First in Human Trial of CTX-187 in Healthy Volunteers and Chronically Infected Patients (NCT07708116) | Clinical Trial Compass
RecruitingPhase 1
First in Human Trial of CTX-187 in Healthy Volunteers and Chronically Infected Patients
Netherlands104 participantsStarted 2026-06-16
Plain-language summary
The primary objective of this trial is to assess the safety and tolerability of single and multiple ascending intravenously (IV) infused doses of CTX-187 when administered to healthy adult male and female participants and participants with a bacterial infection (bronchiectasis participants chronically infected with P. aeruginosa).
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Parts A and B: Healthy adult males and/or females, 18 to 65 years of age.
. Parts A and B: Body mass index (BMI): ≥18.0 and ≤32.0 kg/m\^2 and weight \>50 kg.
. Parts A and B: Good physical and mental health without clinically significant abnormalities.
. Part C: Adult males and/or females, 18 to 75 years of age.
. Part C: Prior clinical and computerized tomography diagnosis of bronchiectasis.
. Part C: P. aeruginosa in sputum, bronchoalveolar lavage or another airway sample at least once in the 12 months prior to screening and P. aeruginosa in sputum during screening, both of which should be at least 21 days apart.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
. Part C: Otherwise in good physical and mental health without clinically significant abnormalities.
Exclusion criteria
. Parts A and B: Previous participation in the current trial.
. Parts A and B: History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any acute illness or surgery within the past 3 months determined by the Investigator to be clinically relevant.
. Parts A and B: Participation in a drug trial within the previous 30 days before the first dose of trial drug or 5x elimination half-life, if known, whichever is longer.
. Part C: Known hypersensitivity to any reagents contained in CTX-187 or documented hypersensitivity reaction or anaphylaxis to any medication.
. Parts A, B and C: Known clinical diagnosis of cystic fibrosis, active allergic bronchopulmonary aspergillosis or active tuberculosis or nontuberculous mycobacterial infection; primary diagnosis of asthma or chronic obstructive pulmonary disease.
. Part C: Treatment with long term inhaled, systemic or nebulized anti-pseudomonal antibiotics which are newly initiated within the previous 3 months prior to screening.
. Part C: Receipt of anti-pseudomonal antibiotics for an exacerbation during the screening period.
. Part C: History or presence of unstable co-morbidities: cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any acute illness or surgery within the past 3 months determined by the Investigator to be clinically relevant. Participants on stable doses of anti-hypertensive medications or statins may be included following discussion between the Investigator and the medical monitor.