North America.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
22/SC/0208
Date of REC Opinion
7 Oct 2022
REC opinion
Further Information Favourable Opinion