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New treatment option for Bronchiectasis Adult
Official title First in Human Trial of CTX-187 in Healthy Volunteers and Chronically Infected Patients
ClinicalTrials.gov ID: NCT07708116
What this study is testing
What is CTX-187?
CTX-187 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for bronchiectasis adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- 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...
- Part C: Treatment with long term inhaled, systemic or nebulized anti-pseudomonal antibiotics which are newly initiated within the previous 3 months...
See the full eligibility 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...
- Part C: Otherwise in good physical and mental health without clinically significant abnormalities.
- 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...
- 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...
- 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...
- Part C: History of known or suspected Clostridioides difficile infection or diarrhoea within one week of recruitment, not resolved during the past 5 days.
- Part C: Participants with an acute exacerbation of bronchiectasis.
The study team makes the final eligibility decision.
Where it's taking place
- Groningen, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Groningen, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.