AuthorisedHuman Pharmacology (Phase I)- Bioequivalence StudyInterventional

A Phase 1, Randomized, Double-Blind, Two-Arm, Two-Way Crossover Study of Pharmacokinetics and Pharmacodynamics of QL0911

This study, called a Phase 1 trial, is investigating a new medication named QL0911. It's designed to understand how the medicine behaves in the body (pharmacokinetics) and what effects it has (pharmacodynamics). Researchers are looking at its potential for people with Immune Thrombocytopenia, a condition where the body attacks its own blood platelets, leading to easy bruising and bleeding. They are also studying its use for the Hematopoietic Syndrome of Acute Radiation Syndrome, a serious blood-related illness that can happen after significant radiation exposure. This is an early and important step in developing new treatments for these conditions, helping scientists learn more about QL0911's safety and how it works.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Bioequivalence Study

Sponsor

Qilu Pharmaceutical Co. Ltd.

Enrolment target

Start

26 Jan 2026

Immune Thrombocytopenia Hematopoietic Syndrome of Acute Radiation Syndrome

What is this study about?

This study is a very early look at a new medicine called QL0911. Think of it like a first step in helping scientists understand how a new car engine works. Researchers want to find out how the medicine moves through your body after you take it, how quickly it's absorbed, and how long it stays around (this is called pharmacokinetics). They also want to see what effects it has on your body (this is called pharmacodynamics).

The medicine is being explored for two different health problems. One is Immune Thrombocytopenia, often shortened to ITP. This is a condition where your body's immune system mistakenly attacks and destroys your platelets, which are tiny cells in your blood that help it to clot. If you have too few platelets, you can bleed and bruise very easily. The other condition is the Hematopoietic Syndrome of Acute Radiation Syndrome. This is a severe illness that affects your blood-making system if you've been exposed to a lot of radiation, which can happen in very rare but serious accidents.

Because this is a very early, or 'Phase 1', study, it's mainly about safety and understanding the basics of how the medicine works in people. It's not about treating these conditions yet, but gathering crucial information that could lead to new treatments in the future. The results from studies like this are vital for deciding if a medicine is safe enough and promising enough to be tested in larger groups of people later on.

Key takeaways

This is an early-stage study (Phase 1) of a new medicine called QL0911.
It aims to understand how QL0911 works in the body and its initial safety.
The medicine is being explored for Immune Thrombocytopenia and Acute Radiation Syndrome.
Participants will be adults, aged 18 and over, of any sex.
Taking part helps advance medical science, but direct personal benefit is not guaranteed.

Who may be eligible?

To take part in this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

Because more specific details about eligibility weren't provided, researchers will have a set of health checks and other requirements to make sure the study is safe for you and that the results they get are accurate. This usually includes checking your general health, any other medicines you take, and if you have any other medical conditions.

It's important to remember that even if you meet the basic age and sex requirements, there will be other rules to make sure the study is right for you. The study team will discuss all of these with you carefully.

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 of any gender (male or female)?
Are you generally healthy, or do you have one of the conditions being studied?
Are you able to attend regular study visits and follow instructions?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be invited to participate in what's called a 'crossover' study. This means you would receive the study medicine, QL0911, at one time, and then at another time, you would receive either a different dose of QL0911 or a placebo (a dummy medicine with no active ingredients), without you or the doctors knowing which you receive at any given time. This helps researchers compare the effects accurately. You would have several visits to the study clinic or hospital over a period of time. At these visits, doctors and nurses would perform various checks, which might include blood tests, urine tests, physical examinations, and asking you questions about how you're feeling. You would be given the study medicine as instructed. The total duration of your participation, including follow-up, would be fully explained to you before you agree to join.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as contributing to scientific understanding that could lead to new treatments for serious conditions. You would also receive close medical attention and monitoring. However, as with any new medicine, there are potential risks, including experiencing side effects that are currently unknown. The study team will explain all known and potential risks to you. You are free 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.

—
Unverified
Poland

Common questions

What is Immune Thrombocytopenia (ITP)?

ITP is a condition where your body's immune system mistakenly attacks and destroys blood cells called platelets, which help your blood to clot.

What is Acute Radiation Syndrome?

This is a severe illness that can happen if a person is exposed to very high levels of radiation, affecting different parts of the body, including the blood system.

What does 'Phase 1' mean for a study?

Phase 1 studies are the first time a new medicine is tested in people. They focus on whether the medicine is safe and how it works in the body, rather than how well it treats a specific disease yet.

Will I know if I'm getting the actual medicine or a dummy pill?

In this 'double-blind' study, neither you nor the study doctors will know whether you are receiving the active medicine or a placebo (dummy pill) at any given time. This helps make the study results more reliable.

Will taking part help my condition directly?

Because this is an early-stage study, the main goal is to gather information about the medicine. While it's possible you might benefit, it's not guaranteed, and the focus isn't on treating your condition directly at this stage.