Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Double-Blind, Randomized, Placebo-Controlled, Phase 1b, Pharmacodynamic Trial of TEV-56192 Following a Single Intravenous Administration in Healthy Participants

This study is an early-stage clinical trial looking into a new medicine called TEV-56192. It's being tested in healthy volunteers to understand how it works in the body after they receive a single dose directly into their bloodstream. This type of study, often called a Phase 1b trial, helps researchers learn about the medicine's effects and how the body reacts to it. Because it's an early safety study, participants will not be treated for a specific illness. This study is crucial for gathering important information about the medicine before it's tested in people who have a condition that it might one day treat, such as pruritus (itchy skin).

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Teva Branded Pharmaceutical Products R&D Inc.

Enrolment target

Start

22 Feb 2024

Pruritus

What is this study about?

Imagine scientists have developed a new key, and they want to see what kind of lock it fits and how it turns. That's a bit like what this research study is doing, but with a new medicine called TEV-56192. This study is a very early step in testing this medicine.

Researchers are giving a single dose of TEV-56192 to healthy volunteers or a 'dummy' medicine (placebo), without either the volunteers or the research team knowing who gets which – this is called 'double-blind'. They want to carefully watch what happens inside the body after taking it. They're particularly interested in how the medicine acts at a cellular or molecular level, which is what 'pharmacodynamic' means. This helps them understand if the medicine is doing what they expect it to do.

While the medicine might eventually be used for conditions like pruritus (which is the medical term for severe itching), this study isn't about treating an illness right now. It's purely about understanding more about the medicine itself in healthy people. This initial information is really important before it can be tested in people who actually have pruritus or other conditions.

Key takeaways

This study is testing a new medicine, TEV-56192, for the first time in healthy humans.
It aims to understand how the medicine works in the body after a single dose.
Participants will either receive the medicine or a placebo (dummy medicine).
Neither participants nor the study team will know who receives what (double-blind).
It's an early-stage safety study, not a treatment trial for an illness.
Volunteers must be healthy and aged 18 or older.

Who may be eligible?

To be able to take part in this study, you need to be a healthy adult aged 18 or older. Researchers are looking for people who are generally well and don't have any major ongoing health problems.

Both men and women are welcome to volunteer for this trial, as the study needs to understand how the medicine works across different people. You don't need to have any specific health condition or illness to join.

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 18 years old or older?
Are you generally healthy with no major ongoing medical conditions?
Are you comfortable receiving medicine through a drip into your arm?
Are you able to attend all required study visits?
Are you willing to potentially receive a placebo instead of the active medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a single dose of either the study medicine (TEV-56192) or a placebo, which looks just like the real medicine but has no active ingredients. Neither you nor the study team will know which one you receive. This medicine will be given to you directly into your bloodstream through a drip.

Throughout the study, you'll have several visits to the clinic or hospital. These visits will involve various checks, such as blood tests, urine tests, and monitoring your vital signs like blood pressure and heart rate. These assessments help the researchers understand how your body is reacting to the medicine. The total duration of your involvement, including any follow-up appointments, will be explained in detail by the study team.

Potential risks and benefits

Potential benefits for participants are generally indirect; you might contribute to new medical knowledge that could help others in the future. There is no guarantee you will personally benefit from taking part. Potential risks could include side effects from the medicine, discomfort from blood tests, or allergic reactions. The research team will carefully explain all known risks. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Denmark

Common questions

What is pruritus?

Pruritus is the medical term for itchy skin. It can be caused by many different things and can be very uncomfortable.

What does 'single intravenous administration' mean?

It means the medicine will be given into a vein, usually in your arm, in one single dose through a drip.

Will I know if I'm getting the real medicine or a placebo?

No, because this is a 'double-blind' study, neither you nor the study staff will know whether you're receiving the active medicine or a placebo.

Why test on healthy people first?

Testing on healthy volunteers helps researchers understand how a new medicine behaves in the body and if it's safe at certain doses before trying it on people who are unwell.

What is a Phase 1b trial?

Phase 1b trials are early studies in healthy volunteers or sometimes a small group of patients, mainly focused on safety, how the body handles the medicine, and how it acts.