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AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

A Two-part study to learn the amount of polymyxin E1 in the body over time formed after a single inhaled dose of colistimethate sodium (CMS) in healthy adults (Part 1) and after single inhaled and vein-infused doses of CMS in adults with non‑cystic fibrosis bronchiectasis (NCFB) (Part 2)

This early-stage clinical trial looks at how an antibiotic called colistimethate sodium (CMS) behaves in the human body. In the body, CMS turns into an active medicine called polymyxin E1, which helps fight serious bacterial lung infections. The study has two parts. Part 1 involves healthy adult volunteers who will receive a single breathed-in (inhaled) dose. Part 2 involves adults with non-cystic fibrosis bronchiectasis (NCFB), a condition that causes widened airways and frequent chest infections. These participants will receive the drug both as an inhaled dose and through a drip into a vein (intravenous infusion) on separate occasions. Researchers will take blood samples over time to measure the amount of active medicine produced. This helps doctors understand how the body absorbs and clears the drug, which may improve how lung infections are treated in the future.

At a glance

Status
Authorised
Phase
Human Pharmacology (Phase I)- Other
Sponsor
Zambon S.p.A.
Enrolment target
55
Start
17 Aug 2026

What is this study about?

Non-cystic fibrosis bronchiectasis is a long-term lung condition where the airways become widened and scarred. This damage makes it harder for the lungs to clear mucus, creating an environment where bacteria can grow and cause repeated chest infections. To manage these flare-ups and protect lung function, doctors often rely on specialised antibiotics.

One important antibiotic used for difficult-to-treat infections is colistimethate sodium, often shortened to CMS. Once it enters the body, CMS gradually converts into its active form, polymyxin E1, which actively attacks harmful bacteria. This trial is designed to track how much of this active medicine is formed, how quickly it travels through the bloodstream, and how long it stays in the body.

The study is divided into two parts. In the first part, healthy adult volunteers will breathe in a single dose of the medicine to establish a baseline of how the drug behaves. In the second part, adults living with bronchiectasis will receive the medicine in two different ways: once inhaled directly into the lungs and once given through a drip into a vein.

Because this is an early pharmacology (Phase 1) trial, the goal is not to cure lung disease, but rather to gather precise scientific data. By learning how different people process the drug, researchers hope to guide safer and more effective dosing for patients who need it most.

Key takeaways

  • Phase 1 study testing how the body processes the antibiotic colistimethate sodium (CMS).
  • Open to both healthy volunteers (Part 1) and adults with non-cystic fibrosis bronchiectasis (Part 2).
  • Compares the effects of breathing the medicine in versus receiving it through a vein.
  • Involves clinic visits, breathing checks, and regular blood tests to monitor drug levels.
  • Completely voluntary with no changes to your regular medical care if you decide not to take part.

Who may be eligible?

This trial is open to adults aged 18 and older. Because the study is split into two sections, researchers are looking for two distinct groups of participants.

Part 1 is for healthy adult volunteers who do not have chronic lung conditions. Part 2 is specifically for adults who have a confirmed diagnosis of non-cystic fibrosis bronchiectasis.

You cannot take part if you have cystic fibrosis or if you have a known allergy or sensitivity to colistimethate sodium or similar antibiotics. The study doctor will review your medical history and current medications to confirm if it is safe for you to join.

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.

  1. I am aged 18 or older.
  2. I am either in good general health OR diagnosed with non-cystic fibrosis bronchiectasis.
  3. I do not have cystic fibrosis.
  4. I am able to attend clinic visits and have blood tests taken.
  5. I am comfortable breathing in study medicine or having a temporary drip in my vein.
Answer every question to see your result.

What does participation involve?

If you decide to take part, you will attend appointments at a study clinic. Participants will receive the study medicine either by inhaling it using a special breathing device, through a small tube placed into a vein (an intravenous drip), or both on separate days. While at the clinic, you will have regular blood tests taken over several hours so researchers can track drug levels in your body. The medical team will also check your heart rate, blood pressure, and lung function. The study team will provide a clear schedule showing how many visits are needed and how long you will spend at the centre.

Potential risks and benefits

Taking part in an early-stage pharmacology study will not cure your condition, but it provides vital information that could help improve future treatments for people with lung infections. Common side effects from inhaling this type of medicine include coughing, throat irritation, or temporary wheezing, while drips can cause mild discomfort or bruising where the needle is inserted. The clinical team will monitor you closely throughout your visits. Joining is entirely your choice, and you are free to leave the trial at any point without your standard NHS medical care being affected in any way.

Locations (3)

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

Common questions

What is colistimethate sodium (CMS)?

CMS is an antibiotic used to treat serious bacterial infections. In the body, it turns into an active medicine called polymyxin E1, which works by destroying bacteria.

Will taking part cure my bronchiectasis?

No. This is an early-stage study designed to understand how the body handles the medicine, not to provide a cure or long-term treatment.

How is the medicine given?

Depending on which part of the study you join, the medicine is either breathed into the lungs using an inhaler or nebuliser, or given through a drip into a vein.

Why do you need blood samples?

Taking blood samples at set times allows scientists to measure exactly how much active medicine is in your bloodstream and how fast it leaves your body.

Can I leave the study if I change my mind?

Yes. Participation is completely voluntary, and you can withdraw at any time without giving a reason and without affecting your normal healthcare.

How to find out more

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

Discussion

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