A single dose, randomized, double-blind 2-arm parallel-group study to compare the pharmacokinetics, immunogenicity, and safety for PB016 versus US-licensed Entyvio® after subcutaneous administration in healthy participants
This clinical trial is looking at a new medicine called PB016. It is designed to be a 'biosimilar' version of Entyvio (vedolizumab), an approved medicine used to treat bowel conditions like Crohn's disease and ulcerative colitis. A biosimilar is made to work in the exact same way as the original medicine, often making vital treatments more affordable. In this study, healthy adult volunteers will receive a single injection under the skin of either PB016 or Entyvio. Neither the volunteers nor the study doctors will know who gets which medicine until the trial ends. Researchers will carry out regular health checks and blood tests to compare how both medicines move through the body, check for any immune system reactions, and ensure safety. This early research helps confirm whether the new medicine behaves identically to the trusted original.
At a glance
What is this study about?
This clinical trial is evaluating a new medicine known as PB016. It is being developed as a 'biosimilar' to Entyvio, an established biological medicine commonly prescribed for inflammatory bowel diseases such as ulcerative colitis and Crohn's disease. Biological medicines are complex treatments made from living cells. When the original patent expires, other companies can create biosimilars that work in the exact same way, helping to provide safe, high-quality alternatives that cost less for healthcare services like the NHS.
Before a biosimilar can be approved for patients, researchers must show that it behaves just like the original medicine. In this trial, researchers are comparing the 'pharmacokinetics' (how the body absorbs, breaks down, and clears the drug) and 'immunogenicity' (whether the body's immune system reacts against the drug) of both PB016 and Entyvio.
Because this is an early-stage study, it involves healthy volunteers rather than people living with bowel conditions. Testing the medicine in healthy individuals allows doctors to measure exactly how it acts in the body without the results being influenced by ongoing illness or other long-term medications.
Key takeaways
- Tests a potential biosimilar (PB016) against the approved medicine Entyvio.
- Open to healthy adult volunteers aged 18 and over.
- Involves a single injection given under the skin followed by regular health checks.
- Aims to prove both medicines are processed by the body in the exact same way.
- Participation is completely voluntary and you can withdraw at any time.
Who may be eligible?
This trial is open to healthy adult volunteers aged 18 and older. Because the goal is to see how the medicine acts in a standard, healthy body, participants must be in generally good health with no major long-term illnesses.
You will usually not be eligible if you have serious chronic conditions, such as heart disease, kidney problems, active infections, or digestive diseases. People who are pregnant, breastfeeding, or taking certain regular prescription medicines may also be unable to take part.
A trial doctor will review your full medical history, carry out a thorough physical examination, and run blood and urine tests during a screening visit 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.
- I am aged 18 or older.
- I consider myself to be in good overall health.
- I do not have a history of inflammatory bowel disease or chronic illness.
- I am not currently pregnant or breastfeeding.
- I am willing to attend regular clinic visits and have blood tests taken.
What does participation involve?
Taking part involves an initial screening visit to check your general health and confirm your eligibility. If you join, you will be randomly assigned to receive a single dose of either PB016 or Entyvio given as an injection under the skin, usually in the tummy or thigh.
After the injection, you will be monitored closely by the clinic team. You will need to attend several follow-up visits over a few weeks or months. During these visits, the study team will take blood and urine samples, check your vital signs (such as blood pressure and heart rate), and ask how you are feeling. These tests track how the medicine travels through your body and ensure you remain well throughout the study.
Potential risks and benefits
Locations (1)
- —UnverifiedGermany
Common questions
What is a biosimilar medicine?
A biosimilar is a biological medicine developed to be highly similar to an already approved biological medicine. It has the same safety, quality, and effectiveness as the original treatment.
Why is this trial being done in healthy volunteers?
Testing in healthy volunteers provides a clear, clean picture of how the medicine moves through the human body, without other health conditions or treatments confusing the results.
Will I know which medicine I am receiving?
No. This is a 'double-blind' study, meaning neither you nor the study team will know whether you receive PB016 or Entyvio until the study is completed.
How is the medicine given?
It is given as a single subcutaneous injection, which means a small needle injects the liquid just under the skin, typically into the abdomen or thigh.
Can I leave the study if I change my mind?
Yes. Taking part is entirely voluntary. You can choose to stop and leave the trial at any time, for any reason, and your regular medical care will not be affected.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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