Not yet recruitingPHASE1INTERVENTIONAL

Safety, Tolerability, PK, and PD of TGM-148 in Healthy Participants

This study is a very early step in testing a new treatment called TGM-148. Its main goal is to find out if TGM-148 is safe for healthy people and how well their bodies cope with it. We also want to understand how the treatment moves through the body and what effects it might have. Healthy adults between 18 and 45 years old are invited to take part. Participants will be randomly assigned to receive either a single dose of TGM-148 or a 'dummy' treatment, called a placebo, which looks the same but contains no active medicine. This helps researchers compare the effects accurately. This study is crucial for learning more about TGM-148 before it can be tested in people with specific illnesses.

At a glance

Status

Not yet recruiting

Phase

PHASE1

Sponsor

Tangram Therapeutics Plc

Enrolment target

Start

01 Oct 2026

Estimated completion

01 Mar 2028

Healthy Participants

What is this study about?

This study is one of the very first times a new investigational treatment, called TGM-148, will be given to people. It's a 'Phase 1' trial, which means the main focus is on safety. Researchers want to make sure the treatment is safe for healthy adults and to see how their bodies react to it. They will also look at how much of the treatment stays in the body over time and what kinds of effects it has on the body.

To do this, healthy volunteers will receive a single dose of either TGM-148 or a placebo. A placebo looks exactly like the real treatment but contains no active medicine. This helps the researchers compare the results more accurately. It's like having a control group in an experiment, ensuring any changes observed are likely due to TGM-148 itself.

The information gathered from this study is really important. It helps scientists understand if TGM-148 is safe enough to move on to further testing in larger groups of people, potentially those with specific medical conditions. It’s a vital step in developing new medicines, ensuring they are thoroughly checked for safety and how they work before being used more widely.

Key takeaways

This is a first-time-in-humans study for a new treatment called TGM-148.
The main goals are to check the treatment's safety and how the body reacts to it.
Participants will be healthy adults aged 18-45.
You might receive the new treatment or a 'dummy' (placebo) injection.
Your participation helps advance medical research, but offers no direct personal health benefits.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for healthy adults between the ages of 18 and 45. You would need to be in good general health and able to give your full agreement to take part after understanding all the details. Your body weight and height would also need to be within a healthy range, typically a Body Mass Index (BMI) between 18 and 30, and weighing more than 50kg.

There are also some reasons why you might not be able to join. For example, if you have any serious medical conditions or abnormal blood test results that the study doctor thinks could make it unsafe for you to participate or affect the study's results. You also couldn't take part if you've recently been involved in another research study or if you're taking any medications that conflict with the study's rules.

The study doctor will carry out a thorough check to make sure it's safe and suitable for you to take part. This ensures the well-being of all participants and the accuracy of the study's findings.

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 between 18 and 45 years old?
Are you generally healthy and don't have any serious medical conditions?
Do you have a Body Mass Index (BMI) between 18 and 30 and weigh more than 50kg?
Are you able to provide your full consent to take part after understanding the study?
Have you avoided other research studies recently?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit to check if you're suitable for the study. This will involve a medical check-up, blood tests, and other assessments.

If you're eligible, you'll be admitted to a clinic for a short stay (the exact length will be explained). During this time, you'll receive a single dose of either TGM-148 or the placebo via an injection just under the skin. You won't know which one you're getting, and neither will most of the study staff.

After receiving the dose, the medical team will monitor you closely. They'll take regular blood and urine samples, check your vital signs (like blood pressure and heart rate), and ask you about how you're feeling. You'll then have several follow-up visits or calls over a period of time to ensure everything is well and to gather all necessary information. The total duration of your involvement, from the first screening to the last follow-up, will be clearly explained to you.

Potential risks and benefits

Taking part in any research study carries potential benefits and risks. For this study, there are no direct health benefits expected for you, as its main purpose is to gather information about the new treatment's safety and how it works in the body. However, your participation will contribute valuable information that could help develop future medicines for others. Potential risks could include side effects from the study treatment (which might be TGM-148 or the placebo), discomfort from injections or blood draws, or potential unforeseen reactions. All known risks will be fully explained before you agree to take part. It's very important to remember that joining is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (1)

Hammersmith Medicines Research
Verified postcode
London, United Kingdom

Common questions

What is a 'Phase 1' study?

It's the very first stage of testing a new treatment in people. The main aim is to check if it's safe and how the body handles it, not to treat a specific illness yet.

What does 'healthy participants' mean?

It means we're looking for people who generally feel well and don't have any serious ongoing health problems that could affect the study results or make it unsafe for them to take part.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks exactly like the real medicine but contains no active ingredients. It helps researchers compare the effects of the actual treatment more accurately.

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

No, you won't know, and for most of the study, the doctors and nurses won't know either. This is called 'double-masked' and helps make the study results fair and unbiased.

How will the treatment be given?

The treatment will be given as a single injection just under your skin, similar to some common vaccines.

How to find out more

Sponsor Clinical Trials Office

clinicaltrials@tangramtx.com +44 20 4558 3826 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.