A healthy volunteer study of MOS-118 nasal spray
This research is looking at a new nasal spray, MOS-118, designed to help people with obstructive sleep apnoea (OSA). OSA causes breathing to stop and start during sleep, leading to low oxygen and tiredness. Currently, there are no specific medications for it. This spray aims to stop throat muscles from collapsing during sleep. This is a 'Phase I' study, meaning it's the first time it will be tested in people. We're looking for healthy adults aged 18-65. The study will check how safe the spray is, how well people tolerate it, where it goes in the nose and throat, and how much of it gets absorbed into the blood. This information is key to developing new treatments for OSA.
At a glance
What is this study about?
Obstructive sleep apnoea (OSA) is a common condition where the muscles in your throat relax too much during sleep. This causes your airway to narrow or even close completely, leading to pauses in breathing, snoring, and disturbed sleep. Over time, this can lead to low oxygen levels in your body and leave you feeling very tired during the day. While there are treatments for OSA, like breathing masks, there isn't yet a specific medication that can successfully treat the condition.
Mosanna Therapeutics has developed a new nasal spray called MOS-118. The idea behind this spray is that it might temporarily change how the muscles in your throat and upper airway behave, making them less likely to collapse while you sleep. If successful, this could offer a new and easier way to manage OSA for many people.
This particular study is a very early stage of testing, often called a 'Phase I' study. This means we're evaluating the spray for the first time in healthy volunteers, not people with sleep apnoea. The main goals are to find out if the spray is safe, to see how well people tolerate it (meaning if it causes any discomfort or side effects), and to understand how it behaves in the body – for example, where it goes after you spray it in your nose and throat, and how much of the medicine gets into your bloodstream. This information is vital before it can be tested in people who actually have sleep apnoea.
Key takeaways
- This study tests a new nasal spray (MOS-118) for sleep apnoea in healthy people.
- It's a 'Phase 1' study, focusing on safety and how the spray works in the body.
- Participants will have multiple visits, including some overnight stays.
- You'll receive different versions of the spray, including a dummy spray (placebo).
- There's no direct health benefit for participants, but it helps future sleep apnoea treatment.
- A small, safe amount of radiation will be used to track the spray.
Who may be eligible?
To join this study, you need to be a healthy adult between 18 and 65 years old. This applies to both men and women. Your health will be checked by the study doctor to make sure you're suitable.
There are also some requirements about your body weight and keeping to the study schedule. If you're a woman, you can't be pregnant or breastfeeding, and you'll need to use effective birth control if there's any chance you could become pregnant. Men will also need to follow specific guidelines on contraception.
These rules are in place to help make sure the study results are clear and that participants are kept as safe as possible. The study team will go through all the details with you if you're interested.
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 65 years old?
- Are you generally healthy, as confirmed by a doctor?
- Do you have a Body Mass Index (BMI) between 18 and 32?
- Are you able to follow all study instructions and attend all appointments?
- If you are a woman, are you not pregnant or breastfeeding, and willing to use effective contraception?
- If you are a man, are you willing to follow specific contraception guidelines?
What does participation involve?
If you decide to take part, the study will last about 10 weeks in total. It will involve a few different visits:
First, you'll have a screening visit to check if you're suitable for the study. If you are, you'll then come in for 5 treatment visits. For four of these treatment visits, you'll stay overnight at the study site for about 26 hours. Finally, there will be a follow-up visit to make sure everything is okay.
During your treatment visits, you will receive five different treatments. This includes a 'placebo' (a spray with no active medicine) and four different versions of the MOS-118 spray. Each time you receive the MOS-118 spray, it will contain the same amount of medicine, but the ways the spray is prepared might be slightly different. To see how the spray moves around your nose and throat, a tiny, safe amount of radiation will be added to the active sprays, and doctors will take special pictures (like X-rays) to track it. You'll also have blood samples taken at each treatment visit to see how much of the medicine gets into your body.
Potential risks and benefits
Locations (1)
- BDD Pharma LtdCity onlyGlasgow, Scotland
Common questions
What is obstructive sleep apnoea?
It's a condition where your breathing stops and starts repeatedly during sleep because the muscles in your throat relax and block your airway. This can lead to snoring, restless sleep, and feeling very tired during the day.
What is a 'Phase I' study?
It's the first stage of testing a new medicine in people. The main purpose is to check if it's safe, how well the body tolerates it, and how it works in the body, usually in a small group of healthy volunteers.
Will this spray cure my sleep apnoea if I have it?
This study is a very early step and is being done in healthy volunteers, not people with sleep apnoea. The goal is to see if the spray is safe and how it works. It's too early to know if it will cure sleep apnoea, but it might lead to a new treatment in the future.
Will I be exposed to radiation?
Yes, a very small, safe amount of radiation will be added to the active sprays to track their movement in your body. This amount is similar to what you might get from routine medical imaging.
Will I get paid for taking part?
The study information doesn't specifically mention payment, but it's common for healthy volunteer studies to offer compensation for your time and expenses. You should ask the study team about this.
How to find out more
Lyn Corry
Always speak to your GP or specialist before deciding to take part in a study.
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