A Study of LY4213663 in Healthy Participants and Participants With Rheumatoid Arthritis
This research is looking at a new medicine called LY4213663 for people with rheumatoid arthritis (RA). The main aim is to find out how safe it is and what side effects it might have in both healthy people and those with RA. Scientists also want to understand how the body uses and processes this new medicine. The medicine will be given either as a shot under the skin or through a drip into a vein. Participants will have blood tests to see how the medicine acts in their bodies. The study will last about 33 weeks, not including the first check-up period. It's a 'Phase 1' study, which means it's one of the first times this medicine is being tested in people.
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¿De qué trata este estudio?
This study is about a new medicine called LY4213663, which is being developed to treat rheumatoid arthritis (RA). RA is a condition where your body's immune system mistakenly attacks your own healthy tissues, causing pain, swelling, and stiffness in your joints. Finding new and better treatments is very important for people living with RA.
The main goal of this study is to learn more about this new medicine. Specifically, researchers want to see if it's safe to use, what side effects people might experience, and how the body handles the medicine. They also want to understand how the medicine affects the body once it's taken. By carefully studying healthy volunteers first, and then people with RA, scientists can gather important information in a safe and step-by-step way.
Understanding how a new medicine works and ensuring it's safe is the first important step before it can be made widely available. This 'Phase 1' study is crucial for gathering this early information and helping decide if the medicine should be studied further in larger groups of people. Every new treatment starts with studies like this one, carefully checking for safety and how the medicine behaves in the body.
Puntos clave
- This study is testing a new medicine (LY4213663) for rheumatoid arthritis.
- It aims to find out if the medicine is safe and what side effects it might cause.
- Both healthy people and those with rheumatoid arthritis can take part.
- The medicine will be given either as a shot or through a drip.
- The study involves blood tests and lasts about 33 weeks.
- Your health will be closely monitored throughout the study.
¿Quién puede ser elegible?
To join this study, you'd generally need to be between 18 and 75 years old. Your body mass index (BMI), which is a measure of your weight compared to your height, needs to be within a certain range.
If you have rheumatoid arthritis, you must have been diagnosed with it for at least three months. It's also important that your RA isn't too severe (not 'Class 4' according to a standard medical classification). You should not have any current or recent serious infections, and your heart health will be checked.
If you are a healthy person interested in taking part, you should not have any major long-term health problems with your heart, lungs, liver, kidneys, or other major body systems that could affect how the medicine works in your body.
¿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.
- ¿Tienes entre 18 y 75 años?
- Is your weight for your height (BMI) within a healthy range?
- If you have RA, have you been diagnosed for at least 3 months?
- Do you currently have any serious active infections?
- Do you have any major heart problems?
- Do you have severe rheumatoid arthritis (Class 4)?
¿En qué consiste la participación?
If you decide to take part, you'll first have a screening visit to check if the study is right for you. If you qualify, you will receive the study medicine, LY4213663, either as a small injection under your skin or through a drip directly into a vein in your arm. Some participants might receive a placebo, which looks like the study medicine but contains no active ingredient. This helps researchers compare the effects of the real medicine.
You'll have regular blood tests to help the study team understand how the medicine is working in your body and how your body is responding to it. You will also have check-ups to monitor your health and look for any side effects. The total time you'll be involved in the study, not including the initial screening, will be around 33 weeks.
Riesgos y beneficios potenciales
Locations (10)
- Pinnacle Research Group, LLCCódigo postal verificadoAnniston, United States· Reclutamiento
- Arizona Research CenterCódigo postal verificadoPhoenix, Estados Unidos· Reclutamiento
- Clinical Research of West Florida, Inc. (Clearwater)Código postal verificadoClearwater, United States· Reclutamiento
- GNP Research at Mark Jaffe, MDCódigo postal verificadoCooper City, United States· Reclutamiento
- Fortrea Clinical Research UnitCódigo postal verificadoDaytona Beach, United States· Reclutamiento
- AGA Clinical TrialsCódigo postal verificadoHialeah, Estados Unidos· Reclutamiento
- Advanced Pharma CR, LLCCódigo postal verificadoMiami, United States· Reclutamiento
- Floridian Clinical ResearchCódigo postal verificadoMiami Lakes, Estados Unidos· Reclutamiento
- Oasis Clinical ResearchCódigo postal verificadoLas Vegas, United States· Reclutamiento
- Universitätsklinikum CharitéCódigo postal verificadoBerlín, Alemania· Aún no reclutando
Preguntas comunes
¿Qué es la artritis reumatoide?
Rheumatoid arthritis (RA) is a condition where your body's immune system attacks your joints, causing pain, swelling, and stiffness.
¿Qué significa 'Fase 1'?
Phase 1 means this is one of the first times the new medicine is being tested in people to check its safety and how it works in the body.
¿Qué es un placebo?
A placebo looks just like the study medicine but doesn't contain any active drug. It helps researchers compare the effects of the real medicine.
¿Cómo se administrará el medicamento?
The medicine will be given either as an injection under the skin (subcutaneously) or through a drip into a vein (intravenously).
¿Cuánto tiempo durará el estudio?
The study will last about 33 weeks, not including the initial check-up period.
Cómo obtener más información
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
Discusión
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Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.