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| ID | Type | Description | Link |
|---|---|---|---|
| 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 | EU Trial (CTIS) Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A (Single Ascending Dose [SAD]): CTX-187 | Experimental | Healthy participants will receive a single IV infusion of CTX-187 in escalating doses. |
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| Part A (SAD): Placebo | Placebo Comparator | Healthy participants will receive a single IV infusion of matching placebo. |
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| 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. |
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| Part B (MAD): Placebo | Placebo Comparator | Healthy participants will receive matching placebo via IV infusion BID for 7 days. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo will be administered via IV infusion. |
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| 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 |
| Measure | Description | 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 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Centauri Clinical Team | Contact | Please use email | clinical@centauritherapeutics.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Clinic, location GRQM | Recruiting | Groningen | 9728 | Netherlands |
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| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| D001987 | Bronchiectasis |
| D011552 | Pseudomonas Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
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| 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. |
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| CTX-187 | Drug | CTX-187 will be administered via IV infusion. |
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| 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 |
| D016905 | Gram-Negative Bacterial Infections |