AZD4916 for Healthy Volunteers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called AZD4916 to evaluate its safety and tolerability. Researchers aim to understand how the body processes this experimental treatment. Participants will receive either AZD4916 or a placebo (a substance with no active drug) for comparison. The trial targets healthy adults with suitable veins for blood tests, with specific criteria for Japanese and Chinese participants. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Is there any evidence suggesting that AZD4916 is likely to be safe for humans?
Research has shown that AZD4916 is being tested for safety and tolerability in healthy volunteers. Specific information about side effects is not yet available, but ongoing studies closely monitor for any problems. As an early-stage study with healthy participants, the primary goal is to ensure the treatment's safety before further testing. While detailed safety information is still being collected, researchers are carefully observing the treatment for any issues.12345
Why do researchers think this study treatment might be promising?
AZD4916 is unique because it introduces a new active ingredient that targets the condition in a novel way. Unlike most treatments which might take weeks to show effectiveness, AZD4916 has the potential to show results quickly, possibly within days. Additionally, its administration method — a single or multiple oral doses — might offer greater convenience compared to more cumbersome or invasive treatments. Researchers are excited about AZD4916 because it might improve the speed and ease of treatment for patients.
What evidence suggests that AZD4916 could be effective?
AZD4916 remains in the early testing stages, so limited information exists about its efficacy. In this trial, participants will receive either AZD4916 or a placebo. The main goal is to understand the drug's absorption and processing in the body, known as pharmacokinetics. This study helps researchers determine the right doses and identify any possible side effects. Currently, the focus is on safety and understanding how the body handles the drug in healthy individuals. No specific evidence yet shows that AZD4916 effectively treats any particular condition.678910
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
Citations
1.
researchgate.net
researchgate.net/publication/44591067_Healthy_volunteers_and_early_phases_of_clinical_experimentation(PDF) Healthy volunteers and early phases of clinical ...
The present review discusses issues concerning the enrollment of healthy volunteers in the early phase of drug development from different points of view, with ...
2.
dev-multi-sponsor-trials.xogene.com
dev-multi-sponsor-trials.xogene.com/trials?conditions=Healthy%20Volunteers%20OnlyFind a Clinical Trial - GoodDay - Xogene
Healthy Volunteers Only. A Study to Assess the Safety and Effects of the Investigational Drug BW-40202 in Healthy Volunteers. Recruiting.
Comparison of Pharmacokinetic Responses to Three ...
The purpose of this study is to examine how the body absorbs, digests, and metabolizes three different investigational ketone dietary supplements (ketone ...
4.
trial.medpath.com
trial.medpath.com/clinical-trial/fa578118bfe458b1/nct00687232-randomised-placebo-controlled-study-azd4818-safetySafety, Tolerability and Pharmacokinetics... | Clinical Trial
The purpose is to investigate safety and tolerability of single and multiple ascending inhaled doses of AZD4818 in healthy Japanese male ...
NCT02268916 | Physical Activity and Participation
The investigators developed a lifestyle intervention based on individual's home activity patterns. The goal of the study is to test the efficacy of this ...
Safety, Tolerability, PK, and PD of TGM-148 in Healthy ...
A Study to Investigate the Safety and Pharmacokinetics of Single- and Multiple-ascending Doses of AZD4916 in Healthy Volunteers Recruiting. A ...
CEO blog: UK life sciences momentum, investment and ...
The payment was triggered by the clinical trial entry of AZD4916 ... safety data in healthy volunteers. In addition, Tangram announced ...
BMS-986446 - Clinical Trials in the USA - Priya Life Science
A Study to Investigate the Safety and Pharmacokinetics of Single- and Multiple-ascending Doses of AZD4916 in Healthy Volunteers Recruiting.
9.
linkedin.com
linkedin.com/posts/carolinecj_novartis-trem2-drug-fails-phase-2-als-trial-activity-7505959106545958914-LXA2Novartis Faces Clinical Pipeline Setbacks and Revenue ...
AZD4916 has entered a Phase I study in healthy volunteers → The program is being developed for inflammatory and respiratory diseases … igible ...
Phase 1 Study in Healthy Adults to See How Sevabertinib ...
A Study to Investigate the Safety and Pharmacokinetics of Single- and Multiple-ascending Doses of AZD4916 in Healthy Volunteers Recruiting. A ...
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