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?

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

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.
See 3 more

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