Not yet recruitingPHASE1INTERVENTIONAL

A Study to Investigate the Safety and Pharmacokinetics of Single- and Multiple-ascending Doses of AZD4916 in Healthy Volunteers

This study is investigating a new medication called AZD4916. The main aim is to understand if it's safe for people and how their bodies handle it. Researchers will give healthy volunteers either AZD4916 or a dummy pill (placebo) in carefully controlled doses. Some participants will receive a single dose, while others will take multiple doses over time. The study will also look specifically at how people of Japanese and Chinese descent respond to the medication. This early-stage research is important for gathering basic information on how a new medicine works before it can be tested in patients with specific conditions.

At a glance

Status

Not yet recruiting

Phase

PHASE1

Sponsor

AstraZeneca

Enrolment target

178

Start

27 Jun 2025

Estimated completion

24 Sep 2026

Healthy Participants

What is this study about?

This study is an early-stage clinical trial looking into a new medication called AZD4916. Its main purpose is to see if this new medicine is safe for people to take and to understand how it behaves in the human body. This includes how it's absorbed, distributed, broken down, and removed from the body. Scientists call this 'pharmacokinetics'. By understanding these things, they can figure out the right doses for future studies.

Participants in this study will be healthy adults. Some will receive AZD4916, and others will receive a 'placebo', which looks like the study drug but contains no active medicine. This helps researchers fairly compare the effects of the new drug. Some people will take a single dose, while others will take multiple doses over a period of time. A specific part of the study will also look at how Japanese and Chinese individuals react to the medicine, as responses can sometimes differ between different ethnic groups.

This kind of study is really important because it's the first step in developing new medicines. It helps researchers gather crucial information about a drug's safety and how it works before it can be tested in people who might benefit from it for a particular illness. No medical recommendations about AZD4916 are being made, as this is purely an exploratory safety study.

Key takeaways

This is a very early study of a new medicine called AZD4916 in healthy volunteers.
The main goals are to check the drug's safety and how it moves through the body.
You might receive the new drug or a dummy pill (placebo).
Participation involves health checks and close monitoring at a clinic.
Specific parts of the study will involve people of Japanese and Chinese background.
Your health will be carefully watched, and you can leave the study at any time.

Who may be eligible?

To join this study, you need to be a healthy adult between 18 and 55 years old and weigh at least 45 kg. Your body mass index (BMI) should be between 18 and 30. You also need to have veins that can be used for taking blood samples or for drips easily.

If you are a woman of childbearing age, you must not be pregnant or breastfeeding, and you must agree to use effective contraception during the study. The study cannot accept anyone who has a significant medical condition, history of serious illness, severe allergies, or problems with their stomach, liver, or kidneys.

You also can't take part if you have certain infections like HIV or hepatitis, or if you smoke, use recreational drugs, or drink excessive alcohol or caffeine. There are also specific requirements for participants of Japanese or Chinese descent invited to a particular part of the study, relating to their birth country and family background.

Quick self-check

Are you between 18 and 55 years old?
Do you weigh at least 45 kg and have a healthy BMI (18-30)?
Are you generally healthy with no major long-term illnesses?
If you are a woman of childbearing age, are you not pregnant or breastfeeding, and willing to use effective contraception?
Do you not smoke, use recreational drugs, or drink excessive alcohol/caffeine habitually?
Do you live in the UK and meet the general health requirements?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you take part in this study, you will first go through a screening process to check if you are eligible based on the criteria mentioned. This will involve physical exams, blood tests, and other health checks.

If you are accepted, you will receive either the study drug, AZD4916, or a placebo (a dummy pill). You might receive a single dose or multiple doses over time. The study visits will take place at a single research clinic. You may need to stay at the clinic for periods of time after receiving the study drug for monitoring, and attend follow-up appointments.

Throughout the study, the research team will closely monitor your health using blood tests, urine tests, and other examinations to check for any side effects and to see how your body is responding to the medication. The exact number of visits and the duration of your stay at the clinic will depend on whether you are in the single-dose or multiple-dose part of the study.

Potential risks and benefits

Taking part in a study like this might not directly benefit your health, as it's designed to gather information about a new drug rather than treat an illness. However, you would be helping researchers learn more about new medicines, which could help others in the future. As with any medication, there's a chance of experiencing side effects, some of which may be unexpected. The research team will watch you very closely for any problems. You are entirely free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Research Site
Harrow, United Kingdom

Common questions

What is AZD4916 for?

At this early stage, researchers are just trying to understand how AZD4916 works in healthy people and if it's safe. It's not yet known what specific conditions it might treat in the future.

Will I know if I'm getting the real drug or a dummy pill?

No, this is a 'single-blind' study, meaning you won't know if you're receiving AZD4916 or the placebo. This helps ensure fair results.

How long will I be involved in the study?

The overall length of your involvement will depend on which part of the study you are in, specifically whether you receive a single dose or multiple doses. The research team will explain this fully.

Will I get paid for taking part?

The study information doesn't specify payment, but many clinical trials offer compensation for your time and travel. This is a good question to ask the research team directly.

What if I feel unwell during the study?

The research team will be monitoring you closely. If you feel unwell at any point, you must tell them immediately so they can provide care and assess if it's related to the study drug.

How to find out more

AstraZeneca Clinical Study Information Center

information.center@astrazeneca.com 1-877-240-9479 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.