A SAD, MAD, safety, PK and PD study of AZD5718 in healthy subjects
Research type
Research Study
Full title
A phase 1, randomized, single-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AZD5718 after single and multiple ascending dose administration to healthy male subjects
IRAS ID
195214
Contact name
John Lambert
Contact email
Sponsor organisation
AstraZeneca
Eudract number
2015-004676-30
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 20 days
Research summary
Before a new medicine can be approved for use in humans, it is necessary to confirm that it is safe and effective. This is done by carrying out research studies (or clinical studies) such as this one.\n\nThe new medicine tested in this study is a compound called AZD5718(referred to as the “study drug”). The Sponsor AstraZeneca AB is developing the study drug for treating heart disease.\n\nThe main purpose of the study is to see how safe and tolerable the study drug (AZD5718) is after single (Part A) and multple increasing doses (Part B). Another aim is to determine the maximum tolerated dose of AZD571.\n\nThis study will recruit healthy, non-smoking males between the ages of 18 and 50 years (inclusive). A total of 136 subjects will take part in the study. This is the first time the study drug will be given to humans.\n\nVital signs, safety electrocardiogram (ECG) measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
15/SC/0719
Date of REC Opinion
18 Jan 2016
REC opinion
Further Information Favourable Opinion