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

NCT07708116 | Recruiting Phase 1

• 8 other identifiers: CTX-187-101224842/Z/21/ZAgmt dtd 1/30/2023NNF23SA0088536Agmt dtd 5/19/2025CP-CA 25-79OTA No. 75A50122C000282026-525619-15-00
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Bronchiectasis Adult; Bronchiectasis With Pseudomonas Aeruginosa Colonization; Bacterial Infections

Keywords

CTX-187; Bronchiectasis; Pseudomonas Aeruginosa; Bacterial Infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

Study Arms (6)

Part A (Single Ascending Dose [SAD]): CTX-187

EXPERIMENTAL

Healthy participants will receive a single IV infusion of CTX-187 in escalating doses.

Drug: CTX-187

Part A (SAD): Placebo

PLACEBO COMPARATOR

Healthy participants will receive a single IV infusion of matching placebo.

Drug: Placebo

Part B (Multiple Ascending Dose [MAD]): CTX-187

EXPERIMENTAL

Healthy participants will receive multiple escalating doses of CTX-187 via IV infusion twice daily (BID) for 7 days.

Drug: CTX-187

Part B (MAD): Placebo

PLACEBO COMPARATOR

Healthy participants will receive matching placebo via IV infusion BID for 7 days.

Drug: Placebo

Part C (MAD in Participants with a Bacterial Infection): CTX-187

EXPERIMENTAL

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

Part C (MAD in Participants with a Bacterial Infection): Placebo

PLACEBO COMPARATOR

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

Interventions

Placebo DRUG

Placebo will be administered via IV infusion.

Part A (SAD): Placebo; Part B (MAD): Placebo; Part C (MAD in Participants with a Bacterial Infection): Placebo

CTX-187 DRUG

CTX-187 will be administered via IV infusion.

Part A (Single Ascending Dose [SAD]): CTX-187; Part B (Multiple Ascending Dose [MAD]): CTX-187; Part C (MAD in Participants with a Bacterial Infection): CTX-187

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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.

You may not qualify 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, 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.

Sponsors & Collaborators

• Centauri Therapeutics Limited: lead

Study Sites (1)

ICON Clinic, location GRQM

Groningen, 9728, Netherlands

RECRUITING

MeSH Terms

Conditions

Bacterial Infections; Bronchiectasis; Pseudomonas Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Bronchial Diseases; Respiratory Tract Diseases; Gram-Negative Bacterial Infections

Central Study Contacts

Centauri Clinical Team

CONTACT

Please use email; clinical@centauritherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 16, 2026
• Study Start: June 16, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)