Not yet recruitingPHASE2INTERVENTIONAL

Phase 2a Study of the Efficacy and Safety of TRX-100 in a Human Influenza A Challenge Model

Researchers are conducting a study to test a new medicine called TRX-100. The main goal is to find out if TRX-100 can safely and effectively stop healthy adults from getting the flu (specifically, a type called Influenza A) when they are exposed to the virus. Participants will take either TRX-100 or a placebo (a dummy pill) without knowing which one they receive. Afterwards, they will be given a small, controlled dose of the flu virus. This type of study helps us understand if the new medicine could be a good way to protect people from the flu in the future. It’s an early stage study, focusing on how well the medicine works and if it has any side effects.

At a glance

Status

Not yet recruiting

Phase

PHASE2

Sponsor

Traws Pharma, Inc.

Enrolment target

165

Start

01 Jun 2026

Estimated completion

01 Apr 2027

Influenza

What is this study about?

This study is an early-stage clinical trial looking at a new medicine called TRX-100. We're trying to understand if this medicine can help prevent people from getting the flu. The flu can make people feel very unwell, so finding new ways to prevent it is really important. In this study, we're focusing on a specific type of flu called Influenza A.

To see if TRX-100 works, we'll be giving healthy adult volunteers either the new medicine or a 'placebo' – which looks the same but contains no active medicine. Neither the participants nor the doctors will know who gets which, which helps us get fair results. After taking the medicine, participants will be given a small, controlled amount of the flu virus. This is a common way to test flu prevention medicines in a safe environment.

The main aim is to check if TRX-100 can stop people from getting flu symptoms or make their illness milder, and to closely monitor for any side effects. Your participation could help us learn if TRX-100 could be a helpful option for preventing flu in the future.

Key takeaways

This study is testing an early-stage flu prevention medicine called TRX-100.
It aims to see if TRX-100 is safe and effective in preventing Influenza A in healthy adults.
Participants will receive either TRX-100 or a placebo, followed by a small dose of flu virus.
Careful medical checks will monitor your health throughout the study.
Your involvement could help develop new ways to fight the flu.

Who may be eligible?

To join this study, you need to be a healthy adult between 18 and 55 years old. We're looking for individuals who are generally well and don't have any major ongoing health problems.

We'll check your overall health through a medical history, physical exam, and some basic tests like heart traces (ECG) and blood work to make sure it's safe for you to take part. Your weight and body mass index (BMI) also need to be within a certain range.

For women, if you could become pregnant, you'll need to have a negative pregnancy test and agree to use effective birth control during and for a short time after the study. If you're a woman who can't become pregnant (for example, if you've gone through menopause or had certain surgeries), you'll need to confirm that with the study team.

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 55 years old?
Are you generally healthy with no major ongoing medical conditions?
Do you meet the weight and BMI requirements?
If you are a woman who could become pregnant, are you willing to use effective birth control during the study?
Are you able to provide your written consent to participate?

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. If you meet all the criteria, you'll then be given either the TRX-100 medicine or a placebo to take. You won't know which one you receive. Shortly after this, you'll be given a small, controlled amount of the flu virus.

You'll be monitored closely by the study team throughout this period to see how you react and check for any flu symptoms or side effects. This will involve regular check-ups, and the study team will guide you on how long you need to stay in the study. The total duration of your involvement will be clearly explained to you before you agree to participate.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as contributing to scientific understanding and the development of new flu prevention methods. You will also receive careful medical monitoring throughout the study. However, like all clinical trials, there are potential risks. You might experience flu symptoms after being given the virus, or you could have side effects from the investigational medicine. The study team will explain all known or potential risks to you in detail. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without giving a reason, and this will not affect your medical care.

Locations (1)

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

hVIVO Services Limited
Verified postcode
London, United Kingdom

Common questions

What is TRX-100?

TRX-100 is a new medicine being tested to see if it can help prevent the flu.

Will I definitely get the flu in this study?

You will be given a small amount of the flu virus, so there is a chance you could develop flu-like symptoms. You will be closely monitored.

What is a placebo?

A placebo is a 'dummy' medicine that looks like the real thing but doesn't contain any active ingredients. It helps us compare the effects of the new medicine.

How long will I be in the study?

The full duration of your involvement will be thoroughly explained to you during the consent process before you decide to join.

Can I leave the study at any time?

Yes, you are free to leave the study at any point, for any reason, and it won't affect your future medical care.

How to find out more

Ekaterina Dokukina

kdokukina@eilenther.com +38269728309 Official trial record

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