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

July 13, 2026 updated by: Centauri Therapeutics Limited

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to Day 28
TEAEs include clinically significant abnormalities in electrocardiograms (ECGs), vital signs, clinical laboratory values and physical examination.
Up to Day 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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
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
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
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
Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centauri Therapeutics Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 16, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTX-187-101
  • 224842/Z/21/Z (Other Grant/Funding Number: Wellcome Trust)
  • Agmt dtd 1/30/2023 (Other Grant/Funding Number: Germany's Federal Ministry of Education and Research)
  • NNF23SA0088536 (Other Identifier: 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)
  • 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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