Recruiting

Safety and Tolerability of CTX-187 in Healthy Adults and Patients with Bacterial Infection

Study Aim

This phase 1 study aims to evaluate the safety and tolerability of CTX-187 in healthy adults and patients with bacterial infection, by monitoring treatment-emergent adverse events including clinically significant abnormalities in electrocardiograms (ECGs), vital signs, clinical laboratory values, and physical examination.

What is being tested

CTX-187

+ Placebo

+ CTX-187

Drug

Who is being recruted

Bacterial Infections and Mycoses+5

+ Bronchial Diseases

+ Infections

From 18 to 65 Years

+17 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Basic Science Study

Placebo-ControlledPhase 1

Interventional

Study Start: June 2026

See protocol details

Summary

Principal SponsorCentauri Therapeutics Limited

Study ContactCentauri Clinical Team

Last updated: July 16, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: June 16, 2026

Actual date on which the first participant was enrolled.

This is a first-in-human, phase 1 clinical trial. It aims to evaluate the safety and tolerability of a new drug called CTX-187. The study involves healthy adult males and females, as well as individuals with a specific type of bacterial infection known as bronchiectasis, who are chronically infected with a bacterium called P. aeruginosa. The main goal is to understand how the body responds to this new drug, which could potentially help improve treatment options for bacterial infections. During the trial, participants receive CTX-187 through an intravenous (IV) infusion, with doses gradually increasing. The study measures the number of participants who experience treatment-emergent adverse events (TEAEs). These are any unfavorable signs, symptoms, or diseases that occur or worsen during the treatment. They can include significant abnormalities in heart readings (ECGs), vital signs, laboratory test results, and physical examinations.

NCT07708116

Principal SponsorCentauri Therapeutics Limited

Study ContactCentauri Clinical Team

Last updated: July 16, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

104 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Bacterial Infections and MycosesBronchial DiseasesInfectionsRespiratory Tract DiseasesGram-Negative Bacterial InfectionsBacterial InfectionsBronchiectasisPseudomonas Infections

Criteria

7 inclusion criteria required to participate

Part C: Adult males and/or females, 18 to 75 years of age

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: Prior clinical and computerized tomography diagnosis of bronchiectasis

Part C: Otherwise in good physical and mental health without clinically significant abnormalities

Show More Criteria

10 exclusion criteria prevent from participating

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: 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: Known hypersensitivity to any reagents contained in CTX-187 or documented hypersensitivity reaction or anaphylaxis to any medication

Parts A and B: Previous participation in the current trial

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

6 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

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

Group II

Placebo

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

Group III

Experimental

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

Group IV

Placebo

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

Group 5

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.

Group 6

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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

ICON Clinic, location GRQM

Groningen, NetherlandsOpen ICON Clinic, location GRQM in Google Maps

Recruiting

One Study Center