AZD1613 for Healthy Subjects
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to assess the safety and tolerability of AZD1613, an experimental treatment, in healthy individuals, including those of Japanese and Chinese descent. It will also examine how the body processes the drug (pharmacokinetics) and how the drug affects the body (pharmacodynamics). Participants will receive either a single or multiple doses of AZD1613 through injection or infusion. Ideal candidates for this trial are healthy individuals with no significant medical history or ongoing conditions. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Will I have to stop taking my current medications?
Yes, you will need to stop taking most medications, including prescribed and non-prescribed ones, two weeks before the trial starts. This includes things like antacids, pain relievers (except paracetamol/acetaminophen), and herbal remedies.
Is there any evidence suggesting that AZD1613 is likely to be safe for humans?
Research is testing how well AZD1613 is tolerated by healthy individuals, including those of Japanese and Chinese descent. The study examines both single and multiple doses of AZD1613, administered either as a shot under the skin or through an IV drip.
As a Phase 1 trial, the main focus is on safety. Early trials like this aim to determine if a treatment is safe for humans. Specific information on AZD1613's tolerance is limited, but being in a Phase 1 trial suggests that serious side effects are not expected to be common. If the treatment caused major issues, it likely wouldn't continue in clinical testing.
Participants in this study help researchers learn more about the safety of AZD1613 and any side effects it might cause. This information is essential before testing the treatment in larger groups or for specific conditions.12345Why do researchers think this study treatment might be promising?
AZD1613 is unique because it explores multiple delivery methods, including both subcutaneous (SC) injections and intravenous (IV) infusions, which can provide flexibility in treatment administration. This diversity in delivery options could potentially make it more convenient for patients compared to existing treatments that might only offer one method. Researchers are excited about AZD1613 because it may offer a new mechanism of action or active ingredient that could enhance treatment effectiveness for certain conditions. This trial aims to understand the safety and dosing parameters better, potentially paving the way for more personalized and effective treatment strategies.
What evidence suggests that this trial's treatments could be effective?
Researchers are studying AZD1613 to assess its safety and how the body processes it. In this trial, participants receive varying doses of AZD1613, either as a single dose or multiple doses, through subcutaneous injection or intravenous infusion. Currently, there is no specific information on its effectiveness for any condition, as it is being tested in healthy individuals. The primary goal is to understand the body's tolerance, absorption, and breakdown of the treatment. Researchers are concentrating on safety and potential side effects. If AZD1613 proves well-tolerated, future tests may explore its use in treating diseases.12356
Are You a Good Fit for This Trial?
This trial is for healthy adults with good veins for blood draws, not pregnant or able to become pregnant. Men must use contraception. Participants need a BMI of 18-32 and weigh at least 50 kg. Specific parts of the study require participants to be of Chinese or Japanese descent, with both parents and all grandparents being from the same descent.Inclusion 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 subcutaneous (SC) or intravenous (IV) dose of AZD1613 or placebo
Follow-up (Part A - SAD)
Participants are monitored for safety and effectiveness after treatment
Treatment (Part B - MAD)
Participants receive multiple doses of AZD1613 or placebo at 28-day intervals
Follow-up (Part B - MAD)
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD1613
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