A RANDOMIZED PHASE I, DOUBLE-BLIND, PARALLEL, COMPARATIVE ASSESSMENT OF PHARMACOKINETICS, SAFETY, PHARMACODYNAMICS, AND IMMUNOGENICITY OF LT-01 (AN OMALIZUMAB BIOSIMILAR CANDIDATE [TEST]) LYOPHYLIZED POWDER FOR SUBCUTANEOUS INJECTION VERSUS EU-APPROVED XOLAIR® LYOPHYLIZED POWDER FOR SUBCUTANEOUS INJECTION (REFERENCE) IN HEALTHY SUBJETCS: CIMA STUDY.
This research is looking at a new medicine, called LT-01, which is very similar to an existing medicine called Xolair. Xolair is used to treat conditions like long-lasting hives, severe asthma, and sinus problems with polyps. This study wants to see if LT-01 works in the body in the same way as Xolair, if it's safe, and if it causes similar immune responses. Researchers will give either LT-01 or Xolair by injection to healthy volunteers. This is an early stage study (Phase I) that aims to confirm that the new medicine is effectively the same as the original, but it's not testing its effects on specific illnesses yet. It's a 'blinded' study, meaning neither the participants nor their doctors will know which medicine they are receiving until after the study is over.
At a glance
What is this study about?
Imagine there's a well-known medicine that helps people with certain conditions like persistent itchy hives, some types of asthma, or sinus problems where growths called polyps appear. Now, imagine a company has developed a new medicine that aims to be just like that established medicine, but perhaps it could be more widely available or less expensive in the future. This study, called CIMA, is the very first step in checking if this new medicine, called LT-01, is indeed nearly identical to the original medicine, Xolair.
Researchers are giving either LT-01 or Xolair to healthy volunteers, meaning people who don't have the conditions Xolair normally treats. The main goal is to compare how each medicine behaves in the body. They want to see if the body absorbs and processes LT-01 in the same way as Xolair, if it's equally safe, and if it creates a similar response from the body's immune system. This type of study is called a 'bioequivalence' study, and it helps ensure that new versions of medicines are just as good as the original.
This early stage of research is very important but doesn't test if the new medicine can treat illnesses yet. It focuses purely on understanding how the medicine works in healthy people before it can be considered for patients. If LT-01 proves to be very similar to Xolair, it could eventually offer another option for treating the conditions mentioned earlier.
Key takeaways
- This study compares a new medicine (LT-01) with an existing one (Xolair).
- It aims to see if the new medicine works the same way and is as safe in healthy people.
- Participation involves injections, blood tests, and clinic visits over a set period.
- This is an early-stage study, not testing treatment for specific illnesses yet.
- You won't know which medicine you're receiving during the study.
- You can withdraw from the study at any time.
Who may be eligible?
To be considered for this study, you need to be an adult, at least 18 years old. Both men and women are welcome to take part. The most important thing is that you should be a healthy person without any ongoing medical conditions that would interfere with the study or be affected by the medicines being tested.
Because this study is comparing how the medicines work in a healthy body, people with conditions like chronic hives, asthma, or sinus polyps, which Xolair normally treats, would not be suitable for this particular trial. Also, if you have any other significant health problems or take certain medications, you might not be able to participate.
The research team will need to thoroughly check your health to make sure you fit all the necessary criteria to join the study safely.
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 healthy with no known ongoing medical conditions?
- Are you able to attend all required clinic visits?
- Are you comfortable with receiving injections under your skin?
- Are you not currently pregnant or breastfeeding, if applicable?
What does participation involve?
If you decide to take part in this study, you would receive either the new medicine (LT-01) or the existing medicine (Xolair) as an injection under your skin. Neither you nor the study doctors would know which one you are getting. You would need to attend several visits to the study clinic for assessments. These visits would involve blood tests to see how the medicine is working in your body, checks of your overall health, and discussions about any side effects you might experience.
The total duration of your participation and the number of visits would be clearly explained by the study team. They would also tell you about any specific instructions you need to follow, such as what you can and cannot eat or drink before certain appointments. After receiving the injections, there would be a follow-up period to monitor your health and collect more information about the medicine.
Potential risks and benefits
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Common questions
What is a 'biosimilar' medicine?
A biosimilar is like a highly similar copy of an existing approved medicine. It's not an exact chemical duplicate, but it's proven to work in the body in the same way.
Why use healthy people for this study?
Using healthy people in early studies helps researchers understand how the medicine behaves in the body without the complications of an existing illness. This ensures it's safe before being tested in patients.
Will I get paid for taking part?
Study participation often includes compensation for your time and travel, but you should ask the study team for specific details.
What does 'double-blind' mean?
Double-blind means neither you nor your study doctor will know whether you are receiving the new medicine or the existing one. This helps keep the results unbiased.
How is the medicine given?
The medicine will be given as an injection just under the skin, similar to how many vaccines are given.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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