First in Human Trial of CTX-187 in Healthy Volunteers and Chronically Infected Patients

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

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).

Study Overview

• Status: Recruiting
• Conditions: Bacterial Infections; Bronchiectasis Adult; Bronchiectasis With Pseudomonas Aeruginosa Colonization
• Intervention / Treatment: Drug: Placebo; Drug: CTX-187

• Study Type: Interventional
• Enrollment (Estimated): 104
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Centauri Clinical Team; Phone Number: Please use email; Email: clinical@centauritherapeutics.com

Study Locations

• Netherlands
  • Groningen, Netherlands, 9728
    • Recruiting
    • ICON Clinic, location GRQM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A (Single Ascending Dose [SAD]): CTX-187; Healthy participants will receive a single IV infusion of CTX-187 in escalating doses.	Drug: CTX-187; CTX-187 will be administered via IV infusion.
Placebo Comparator: Part A (SAD): Placebo; Healthy participants will receive a single IV infusion of matching placebo.	Drug: Placebo; Placebo will be administered via IV infusion.
Experimental: Part B (Multiple Ascending Dose [MAD]): CTX-187; Healthy participants will receive multiple escalating doses of CTX-187 via IV infusion twice daily (BID) for 7 days.	Drug: CTX-187; CTX-187 will be administered via IV infusion.
Placebo Comparator: Part B (MAD): Placebo; Healthy participants will receive matching placebo via IV infusion BID for 7 days.	Drug: Placebo; Placebo will be administered via IV infusion.
Experimental: Part C (MAD in Participants with a Bacterial Infection): CTX-187; 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; CTX-187 will be administered via IV infusion.
Placebo Comparator: Part C (MAD in Participants with a Bacterial Infection): Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to Day 28

Secondary Outcome Measures

Outcome Measure	Time Frame
Area Under the Concentration-time Curve (AUC) of CTX-187 in Plasma	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	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	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	Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9
Clearance (CL) of CTX-187	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	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	Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9

Collaborators and Investigators

• Sponsor: Centauri Therapeutics Limited

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 13, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 13, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Bacterial Infections; Bronchiectasis; Pseudomonas Aeruginosa; CTX-187
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Diseases; Bronchial Diseases; Bacterial Infections and Mycoses; Gram-Negative Bacterial Infections; Bronchiectasis; Bacterial Infections; Pseudomonas Infections
• Other Study ID Numbers: CTX-187-101; 224842/Z/21/Z (Other Grant/Funding Number: Wellcome Trust); Agmt dtd 1/30/2023 (Other Grant/Funding Number: The Federal Ministry of Research, Technology, and Space (BMFTR)); NNF23SA0088536 (Other Grant/Funding Number: The Novo Nordisk Foundation (NNF)); Agmt dtd 5/19/2025 (Other Grant/Funding Number: The Ministry of Economy and Finance of Italy); CP-CA 25-79 (Other Grant/Funding Number: EU/DG HERA/KfW Development Bank Award); OTA No. 75A50122C00028 (Other Grant/Funding Number: HHS/BARDA); 2026-525619-15-00 (Ctis)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No