Recruiting NCT07708116
First in Human Trial of CTX-187 in Healthy Volunteers and Chronically Infected Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo, CTX-187.
- Who it may be relevant to
- Registry conditions: Bronchiectasis Adult, Bronchiectasis With Pseudomonas Aeruginosa Colonization, Bacterial Infections. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1 First-In-Human, Double-Blind, Single and Multiple Ascending Dose Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravenous Doses of CTX-187 in Healthy Volunteers Followed by Multiple Doses in Patients With a Bacterial Infection
Overview
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).
Interventions
- Drug Placebo
Placebo will be administered via IV infusion. - Drug CTX-187
CTX-187 will be administered via IV infusion.
Primary outcome measures
- Number of Participants with Treatment-emergent Adverse Events (TEAEs) [Time frame: Up to Day 28]
Secondary outcome measures (7)
- Area Under the Concentration-time Curve (AUC) of CTX-187 in Plasma [Time frame: Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9]
- Maximum Observed Plasma Concentration (Cmax) of CTX-187 [Time frame: Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9]
- Time to Attain Maximum Observed Plasma Concentration (tmax) of CTX-187 [Time frame: Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9]
- Terminal Elimination Half-life (t1/2) of CTX-187 in Plasma [Time frame: Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9]
- Clearance (CL) of CTX-187 [Time frame: Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9]
- Volume of Distribution at Steady-state (Vss) of CTX-187 [Time frame: Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9]
- Number of Participants with Antidrug Antibodies (ADA) Against CTX-187 in Serum [Time frame: Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9]
Eligibility criteria
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.
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Basic science
Study locations
Netherlands · 1 center
- ICON Clinic, location GRQM — Groningen
Identifiers
NCT: NCT07708116 · CTX-187-101 · 224842/Z/21/Z · Agmt dtd 1/30/2023 · NNF23SA0088536 · Agmt dtd 5/19/2025 · CP-CA 25-79 · OTA No. 75A50122C00028 · 2026-525619-15-00