A Phase 1 interventional study of Placebo and CTX-187 in Bronchiectasis Adult, Bronchiectasis With Pseudomonas Aeruginosa Colonization and Bacterial Infections, sponsored by Centauri Therapeutics Limited. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-16.
Sponsored by Centauri Therapeutics Limited · Phase 1, Interventional, and Basic science
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).
584 studies on the registry are indexed under Bacterial Infections; 84 are open to participants now.
This study's planned enrollment of 104 is above the median of 84 across 382 interventional studies indexed under Bacterial Infections.
Browse Bacterial Infections studies →This is the only study on the registry with Centauri Therapeutics Limited as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Healthy participants will receive a single IV infusion of CTX-187 in escalating doses.
Drug: CTX-187
Healthy participants will receive a single IV infusion of matching placebo.
Drug: Placebo
Healthy participants will receive multiple escalating doses of CTX-187 via IV infusion twice daily (BID) for 7 days.
Drug: CTX-187
Healthy participants will receive matching placebo via IV infusion BID for 7 days.
Drug: Placebo
Participants with a bacterial infection will receive multiple escalating doses of CTX-187 via IV infusion BID for 6 days (Days 2 to 7) with a single dose on Day 1 and Day 8.
Drug: CTX-187
Participants with a bacterial infection will receive matching placebo via IV infusion BID for 6 days (Days 2 to 7) with a single dose on Day 1 and Day 8.
Drug: Placebo
Placebo will be administered via IV infusion.
CTX-187 will be administered via IV infusion.
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
TEAEs include clinically significant abnormalities in electrocardiograms (ECGs), vital signs, clinical laboratory values and physical examination.
Time frame: Up to Day 28
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
Plan to share: No
No publications or documents are linked to this record.
Started Jun 2026 (actual). Primary completion is estimated for Dec 2027, 18 months after the start.
Of 52 industry-sponsored phase 1 interventional studies under Bacterial Infections, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 13. This study's planned 18 months is above that.
Counting every sponsor, half of 67 studies reached it within 9 months; a quarter within 4 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
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