AZD5148 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 medicine, AZD5148, administered as a single injection. The study involves healthy volunteers and aims to observe how the body processes the drug, delivered either as a quick intravenous (IV) shot or an intramuscular (IM) shot. Different groups participate, with some receiving the actual drug and others a placebo (a harmless, inactive substance). Participants must be healthy, without significant illnesses, and have suitable veins for blood samples. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new medicine.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy participants, it's possible that taking medications could affect eligibility.
Is there any evidence suggesting that AZD5148 is likely to be safe for humans?
Research has shown that AZD5148 has been tested for safety in healthy individuals using both intravenous (IV) and intramuscular (IM) methods. Studies have found that AZD5148 is generally well-tolerated, with no significant reports of serious side effects from a single dose. This suggests the treatment could be safe for trial participants. As a Phase 1 trial, the primary goal is to assess the safety of AZD5148, which is why it is tested on healthy volunteers. While more information is needed for a complete safety profile, early results from similar studies are promising.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about AZD5148 because it could offer a new approach to treating conditions that currently rely on traditional drug therapies. Unlike existing treatments that typically involve oral or long-term medication, AZD5148 is administered either as an intramuscular injection or an intravenous bolus, which could potentially provide faster and more targeted effects. This treatment is also being explored for different doses and delivery methods, which could help customize therapy for a broader range of patients. If successful, AZD5148 might offer a more efficient and adaptable option compared to current standards of care.
What evidence suggests that AZD5148 could be effective?
Research shows that AZD5148 has potential because it can neutralize a wide range of conditions in lab tests. The component of AZD5148 that attaches to its target has remained unchanged over the years, suggesting it could consistently reach the right area. So far, studies have mainly focused on its safety and tolerability. These early results are promising for its future effectiveness. As more information becomes available, researchers will better understand its efficacy.12367
Are You a Good Fit for This Trial?
Healthy adults with good veins for blood draws can join. Women must not be pregnant, and if they can have children, they need to use birth control. People of Chinese descent must meet specific ancestry criteria. You can't join if you've had a serious illness or surgery recently, any history of cancer (except certain skin/cervical cancers), immune problems including HIV, drug/alcohol abuse, bleeding disorders, are detained or under legal supervision.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of AZD5148 or placebo via IM injection or IV bolus
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD5148
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