CTX-187 first-in-human test in healthy people and people with chronic bronchiectasis and Pseudomonas infection

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1 interventional trial evaluating single and multiple ascending intravenous doses of CTX-187. The study includes two parts with healthy adults and a third part focusing on adults with bronchiectasis who have chronic P. aeruginosa infection. Participants will receive either CTX-187 or placebo and will be monitored for safety, tolerability, and preliminary pharmacokinetics. The trial aims to identify safe dosing ranges and collect initial safety signals in both healthy volunteers and patients. Domestic and international trial results will guide future development in bacterial infections linked to bronchiectasis.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Parts A and B: Healthy adult males and/or females, 18 to 65 years of age.
2. Parts A and B: Body mass index (BMI): ≥18.0 and ≤32.0 kg/m\^2 and weight \>50 kg.
3. Parts A and B: Good physical and mental health without clinically significant abnormalities.
4. Part C: Adult males and/or females, 18 to 75 years of age.
5. Part C: Prior clinical and computerized tomography diagnosis of bronchiectasis.
6. 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.
7. Part C: Otherwise in good physical and mental health without clinically significant abnormalities.

Exclusion Criteria

1. Parts A and B: Previous participation in the current trial.
2. 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.
3. 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.
4. Part C: Known hypersensitivity to any reagents contained in CTX-187 or documented hypersensitivity reaction or anaphylaxis to any medication.
5. 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.
6. 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.
7. Part C: Receipt of anti-pseudomonal antibiotics for an exacerbation during the screening period.
8. 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.
9. Part C: History of known or suspected Clostridioides difficile infection or diarrhoea within one week of recruitment, not resolved during the past 5 days.
10. Part C: Participants with an acute exacerbation of bronchiectasis.

Where it's running

• ICON Clinic, location GRQM
  Groningen, Netherlands Recruiting

Study contacts

• Study coordinator: Centauri Clinical Team
• Email: clinical@centauritherapeutics.com
• Phone: Please use email

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.