Comparative PK/PD of FMXIN002 and EpiPen, in Healthy Adults With Allergic Rhinitis
This research is looking at a new way to deliver epinephrine, a medicine used for severe allergic reactions. Instead of an injection like an EpiPen, this new method (called FMXIN002) is a powder sprayed into the nose. We want to see how quickly and effectively this nasal powder works compared to the standard EpiPen. The study includes healthy adults with a history of hay fever. We will test different doses of both the new nasal powder and the EpiPen, both when the nose is clear and when it's stuffy. We'll be carefully measuring how the medicine gets into the body and how it affects important body functions, while also checking for any side effects.
At a glance
What is this study about?
This study is investigating a new potential treatment for very serious allergic reactions, known as anaphylaxis. Currently, a common treatment is the EpiPen, which delivers medicine through an injection. This research is exploring a new option called FMXIN002, which is a powder sprayed into the nose. The main goal is to understand how well and how quickly this new nasal powder works compared to the EpiPen.
We will be looking at how the medicine is absorbed by the body and what effects it has on your body's systems. Participants will receive different doses of both the nasal powder and the EpiPen. We'll also test these treatments both when your nose is clear and when it's congested, because we want to know if a stuffy nose affects how well the nasal spray works. This is important because allergic reactions can sometimes cause nasal congestion.
By comparing these two ways of getting the medicine, we hope to learn if the new nasal powder could be a useful and user-friendly alternative to injections for people who experience severe allergies. The information gathered will help us understand if this new treatment is safe and effective.
Key takeaways
- This study compares a new nasal powder to EpiPen for severe allergies.
- It's for healthy adults aged 18-55 with a history of hay fever.
- Participants will stay in a clinic to receive different doses and have health checks.
- The study looks at how the body uses the medicine and its effects.
- It aims to find out if the nasal powder is a safe and effective option.
Who may be eligible?
To join this study, you need to be a healthy adult between 18 and 55 years old, and you shouldn't smoke. You must have a confirmed allergy (shown by a skin test) and have experienced hay fever or seasonal allergies in the past year. Your body mass index (BMI) should be between 18 and 30.
If you are a woman who could become pregnant, you'll need to agree to use effective birth control during the study. If you cannot become pregnant (for example, if you've had surgery to remove your ovaries or uterus, or you're past menopause), you can also take part. Everyone must be able to have blood taken from their veins easily.
You cannot participate if you have any serious long-term health conditions like problems with your heart, lungs, immune system, or other major body systems. Also, if you are pregnant, breastfeeding, or have recently changed certain hormonal contraceptives, you won't be able to join. We need to make sure the study is safe for you and that the results are clear.
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 55 years old?
- Do you have a confirmed allergy (positive skin test)?
- Have you experienced hay fever or seasonal allergies in the last year?
- Do you have a healthy weight (BMI between 18 and 30)?
- Are you able to provide blood samples comfortably?
- Do you have good overall health without serious medical conditions?
What does participation involve?
If you join this study, you will stay in a clinic for several periods. During your stay, you will receive single and sometimes double doses of different treatments. This includes the new nasal powder (FMXIN002) and the EpiPen injection. We will also make your nose slightly congested using a harmless allergen, similar to what happens during hay fever, to see how the treatments work under those conditions. You might receive the nasal spray in the same nostril multiple times or in different nostrils.
Throughout these periods, doctors and nurses will regularly take blood samples to measure how much medicine is in your body. They will also monitor your heart rate, blood pressure, and other vital signs to see how the medicine affects you. Your safety will be checked closely, and any side effects will be recorded. The exact total duration of your participation, including all clinic stays and follow-up, will be explained in detail.
Potential risks and benefits
Locations (1)
- Pharma Medica Research IncVerified postcodeMississauga, Canada
Common questions
What is anaphylaxis?
Anaphylaxis is a severe, life-threatening allergic reaction that can affect your breathing, blood pressure, and other body systems.
What is epinephrine?
Epinephrine is a medicine that quickly acts to reverse the serious symptoms of an allergic reaction like anaphylaxis.
What does 'PK/PD' mean?
PK (pharmacokinetics) means how your body handles the medicine (how it gets absorbed, distributed, processed, and removed). PD (pharmacodynamics) means what the medicine does to your body.
Will I get paid for taking part?
The study will provide more information about any compensation for your time and inconvenience.
What's 'allergic rhinitis'?
Allergic rhinitis, commonly known as hay fever, is when your nose gets irritated and runny due to allergens like pollen.
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
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.