Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

An Early Phase Study to Investigate the Safety and Efficacy of HS135 in Adult Patients With Pulmonary Arterial Hypertension (PAH)

This study is a very early investigation into a new potential treatment, known as HS135, for adults living with pulmonary arterial hypertension (PAH). PAH is a serious condition where blood pressure in the arteries leading to the lungs becomes very high, making it harder for the heart to pump blood. The main purpose of this study is to carefully check if HS135 is safe for people to take and to get an early idea of whether it might help improve their condition. This type of study, often called a 'Phase 1' study, is usually the first time a new medicine is given to humans after extensive laboratory testing. It’s a crucial step in understanding if HS135 could become a helpful medication in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

35Pharma Inc.

Enrolment target

Start

24 Jun 2024

Pulmonary arterial hypertension

What is this study about?

This study is about a new medicine called HS135, which is being tested for a serious lung condition known as pulmonary arterial hypertension, or PAH. If you have PAH, the blood vessels in your lungs become narrow and stiff. This makes it very hard for your heart to pump enough blood through your lungs, causing symptoms like breathlessness, tiredness, and chest pain. Treating PAH is very important, and doctors are always looking for new ways to help.

The main goal of this particular study is to learn more about HS135. Because it's a new medicine, researchers first need to make sure it's safe for people to take. They will also be looking to see if it has any positive effects on the body that might help people with PAH. It's like taking a very careful first look at a new invention – you want to make sure it works properly and doesn't cause any unexpected problems.

This kind of study is called a 'Phase 1' study. It means it's one of the very first times this medicine is being given to people. This phase is less about curing the condition and more about understanding how the medicine behaves in the human body, such as how it's absorbed, distributed, and processed, and critically, if it causes any side effects. The information gathered from this study is vital for deciding if HS135 should be tested further in larger studies.

Key takeaways

It's an early study of a new medicine (HS135) for PAH.
The main goals are to check safety and how the medicine works in the body.
Open to adults aged 18 and over, both men and women, with PAH.
Involves regular clinic visits and careful monitoring.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you need to be an adult, meaning you must be 18 years old or older. There is no upper age limit, so older adults can also take part if they meet the other requirements. The study is open to both men and women.

Beyond simply being an adult, you would need to have a confirmed diagnosis of pulmonary arterial hypertension (PAH). Researchers will have specific medical criteria about how severe your PAH needs to be or what other treatments you might already be on. These details are important for making sure the study is safely conducted and that the results are clear.

There will also be other health conditions or medicines that might mean you couldn't take part. For example, if you have certain kidney or liver problems, or are taking medications that could interact with the study drug, you might not be eligible. This is all to ensure your safety and that the study design allows for accurate results.

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.

Am I 18 years old or older?
Have I been diagnosed with pulmonary arterial hypertension (PAH)?
Am I able to attend regular clinic appointments?
Am I comfortable taking a new, experimental medicine?

Answer every question to see your result.

What does participation involve?

Taking part in this study would involve a series of visits to a clinic or hospital over a specific period. You would receive the study medicine, HS135, which could be given in different ways depending on the study design (e.g., as tablets or injections). Researchers would regularly monitor your health very closely. This would include physical examinations, blood tests, heart checks like ECGs, and possibly other tests related to your PAH to see how you are responding to the medicine.

You would be asked to report any new symptoms or side effects you experience. There will be a detailed schedule of when to take the medicine and when to attend appointments. After the main treatment period, there would likely be follow-up visits to ensure your health remains stable and to track any longer-term effects of the medicine. The total duration of your participation, from your first screening visit to your last follow-up, would be clearly explained to you.

Potential risks and benefits

Participating in an early-stage study like this has potential benefits, though they are not guaranteed. You might have access to a new medicine well before it's widely available, and it's possible HS135 could help improve your PAH. However, the main goal of this study is to gather information, not necessarily to provide you with a cure. There are also potential risks; as HS135 is new, there might be unknown side effects or it might not work for you. Very rarely, new medicines can cause serious problems. You will be closely monitored for any adverse effects. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Hungary
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Unverified
Poland
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Unverified
Germany

Common questions

What is pulmonary arterial hypertension (PAH)?

PAH is a serious condition where the blood vessels in your lungs become too narrow, making it hard for your heart to pump blood to your lungs.

What is HS135?

HS135 is a new medicine being tested to see if it can help adults with PAH. It's currently in early stages of research.

What does 'Phase 1 study' mean?

It means this is one of the very first times this new medicine is being given to people. The main aim is to check its safety and how it acts in the body.

Will I get better if I join this study?

It's not guaranteed. While we hope the medicine might help, the main purpose of this early study is to understand its safety and how it works, not primarily to cure your condition.

Can I stop participating if I want to?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care.