AZD1163 Safety and Tolerability 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 treatment called AZD1163 in healthy participants. The study examines both intravenous (IV, through the vein) and subcutaneous (SC, under the skin) methods. Some participants will receive the actual treatment, while others will receive a placebo (a substance with no medical effect). It suits healthy individuals with no significant medical history and suitable veins for tests. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the unique opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that AZD1163, administered intravenously (IV) or subcutaneously (SC), is being tested for safety and tolerability in healthy individuals. AZD1163 is a new antibody drug that blocks certain enzymes linked to diseases like rheumatoid arthritis.
Early results suggest that administering AZD1163 every two weeks is generally well tolerated, with most participants not experiencing serious side effects. However, as this study is in its early stages, the primary goal is to assess the safety of AZD1163. While initial signs are positive, further research is necessary to fully confirm its safety.12345Why do researchers think this study treatment might be promising?
Researchers are excited about AZD1163 because it introduces a novel mechanism of action compared to current treatments for its target condition. Unlike the standard of care, which often involves oral medications, AZD1163 is delivered through intravenous (IV) and subcutaneous (SC) methods, potentially allowing for more precise dosing and targeted delivery. This could lead to improved safety and tolerability, particularly for individuals who may have difficulty with traditional oral medications. Additionally, the treatment's unique delivery methods might provide faster onset of action, which is a promising development for patients seeking quicker relief.
What evidence suggests that AZD1163 could be effective?
Research has shown that AZD1163 is a new drug targeting specific enzymes, PAD 2 and 4, involved in some autoimmune diseases. These enzymes contribute to the production of harmful proteins. Early studies indicate that AZD1163 effectively blocks these enzymes. Animal tests demonstrated that the body can safely process the drug. Initial human tests revealed that AZD1163 was well tolerated and did not cause major side effects. This trial will further evaluate the safety and tolerability of AZD1163 in healthy subjects, with participants receiving either AZD1163 or a placebo. This suggests potential benefits for conditions related to these enzymes, although more research is needed to confirm this.12346
Are You a Good Fit for This Trial?
Healthy adults with suitable veins for IV use, a BMI of 18-32 kg/m^2, and weighing at least 45 kg can join. Women must test negative for pregnancy and not be breastfeeding; sexually active women need effective contraception. Exclusions include recent drug trials, cancer history (except certain types), abnormal lab results, infectious diseases like hepatitis or HIV, heart ECG issues, significant health risks as per study criteria, recent serious infections or fever, substance abuse history, severe allergies.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1 (SAD)
Participants receive a single ascending dose of AZD1163 with an in-clinic period of 7 to 8 days
Treatment Part 2 (MAD)
Participants receive multiple ascending doses of AZD1163, given 2 weeks apart, each with an in-clinic period of 7 to 8 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD1163
- Placebo
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
Parexel
Industry Sponsor
Peyton Howell
Parexel
Chief Executive Officer
Master of Healthcare Administration from The Ohio State University, Bachelor of Arts in Health Communications from the University of Illinois
Dr. Austin Smith
Parexel
Chief Medical Officer since 2023
MD from the Royal College of Surgeons in Ireland