RecruitingPHASE1INTERVENTIONAL

Comparing the Extent to Which Romosozumab (AMG 785) is Made Available in the Body When Administered as a Single SC Injection or as 2 SC Injections

This study is investigating a new medicine called Romosozumab. It's designed to understand how this medicine is absorbed and used by the body. Specifically, we want to compare whether giving the full dose as one injection under the skin works the same way as giving it as two slightly smaller injections in two different spots. This helps researchers figure out the best and most effective way to give the medicine once it's available. We're looking for healthy volunteers aged between 18 and 60 years old to take part. This is an early stage study, meaning it's one of the first times this medicine is being tested in people to understand how it behaves.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Amgen

Enrolment target

308

Start

22 Sep 2026

Estimated completion

14 Jan 2027

Healthy Participants

What is this study about?

This study is an early-stage clinical trial looking into a medicine called Romosozumab. When a new medicine is developed, scientists need to understand how the body uses it. This particular study focuses on how much of the medicine gets into your system and how quickly it does so, depending on how it's given.

The main aim is to compare two ways of giving the medicine: either as a single injection under the skin, or as two smaller injections in two separate places. Imagine you have a certain amount of liquid medicine. This study wants to know if giving it all at once in one spot works the same as splitting it into two half-doses and giving them in two spots. This helps the researchers find the most efficient and comfortable way for patients to receive the medicine in the future.

Taking part in studies like this is really important for developing new medicines. By understanding how the body handles different ways of giving Romosozumab, we can help ensure that when this medicine is used to treat conditions in the future, it's given in the safest and most effective way possible.

Key takeaways

This study is testing a new medicine called Romosozumab in healthy adults.
It compares giving the medicine as one injection versus two smaller injections.
Your contribution helps scientists find the best way to give the medicine in the future.
You'll need to attend several clinic visits for health checks and blood tests.
You can stop participating at any time you wish.

Who may be eligible?

To join this study, you need to be a healthy adult, male or female, aged between 18 and 60 years old, and weigh between 45kg and 95kg. It's important that you're willing to follow all the study instructions and take daily calcium and vitamin D supplements throughout the study.

For women, you must not be able to become pregnant (for example, if you've gone through menopause or had certain medical procedures). Men who can father a child must agree to use reliable contraception during the study and for three months afterwards.

There are also some reasons you wouldn't be able to join. For instance, if you have any serious ongoing medical conditions, particularly heart problems, or if you've had a blood clot (like DVT or pulmonary embolism) in the last three months. The study doctors will carefully check your overall health, including your heart, blood pressure, and certain blood tests, to make sure it's safe for you to take part.

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 between 18 and 60 years old?
Do you weigh between 45kg and 95kg?
Are you generally healthy with no serious medical conditions?
Can you commit to taking daily calcium and vitamin D supplements?
For women: Can you not become pregnant? For men: Are you willing to use contraception during and after the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit to check if you're suitable for the study based on your health and medical history. This will involve a physical check-up, blood tests, and an ECG (a check of your heart's electrical activity).

If you qualify, you'll receive the study medicine, Romosozumab, as an injection under the skin. Depending on which group you're in, this will either be a single injection or two smaller injections given at the same time. You will be asked to take daily calcium and vitamin D supplements.

The study involves several visits to the clinic, which will include further check-ups, blood tests to see how the medicine is being handled by your body, and possibly more ECGs. The total length of your involvement in the study will be explained to you, along with how many visits you'll need to attend and what each visit will involve.

Potential risks and benefits

Taking part in any research study has potential benefits and risks. For this particular study, a potential benefit is contributing to medical science and helping develop the best way to give a new medicine that could help many people in the future. You will also receive health checks and monitoring throughout the study. Potential risks might include discomfort or bruising at the injection site. As this is an early study, there might be other side effects from the medicine that we don't fully know yet, but you will be closely monitored for any changes to your health. You will also have blood taken multiple times. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

QPS Miami
Verified postcode
Miami, United States· Recruiting
Fortrea Clinical Research Unit Limited - Leeds
Verified postcode
Leeds, United Kingdom· Recruiting

Common questions

What is Romosozumab?

Romosozumab is a new medicine that's being studied. This particular trial is looking at how it gets into your body when given as an injection.

What does 'Phase 1' mean?

Phase 1 means this is one of the first times the medicine is being tested in people. The main goal is to understand how it works in the body and if it's safe.

Will I get paid for taking part?

While you won't be paid for taking part, your travel costs and expenses for study visits might be covered. This will be explained in detail by the study team.

What's an injection 'under the skin' (SC)?

An injection under the skin means the medicine is given just below the surface of your skin, usually in your stomach area or thigh, similar to how some diabetes medicines are given.

Will this medicine help my health?

This study is for healthy volunteers and is mainly about understanding how the medicine works in the body. It's not expected to directly improve your health, but it contributes to future medical knowledge.

How to find out more

Amgen Call Center

medinfo@amgen.com 866-572-6436 Official trial record

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