AZD4916 for Healthy Volunteers
What You Need to Know Before You Apply
What is the purpose of this trial?
The main purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) of AZD4916 in healthy adult participants.
Are You a Good Fit for This Trial?
This trial is for healthy adults with a BMI between 18 and 30, weighing at least 45 kg. Women must not be pregnant or breastfeeding and must use effective birth control. Some groups require Japanese or Chinese ancestry and limited time living outside their country of origin.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Single Ascending Dose (SAD)
Participants receive a single oral dose of AZD4916 or placebo
Multiple Ascending Dose (MAD)
Participants receive multiple doses of AZD4916 or placebo from Day 4 through Day 17
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- AZD4916
Trial Overview
The study tests different single and multiple doses of AZD4916 compared to a placebo in healthy volunteers to see how safe the drug is and how it moves through the body.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Parts 1a and 2a participants will receive a single oral dose of AZD4916 on Day 1. Parts 1b and 2b participants will receive a single oral dose of AZD4916 on Day 1 and multiple doses of AZD4916 on Days 4 through 17.
Parts 1a and 2a participants will receive a single oral dose of placebo on Day 1. Parts 1b and 2b participants will receive a single dose placebo on Day 1 and multiple doses of placebo on Days 4 through 17.
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
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