A phase 1, randomised, double-blind, placebo-controlled, single ascending dose and multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics in healthy adult subjects after subcutaneous injection of TISA-818-Inj-5mg/mL.
This study is a very early step in testing a new medicine called TISA-818. This medicine is being developed for a lung condition called idiopathic pulmonary fibrosis, which causes scarring in the lungs. Before trying it in patients, researchers need to understand more about it in healthy people. In this study, healthy adults will receive different doses of TISA-818 by injection under the skin, or a dummy injection (placebo). The main goals are to see how safe the medicine is, if people experience any side effects, and how the body processes the medicine. This helps scientists understand if it's safe enough to continue testing in people living with idiopathic pulmonary fibrosis.
At a glance
What is this study about?
This research study is an important first step in understanding a potential new medicine called TISA-818. This medicine is being studied as a possible treatment for a serious lung condition known as idiopathic pulmonary fibrosis (often shortened to IPF). IPF causes scarring in the lungs, which makes it harder to breathe over time. Finding new ways to treat IPF is very important, and medicines like TISA-818 could be a future option.
Because TISA-818 is new, scientists need to learn a lot about it before it can be given to people who have IPF. This particular study is called a 'Phase 1' study, meaning it's one of the very first times this medicine is being given to humans. In this study, TISA-818 will be given to healthy adults, not people with IPF. This allows researchers to focus purely on how the medicine affects a healthy body without the complications of an existing illness.
Volunteer participants will receive TISA-818 as injections under the skin. Some will get a single dose, while others might get multiple doses over time. Crucially, some participants will receive a 'placebo' – which looks exactly like the study medicine but doesn't contain any active drug. This helps researchers compare the effects of the actual medicine fairly. The main things researchers will be looking at are safety (any unwanted effects), how well people tolerate the medicine (how easily they cope with it), and how the body takes in, uses, and gets rid of the medicine. This information is vital for deciding if TISA-818 is safe and promising enough to move on to later studies involving people with IPF.
Key takeaways
- This study is testing a brand-new medicine, TISA-818, for lung scarring (IPF).
- It's a very early-stage study (Phase 1) focused on checking safety in healthy adults.
- Participants will receive injections of the medicine or a dummy injection (placebo).
- Both men and women, aged 18 and over, in good health, can volunteer.
- You won't directly benefit, but you'll help advance medical research.
Who may be eligible?
This study is looking for healthy adult volunteers to take part. To be eligible, you must be at least 18 years old – there's no upper age limit, as long as you're in good health. Both men and women can participate in this study. The most important thing is that you are generally healthy, as the study needs to find out how the new medicine affects the body without any other health conditions getting in the way.
Before you can join, doctors will perform a careful check-up to make sure you are healthy enough. This will likely involve a medical history review, a physical exam, and some tests. They need to confirm that you have no significant health problems that could affect how the medicine works or put you at risk.
- Am I at least 18 years old?
- Am I generally in good health?
- Am I able to visit the study clinic regularly as needed?
- Am I comfortable with receiving injections?
- Do I understand that I might receive a placebo?
- Am I willing to undergo various health checks and tests?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would receive the study medicine, TISA-818, or a placebo (a dummy injection) as an injection under your skin. Because this is an early-stage study to check safety, you would need to visit the study clinic regularly. Some visits might be longer, perhaps requiring you to stay for a day or even overnight, especially early on, so doctors can carefully monitor you after receiving the medicine.
Throughout the study, you'll have various assessments, including blood tests, urine tests, and physical examinations, to check your health and how your body is handling the medicine. The total number of injections, clinic visits, and how long you are followed up will depend on whether you are in the single dose or multiple dose part of the study, and these details will be fully explained before you agree to take part.
Potential risks and benefits
Locations (1)
- —Sweden
Common questions
What is idiopathic pulmonary fibrosis (IPF)?
IPF is a lung condition where the lungs become scarred, making it harder to breathe. We don't know why it happens.
What does 'Phase 1' mean for a study?
Phase 1 is the very first step of testing a new medicine in people, usually healthy volunteers, to check its safety and how the body handles it.
Will I get the actual medicine or a placebo?
You might get the active medicine, TISA-818, or a placebo (a dummy injection with no active drug). Researchers won't know which one you received until the study is over.
Who can take part in this study?
Healthy adults aged 18 and over, both men and women, can take part. You'll need to pass a health check-up.
Will taking part benefit me directly?
This study is focused on gathering information about the new medicine's safety, so it's unlikely to have a direct health benefit for you, but you'll be helping medical science.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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