Bronchiectasis AdultPhase 1NCT07708116
First in Human Trial of CTX-187 in Healthy Volunteers and Chronically Infected Patients
A Phase 1 study testing CTX-187 in people with Bronchiectasis Adult and Bronchiectasis With Pseudomonas Aeruginosa Colonization, run by Centauri Therapeutics Limited at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchiectasis Adult, Bronchiectasis With Pseudomonas Aeruginosa Colonization, Bacterial Infections
- What is being tested?
- CTX-187
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Jun 2026to 31 Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
ICON Clinic, location GRQM
Groningen, 9728
About this study
Official title: 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).
- Conditions
- Bronchiectasis Adult, Bronchiectasis With Pseudomonas Aeruginosa Colonization, Bacterial Infections
- Being tested
- Placebo, CTX-187
- Keywords
- CTX-187, Bronchiectasis, Pseudomonas Aeruginosa, Bacterial Infections
- Medical subject headings
- Bacterial Infections, Bronchiectasis, Pseudomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo will be administered via IV infusion.
CTX-187Drug
CTX-187 will be administered via IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Part A (Single Ascending Dose [SAD]): CTX-187 | Experimental | Healthy participants will receive a single IV infusion of CTX-187 in escalating doses. Receives: Drug: CTX-187 |
| Part A (SAD): Placebo | Placebo comparator | Healthy participants will receive a single IV infusion of matching placebo. Receives: 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. Receives: Drug: CTX-187 |
| Part B (MAD): Placebo | Placebo comparator | Healthy participants will receive matching placebo via IV infusion BID for 7 days. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to Day 28
Secondary outcomes (7)
Area Under the Concentration-time Curve (AUC) of CTX-187 in Plasma
Measured: 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
Measured: 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
Measured: 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
Measured: Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9
Clearance (CL) of CTX-187
Measured: 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
Measured: 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
Measured: Part A: Up to Day 2; Part B: Up to Day 8; Part C: Up to Day 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start16 Jun 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiectasis AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centauri Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07708116
- Sponsor's protocol ID
- CTX-187-101
- Other IDs
- 224842/Z/21/Z, Agmt dtd 1/30/2023, NNF23SA0088536, Agmt dtd 5/19/2025, CP-CA 25-79, OTA No. 75A50122C00028, 2026-525619-15-00
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07708116
- Acronym / sponsor ID
- CTX-187-101
- Conditions
- Bronchiectasis Adult, Bronchiectasis With Pseudomonas Aeruginosa Colonization, Bacterial Infections
- Keywords
- CTX-187, Bronchiectasis, Pseudomonas Aeruginosa, Bacterial Infections
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Centauri Therapeutics LimitedIndustry (pharma, biotech, devices)
- Study start
- 16 Jun 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A (Single Ascending Dose [SAD]): CTX-187 | Experimental | Drug: CTX-187Healthy participants will receive a single IV infusion of CTX-187 in escalating doses. |
| Part A (SAD): Placebo | Placebo comparator | Drug: PlaceboHealthy participants will receive a single IV infusion of matching placebo. |
| Part B (Multiple Ascending Dose [MAD]): CTX-187 | Experimental | Drug: CTX-187Healthy participants will receive multiple escalating doses of CTX-187 via IV infusion twice daily (BID) for 7 days. |
| Part B (MAD): Placebo | Placebo comparator | Drug: PlaceboHealthy participants will receive matching placebo via IV infusion BID for 7 days. |
| Part C (MAD in Participants with a Bacterial Infection): CTX-187 | Experimental | Drug: CTX-187Participants 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. |
| Part C (MAD in Participants with a Bacterial Infection): Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo will be administered via IV infusion. | Drug | Part A (SAD): Placebo, Part B (MAD): Placebo, Part C (MAD in Participants with a Bacterial Infection): Placebo |
| CTX-187CTX-187 will be administered via IV infusion. | Drug | 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 |
Primary outcome
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.
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CTX-187 in people with Bronchiectasis Adult and Bronchiectasis With Pseudomonas Aeruginosa Colonization, run by Centauri Therapeutics Limited at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Centauri Clinical Team (Please use email, clinical@centauritherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-emergent Adverse Events (TEAEs) (time frame: Up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.