AZD4954 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the safety and tolerability of a new drug, AZD4954, in healthy individuals. It aims to understand the drug's behavior and effects in the body with single or multiple doses. The study is open to healthy individuals with normal plasminogen levels, and part of the trial requires participants with elevated Lipoprotein(a) levels, a type of protein in the blood. Participants should not have significant health issues that might affect drug absorption or processing. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I have to stop taking my current medications for the trial?
The trial information does not specify if you need to stop taking your current medications. However, you should avoid drugs with enzyme-inducing properties, like St John's Wort, within 3 weeks before starting the study.
Is there any evidence suggesting that AZD4954 is likely to be safe for humans?
Research has shown that AZD4954 is being tested for safety and tolerability. This study is in the first phase, focusing on determining the treatment's safety for humans and identifying potential side effects.
Participants in studies like this might experience side effects, though the specifics are not always known. In a Phase 1 study, researchers closely monitor any side effects to ensure they remain manageable. The treatment is administered in varying doses to observe the body's reactions, helping researchers assess any risks.
If AZD4954 proves safe at this stage, it may proceed to further testing. This would indicate it is generally well-tolerated, but it is important to remember that findings from this early phase are just the beginning of understanding a new treatment's safety.12345Why do researchers think this study treatment might be promising?
Researchers are excited about AZD4954 because it offers a potentially novel approach by targeting pathways not addressed by current treatments. Unlike standard treatments, which may include therapies like beta-blockers or ACE inhibitors for cardiovascular conditions, AZD4954 might work through a unique mechanism of action. This uniqueness could lead to more effective management of the condition, possibly with fewer side effects or a faster onset of action. Moreover, its potential variability in dosing and the effect of food on its absorption are being explored, which could optimize its use in different patient populations.
What evidence suggests that AZD4954 could be effective for elevated Lipoprotein(a) levels?
Research has shown that AZD4954 might help lower Lipoprotein(a), a type of cholesterol linked to heart disease. Animal studies found that this drug effectively reduces these cholesterol levels by affecting certain processes in the body that control cholesterol production. Early results from healthy volunteers suggest that AZD4954 is safe and may lower Lipoprotein(a) in people. However, more research is needed to confirm these effects in a larger group. Participants in this trial will receive different doses of AZD4954 or a placebo to further evaluate its safety and efficacy.12367
Are You a Good Fit for This Trial?
This trial is for healthy adults, some with high levels of a cholesterol particle called Lipoprotein(a) or Lp(a). Participants should not have any significant health issues and must meet specific criteria set by the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment (Part A - SAD)
Participants receive a single dose of AZD4954 or placebo and are monitored for 15 days
Follow-up (Part A - SAD)
Participants are monitored for safety and effectiveness after treatment
Treatment (Part B - MAD)
Participants receive multiple doses of AZD4954 or placebo for 21 days (14 days for Japanese cohorts)
Follow-up (Part B - MAD)
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD4954
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology