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RecruitingHuman Pharmacology (Phase I)- OtherInterventional

A study to investigate the pharmacokinetics and safety of a single dose of duvakitug in healthy adult participants

This early-stage Phase 1 clinical trial is testing a new experimental medicine called duvakitug in healthy adult volunteers. The main purpose of the study is to check that the medicine is safe to use and to see how the human body handles it after a single dose. Researchers will carefully measure how duvakitug is absorbed, broken down, and cleared from the body over time. Because this is a study for healthy volunteers, participants do not need to have any specific medical condition to join. Doctors and nurses will closely look after everyone who takes part. They will check vital signs, take regular blood samples, and monitor volunteers for any side effects. The information gathered from this study is an important first step in understanding whether duvakitug could eventually be developed to help treat people with medical conditions in the future.

At a glance

Status
Recruiting
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Sanofi-Aventis Recherche & Developpement
Enrolment target
50
Start
17 Mar 2026

What is this study about?

Before any new medicine can be given to patients, researchers must test it very carefully to ensure it is safe. This study is an early-stage clinical trial investigating an experimental medicine called duvakitug. Researchers want to understand its basic effects in humans by giving a single dose to healthy adult volunteers.

A central focus of the study is looking at how the body processes the medicine. Scientists will track how quickly duvakitug enters the bloodstream, how long it remains active, and how it is naturally broken down and removed. This kind of research helps doctors work out what doses might be suitable and safe for future clinical trials.

Healthy volunteers play a crucial role in medical research. By testing a new drug in people without underlying health conditions, doctors can see the medicine's direct effects clearly, without symptoms from an illness or interactions with other regular prescriptions confusing the results.

Every approved medicine used in the NHS today began in trials just like this one. While this study is an early step, the knowledge gained will help scientists decide whether duvakitug has the potential to become a helpful treatment for patients down the line.

Key takeaways

  • This is an early-stage study testing an experimental medicine called duvakitug.
  • The trial is open to healthy men and women aged 18 and over.
  • Participants will receive just one single dose of the medicine.
  • Doctors will monitor blood levels to see how the body processes and removes the drug.
  • Taking part is voluntary, and you are free to leave the study at any time.

Who may be eligible?

This study is looking for healthy adult volunteers aged 18 and older. Both men and women are welcome to take part. Because the trial is designed to see how the medicine works in a healthy system, volunteers should be in good general health without major ongoing illnesses.

To be eligible, you will usually need to be free from regular prescription medications, as other drugs can change how the body processes the study medicine. You will also be asked about your general lifestyle, such as smoking and alcohol use, and whether you have taken part in any other clinical trials recently.

Before anyone joins, the study medical team will carry out a thorough health check. This includes looking at your medical history, running routine blood tests, and checking your heart to make sure it is completely 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.

  1. I am aged 18 or older.
  2. I consider myself to be in good general health.
  3. I do not have any severe or long-term medical conditions.
  4. I am not taking regular prescription medicines that could interfere with the study.
  5. I am willing and able to attend the required clinic visits and have routine blood tests.
Answer every question to see your result.

What does participation involve?

If you take part, you will receive a single dose of the study medicine, duvakitug, which may be given by injection or through a small drip into a vein. Before getting the dose, you will visit the clinic for a screening appointment where doctors check your heart, blood, and general fitness. On the day of your dose, and during follow-up visits, you will have regular health checks, including blood tests and blood pressure measurements, so the team can monitor drug levels in your body. Some studies require a short stay at the clinic, followed by a series of outpatient check-ups over several weeks or months. The study team will provide a complete schedule of all visits before you decide whether to join.

Potential risks and benefits

Taking part in this trial does not offer any direct medical benefit, as you will be receiving an experimental medicine that does not treat an illness you have. However, you will receive a comprehensive health assessment, and your involvement helps doctors develop potential new medicines for others. Because duvakitug is still being researched, there is a risk of side effects. These can range from mild symptoms, like a headache or tiredness, to rarer allergic reactions. A qualified medical team will supervise you closely to protect your safety and manage any issues quickly. Taking part is entirely voluntary, and you are free to withdraw at any time without needing to give a reason.

Locations (1)

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

Common questions

Why do researchers test medicines on healthy people?

Testing a new medicine in healthy people allows doctors to check its safety and see how the body clears it, without other illnesses or regular medicines interfering with the results.

How many doses of duvakitug will I receive?

Participants in this trial will only receive a single dose of the study medicine.

Will I be compensated for my time?

Phase 1 trials for healthy volunteers in the UK often provide financial compensation for your time and travel expenses. The study team can give you full details.

What happens if I experience side effects?

Doctors and nurses will monitor you very closely throughout the trial. If you feel unwell or notice any side effects, medical staff are on hand to provide care immediately.

Can I leave the study if I change my mind?

Yes. Taking part is completely your choice, and you can stop participating at any point without it affecting your standard medical care.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "A study to investigate the pharmacokinetics and safety of a …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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