AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A Study of PRO-203 in Healthy Volunteers and Participants with Systemic Sclerosis

This early-stage clinical trial is testing a new drug called PRO-203. The main goal is to find out if the treatment is safe, what side effects it might cause, and how the human body processes it. The study is recruiting both healthy volunteers and adults diagnosed with systemic sclerosis. Systemic sclerosis, sometimes called scleroderma, is a rare condition that causes the immune system to attack connective tissue. This can lead to hard, tight skin and problems in blood vessels or internal organs. Because this is a Phase 1 study, the main focus is on safety rather than whether the drug works as a cure. Participants will be closely monitored by a specialist medical team throughout the study with regular health checks, blood tests, and medical examinations.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Prolium Bioscience Inc.

Enrolment target

Start

30 Sep 2026

systemic sclerosis

What is this study about?

Systemic sclerosis, also known as scleroderma, is a long-term condition where the immune system mistakenly attacks healthy tissue under the skin and around internal organs. This causes the body to produce too much collagen, leading to thick, hardened patches of skin, joint stiffness, and sometimes damage to the lungs, heart, or kidneys. Finding gentle, effective treatments can be difficult, which is why scientists are working on new medicines.

This clinical trial is testing a potential new treatment called PRO-203. It is a Phase 1 study, which means it is one of the earliest stages of testing in humans. Before a medicine can be used widely, doctors must carefully test it in small groups of people to make sure it is safe and to understand what dose is best.

The study includes two groups of people: healthy volunteers and people with systemic sclerosis. By studying both groups, doctors can compare how the drug behaves in a typical body versus how it behaves in someone with the condition. Even though this early study will not provide a cure, the results will help researchers decide if PRO-203 could become a helpful treatment in the future.

Key takeaways

Tests an early-stage experimental medicine called PRO-203.
Open to both healthy volunteers and people with systemic sclerosis aged 18 and over.
Mainly focuses on safety and how the body breaks down the medicine.
Requires regular clinic visits for monitoring, blood tests, and heart checks.
Participation is completely voluntary, and you can withdraw at any time.

Who may be eligible?

This trial is looking for men and women aged 18 and older. The study team is looking for two groups of people: healthy volunteers who do not have any serious medical conditions, and people who have a confirmed medical diagnosis of systemic sclerosis.

To keep everyone safe, you will need to go through medical checks before you can join. People who are pregnant, breastfeeding, or have other serious health problems may not be able to take part.

Your general health, medical history, and any regular medicines you take will be carefully reviewed by the trial doctors to confirm if this trial is safe and suitable for you.

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.

I am at least 18 years old.
I am either in good health or have been diagnosed with systemic sclerosis.
I am able and willing to attend all scheduled clinic visits and health checks.
I am comfortable having blood tests and medical monitoring during the study.
I am not currently pregnant or breastfeeding.

Answer every question to see your result.

What does participation involve?

Taking part in this study involves visiting a specialist trial clinic. At the start, the study team will carry out health checks, such as blood tests, heart tracings (ECGs), and blood pressure checks, to confirm you are safe to join. You will then receive the study medicine, PRO-203, and stay at the clinic for monitoring so doctors can see how your body responds. You will need to attend follow-up visits to check your health and test blood samples over a set period. The team will explain the exact schedule and total length of time before you agree to take part.

Potential risks and benefits

Taking part in a Phase 1 trial may not give you any direct health benefits, but your participation helps scientists develop future treatments for systemic sclerosis. As PRO-203 is a new medicine, there is a risk of unexpected side effects, and clinic visits can take up time. The medical team will watch you very closely to manage any risks. Joining is entirely voluntary, and you are free to leave the trial at any point without it affecting your usual NHS 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
Germany

Common questions

What is systemic sclerosis?

It is a rare condition where the body's immune system causes skin and connective tissues to become unusually thick and hard.

What is a Phase 1 clinical trial?

A Phase 1 trial is an early test of a new medicine in a small group of people to check its safety and see how the body handles it.

Why are healthy volunteers needed?

Healthy volunteers help doctors understand how the medicine behaves in a standard body, which gives a clear baseline for comparison.

Will taking part cure my condition?

No. Phase 1 trials are designed to test safety and dosage rather than provide a direct cure for participants.

Can I leave the study if I change my mind?

Yes. You can leave the study at any time, for any reason, without giving an explanation and without losing your standard medical care.