A Phase 1, Randomized, Double-Blind, Placebo-Controlled study to Evaluate the Safety, Tolerability,and Pharmacokinetics of Single and Multiple Ascending Doses of CBT101 given intranasally in Healthy Male Subjects.
This research is an early-stage study, often called a 'Phase 1' trial, designed to understand a new nasal spray medication named CBT101. The main goal is to check how safe it is and how well the body can handle it when given through the nose. Researchers are giving this new medication to healthy men in different small doses, some getting a single dose and others multiple doses, while some might receive a dummy spray (placebo). This helps compare reactions fairly. The study also aims to see how the body absorbs, uses, and gets rid of the medication. This kind of early research is crucial for developing potential new treatments for neurological conditions.
At a glance
What is this study about?
This study is a very early step in developing a new treatment called CBT101, which is given as a nasal spray. Think of it like taking a brand-new car for its very first test drive – we want to make sure it's safe to drive and understand how it works. In this case, we're giving CBT101 to healthy volunteers for the first time to see if it causes any unexpected problems and how their bodies react to it.
The main goals are to check for any side effects and to understand how much of the medication gets into the body, how long it stays there, and how the body gets rid of it. Participants will be randomly chosen to receive either CBT101 or a 'dummy' spray (a placebo) that looks and feels the same but contains no active medicine. This helps researchers compare the effects accurately without knowing who received what until the end.
This type of research is vital because it lays the groundwork for future studies. If CBT101 proves safe and well-tolerated in healthy individuals, it could eventually be studied in people living with neurological conditions, potentially offering a new way to manage their health.
Key takeaways
- This is an early-stage study (Phase 1) of a new nasal spray called CBT101.
- The main goals are to check the medication's safety and how the body handles it.
- It involves healthy male volunteers aged 18 and over.
- Participants will receive either the active medication or a placebo (dummy spray).
- This research aims to help develop potential treatments for neurological conditions.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, we are looking for men who are 18 years old or older. There is no upper age limit, meaning older men can also take part if they meet the other requirements.
Since this is a very early-stage study, the researchers need participants who are generally healthy. This means you shouldn't have any major ongoing health problems or illnesses that could affect how the medication works or make it unsafe for you to participate.
The study is specifically looking for men, so women cannot take part in this particular trial. This is common in early studies to carefully observe how a new medication affects one group of people before expanding to others.
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 male?
- Are you 18 years old or older?
- Are you generally in good health?
- Are you able to attend study visits as required?
What does participation involve?
If you decide to take part, you would receive the study medication, CBT101, as a nasal spray, or a placebo spray. You would be given either a single dose or several doses over a period. You would need to visit the study clinic regularly for health checks, blood tests, and other assessments to see how your body is reacting to the medication. These visits help the research team keep a close eye on your safety and how the medication is working in your body. We don't have information on the exact number of visits or the total duration provided in the brief summary, but these details would be fully explained by the study team.
Potential risks and benefits
Locations (1)
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Common questions
What is a 'Phase 1' study?
It's the very first time a new medication is given to people. The main goal is to check its safety and how the body handles it, rather than whether it treats a disease.
What are 'neurological conditions'?
These are health problems affecting the brain, spinal cord, and nerves, like Parkinson's disease, Alzheimer's disease, or multiple sclerosis. This study isn't treating these, but is an early step towards future treatments.
What does 'double-blind' mean?
It means neither you nor the study team will know if you're getting the active medication or a dummy spray (placebo). This helps ensure fair and unbiased results.
Why are only men included in this study?
Often, early studies like this focus on one group (e.g., healthy male volunteers) to understand the medication's basic effects before expanding to other groups, such as women.
Will I have to pay to join this study?
No, you should never have to pay to participate in a clinical trial. Any study-related care and medication will be provided free of charge.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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