AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Comparative bioavailability study of Colistin Cyclops® administered as 3 different doses

This study is testing an inhaled antibiotic called Colistin Cyclops in healthy adult volunteers. Colistin is a strong medicine often used to treat serious chest and lung infections caused by bacteria. In this trial, doctors want to see how the body absorbs and clears three different doses of the medicine. This type of research is called a bioavailability study. Because this is an early Phase 1 study, it does not aim to cure a disease in the participants. Instead, healthy adults aged 18 and over take the medicine so researchers can carefully track how it moves through the bloodstream. Taking part helps scientists understand which dose gives the best balance of safety and effectiveness, helping future patients who need treatment for severe bacterial infections.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

CCDRD Cooperative Clinical Drug Research and Development AG, PureIMS B.V.

Enrolment target

Start

14 Sep 2026

No therapeutic indication in the current bioavailability trial with healthy adult participants.

What is this study about?

Colistin is a powerful antibiotic that doctors rely on to treat severe bacterial infections, particularly in the lungs. Colistin Cyclops is an inhaled dry powder form of this medicine. Inhaling the medicine allows it to go straight to the lungs where it is needed most. Before this medicine can be widely used, doctors need to know exactly how much of it reaches the bloodstream and how quickly the body clears it.

This trial is a 'bioavailability' study. Bioavailability simply means the rate and amount of a drug that gets into your system. In this study, researchers are comparing three different dose levels of Colistin Cyclops. By studying how different amounts behave inside the body, the research team can find the most effective dose that remains safe and gentle on the body.

Because this is an early human pharmacology study (Phase 1), it is carried out with healthy volunteers rather than people who are currently unwell. The information gathered from these volunteers is vital. It creates a clear safety map that will guide doctors on how to prescribe the antibiotic correctly to future patients fighting serious lung illnesses.

Key takeaways

Tests three different doses of an inhaled antibiotic called Colistin Cyclops.
A Phase 1 study looking at how the human body absorbs and clears the medicine.
Open to healthy adult volunteers aged 18 and over.
Requires clinic visits for breathing tests, inhaling the medicine, and regular blood samples.
Participation is entirely voluntary and you can leave at any time.

Who may be eligible?

This study is looking for healthy adult men and women aged 18 and older. Because the purpose of this trial is to see how the medicine acts in a healthy body, you do not need to have any illness or infection to take part.

To join, you must be in good general health. The research team will run standard health checks before you start to make sure taking part is safe for you. People with significant ongoing medical problems, such as chronic kidney disease, severe asthma, or other long-term lung conditions, will likely not be able to join.

Volunteers may also need to avoid taking certain other medicines or supplements before and during the study to make sure nothing interferes with the test results.

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 aged 18 or older.
I consider myself to be in good general health.
I do not have a history of serious kidney or lung disease.
I am comfortable inhaling a powdered medicine.
I am willing to have regular blood tests and attend clinic visits.

Answer every question to see your result.

What does participation involve?

Taking part in this study involves visiting a specialist clinical research clinic. Before anything starts, the trial team will perform health checks, such as checking your blood pressure, taking blood samples, and testing your breathing. If you are eligible, you will be given three different doses of Colistin Cyclops over the course of the study, usually with rest periods in between. You will inhale the medicine using a dry powder inhaler. The medical team will take regular blood and urine samples over several hours to measure how much medicine is in your system. You will also have follow-up visits to check your overall health before finishing the study.

Potential risks and benefits

Because you are joining as a healthy volunteer, there is no direct medical benefit to your personal health, although you may be compensated for your time and travel. Inhaling colistin can sometimes cause mild side effects, such as a tickly cough, throat irritation, or temporary changes in taste. The clinical team will monitor you closely at all times to keep you safe. Joining is completely voluntary, and you have the right to withdraw from the trial at any point without giving a reason.

Locations (1)

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

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Unverified
Bulgaria

Common questions

What does bioavailability mean?

Bioavailability is a medical term that describes how much of a medicine enters your bloodstream and how fast it gets there after you take it.

Do I need to be ill to take part?

No. This study is designed specifically for healthy adult volunteers to test how the body naturally handles the medicine.

How is the medicine given?

Colistin Cyclops is an inhaled dry powder. You will breathe it in through a small, portable inhaler device provided by the study team.

Will I be paid for my time?

Phase 1 studies with healthy volunteers often provide compensation for your time, travel, and inconvenience. The study team can give you exact details.

Can I leave the study if I change my mind?

Yes. You can leave the study at any time, for any reason, and your medical care will never be affected.