Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A placebo-controlled safety and tolerability study of intravenous (IV) and subcutaneous (SC) AZD1163 in healthy volunteers

This early-stage medical study, called a Phase I trial, is looking at a new medicine known as AZD1163. While the medicine is being developed for a condition called rheumatoid arthritis, this particular study involves healthy volunteers, not patients with the condition. The main goal is to check how safe the medicine is and if people can tolerate it well. Researchers will give the medicine in two ways: directly into a vein (intravenously) or as an injection under the skin (subcutaneously). This is one of the very first times this medicine will be given to humans, which is why it's carefully monitored to ensure participant safety and gather initial information about its effects.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

AstraZeneca AB

Enrolment target

Start

04 Apr 2024

Rheumatoid Arthritis

What is this study about?

This study is an important first step in developing a new medicine, called AZD1163, which is hoped to help people with rheumatoid arthritis. Rheumatoid arthritis is a long-term condition that causes pain, swelling, and stiffness in the joints.

The main purpose of this study is to find out if AZD1163 is safe for people and how well their bodies cope with it. Because it's a very new medicine, it's being tested in healthy volunteers first, rather than people who already have rheumatoid arthritis. This allows researchers to understand the medicine's basic effects without the complications of an existing illness. Researchers are also comparing two different ways of giving the medicine: directly into a vein (like a drip) or as an injection under the skin (like an insulin shot).

By carefully studying how healthy people react to AZD1163, doctors can learn vital information about potential side effects and how the body handles the medicine. This information is crucial before the medicine can be tested in people who actually have rheumatoid arthritis. It’s all about making sure that any new treatment is as safe and effective as possible when it eventually reaches patients.

Key takeaways

This is an early study (Phase I) of a new medicine, AZD1163, for rheumatoid arthritis.
The study involves healthy volunteers, not people with rheumatoid arthritis.
The main goal is to check how safe the medicine is and if people tolerate it well.
The medicine will be given either into a vein or as an injection under the skin.
You might receive the active medicine or a placebo (inactive substance).

Who may be eligible?

To join this study, you need to be an adult. Specifically, you must be 18 years old or older. The study is open to both men and women.

Since this is a very early study looking at safety in healthy people, you would not be able to join if you have certain health conditions that could interfere with the study results or put you at risk. For example, if you have rheumatoid arthritis yourself, or other serious long-term illnesses, this study would likely not be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Are you generally in good health?
Are you able to attend several clinic visits?
Are you comfortable with injections or IV drips and blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the study medicine, AZD1163, either through a drip into your vein or as an injection under your skin. You would also receive a placebo, which looks like the study medicine but contains no active ingredients. This helps researchers understand the true effects of the medicine.

You would need to attend several visits to a clinic over a set period. During these visits, doctors and nurses would perform various checks. This might include blood tests, checking your blood pressure and heart rate, and asking you how you are feeling. The exact number of visits and the total duration aren't specified here, but you would be given a detailed schedule if you considered joining. There would also be follow-up appointments after you stop taking the medicine to make sure you are well.

Potential risks and benefits

Taking part in a study like this involves some potential benefits and risks. There's no direct personal health benefit for you, as you are a healthy volunteer. However, you would be contributing valuable information that could lead to a new treatment for rheumatoid arthritis, helping many in the future. Potential risks could include side effects from the experimental medicine, discomfort from injections or blood tests, and the inconvenience of study visits. All possible risks would be fully explained before you agree to take part. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is rheumatoid arthritis?

Rheumatoid arthritis is a condition where your body's immune system mistakenly attacks your own joint tissues, leading to pain, swelling, and stiffness, mainly in the hands and feet.

Why is this medicine being tested in healthy people first?

Testing in healthy volunteers helps researchers understand the basic safety of the medicine and how it behaves in the body without the complications of an existing illness, before giving it to patients with the condition.

What is a 'placebo'?

A placebo is a substance or treatment that looks exactly like the real medicine but has no active ingredients. It's used to compare the effects of the actual medicine against no active treatment.

Will I know if I'm getting the real medicine or the placebo?

Usually, in this type of study, neither you nor the study team will know if you are receiving the active medicine or the placebo. This is called 'blinding' and helps ensure unbiased results.

What does Phase I mean?

Phase I is the very first stage of testing a new medicine in humans. It focuses mainly on safety, finding a safe dose, and understanding how the medicine is processed by the body.