160 Participants NeededMy employer runs this trial

AZD4916 for Healthy Volunteers

AC
Overseen ByAstraZeneca Clinical Study Information Center
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: AstraZeneca

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

I am not pregnant, not breastfeeding, and will use effective birth control.
I am Japanese, born in Japan, with all Japanese grandparents, and lived in Japan for most of my life.
I am healthy and have veins suitable for blood draws.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Single Ascending Dose (SAD)

Participants receive a single oral dose of AZD4916 or placebo

8 days

Multiple Ascending Dose (MAD)

Participants receive multiple doses of AZD4916 or placebo from Day 4 through Day 17

24 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

20 days

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

Group I: AZD4916Experimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials
4,491
Recruited
290,540,000+

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

Trials
322
Recruited
137,000+
Peyton Howell profile image

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 profile image

Dr. Austin Smith

Parexel

Chief Medical Officer since 2023

MD from the Royal College of Surgeons in Ireland

Citations

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