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ReclutamientoFarmacología Humana (Fase I) - Primera administración en humanosIntervencionista

Study to assess the safety and tolerability of CMR316 in healthy volunteers and patients with Idiopathic Pulmonary Fibrosis.

Idiopathic pulmonary fibrosis (IPF) is a serious, long-term condition where lung tissue becomes scarred and stiff, making it harder to breathe over time. Currently, there is a strong need for newer and more effective treatments. This study is a 'Phase 1' trial, which means it is the very first time the experimental medicine, called CMR316, is being tested in humans. The main goal is not yet to prove that the drug improves lung function, but to ensure that it is safe, check for any unwanted side effects, and see how the body handles it. The trial is open to adults aged 18 and over, including both healthy volunteers and people who have been diagnosed with IPF. Taking part helps scientists gather vital information that could shape future treatments for lung disease.

De un vistazo

Estado
Reclutamiento
Fase
Farmacología Humana (Fase I) - Primera administración en humanos
Patrocinador
The Scripps Research Institute
Objetivo de inscripción
112
Inicio
09 Apr 2024

¿De qué trata este estudio?

Idiopathic pulmonary fibrosis, often called IPF, is a condition that causes progressive scarring in the lungs. Over time, this scarring makes the lungs less flexible, leading to shortness of breath, a persistent dry cough, and tiredness. While existing treatments can help slow down the disease, they cannot cure it or reverse existing scars. Because of this, medical researchers are continually searching for new medicines that can better manage or halt the condition.

This trial focuses on a new drug known as CMR316. Before any new medicine can be used in clinics, it must go through careful testing. This is a Phase 1 clinical study, which represents the very first step of human testing. The main purpose is human pharmacology, which means scientists want to observe how the drug behaves inside the body, how it is broken down, and whether it causes any uncomfortable or harmful side effects.

To build a full safety profile, the researchers are inviting both healthy volunteers and people living with IPF to take part. Testing the medicine in healthy individuals shows how it works under normal conditions, while testing it in people with IPF helps researchers understand how the disease itself might affect how the medicine works.

Although Phase 1 trials are not designed to cure the illness, the knowledge gained from them is essential. Every modern medicine used in the NHS today began with early safety studies like this one. By taking part, participants help provide the fundamental evidence needed to decide if CMR316 should move forward into larger studies.

Puntos clave

  • Tests a new investigational drug called CMR316 in humans for the first time.
  • Aims to check the safety, tolerability, and side effects of the medicine.
  • Open to adults aged 18 and older, including both healthy volunteers and IPF patients.
  • Participation involves health checks, breathing tests, and regular monitoring visits.
  • Taking part is completely voluntary and you can withdraw at any point.

¿Quién puede ser elegible?

This trial is open to adults aged 18 and over. It is looking for two distinct groups of people: healthy volunteers who do not have serious long-term medical conditions, and patients who have received a confirmed diagnosis of idiopathic pulmonary fibrosis (IPF).

Because this is an early safety trial, there are strict health rules to protect participants. People who are pregnant, breastfeeding, or planning a pregnancy during the trial may not be able to join. The researchers will also check your medical history to ensure you do not have other serious health problems that could make taking an experimental drug unsafe.

The research team will review your full medical records, any medicines you currently take, and your overall fitness before you can be accepted into the study.

¿Podría este estudio ser adecuado para ti?

Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.

  1. I am aged 18 or older.
  2. I am either a healthy volunteer or I have a diagnosis of idiopathic pulmonary fibrosis (IPF).
  3. I am willing and able to travel to the study site for regular health checks and tests.
  4. I am happy to have routine medical checks, such as blood tests, heart traces, and breathing assessments.
  5. I am not currently pregnant or breastfeeding.
Responde cada pregunta para ver tu resultado.

¿En qué consiste la participación?

Taking part begins with a detailed screening visit to ensure the study is safe and appropriate for you. During this appointment, the medical team will carry out health checks, which usually include blood and urine tests, heart traces (ECGs), blood pressure checks, and lung function breathing tests. If you are accepted, you will be given CMR316 under close medical observation. You will be monitored regularly at the study clinic so doctors can check how your body responds and record any symptoms you feel. The trial will involve several clinic visits, and you will be asked to attend follow-up appointments after your final dose to ensure you remain well.

Riesgos y beneficios potenciales

Because this is a Phase 1 study, you should not expect to receive any direct medical benefit to your health from taking CMR316. The primary benefit is contributing to scientific knowledge that may help develop new treatments for lung disease in the future. As with any new medicine being tested in humans for the first time, there is a risk of unexpected side effects or allergic reactions, as well as minor discomfort from routine tests like blood sampling. You are free to leave the trial at any time without giving a reason, and deciding not to take part or withdrawing early will never affect your regular NHS care.

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Preguntas comunes

What is a Phase 1 clinical trial?

A Phase 1 trial is the earliest stage of human testing. It focuses mainly on safety, checking for side effects, and seeing how the body breaks down a new drug.

Will taking this drug improve my breathing?

It is unlikely. Phase 1 trials are designed to test safety and dosage rather than to treat or cure your condition.

¿Puedo abandonar el estudio si cambio de opinión?

Yes. Taking part is completely voluntary, and you can withdraw at any time without affecting your normal healthcare.

Why are healthy volunteers included in an IPF study?

Testing the medicine in healthy people allows doctors to understand how the drug behaves in a normal body before comparing it to people with lung disease.

Will I have to pay to take part?

No, the trial medicine and all tests are free. Many clinical trials also help cover reasonable travel expenses for attending clinic visits.

Cómo obtener más información

Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.

¿Interesado en participar?

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