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| ID | Type | Description | Link |
|---|---|---|---|
| 75A50122C00028 | Other Grant/Funding Number | In part by HHS | |
| 2025-523108-59-00 | EU Trial (CTIS) Number |
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| Name | Class |
|---|---|
| CARB-X (Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator) | UNKNOWN |
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BAL2420 (also known as BAL0302420) is being developed as an antibacterial agent for the treatment of severe infections caused by Gram-negative bacteria. In this study, the sponsor aims to investigate the safety, tolerability and pharmacokinetics (PK) of BAL2420 following administration of single ascending doses (Part A) and multiple ascending doses (Parts B and C) in healthy adult volunteers. In all parts of the study, in each cohort, a different dose of study drug is to be investigated against a matched placebo in a randomized and double-blind manner.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental | A single intravenous (IV) dose of BAL2420 or placebo will be administered to healthy subjects |
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| Part B | Experimental | A daily IV dose of BAL2420 or placebo will be administered multiple times to healthy subjects |
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| Part C | Experimental | A different IV dosing regimen of BAL2420 or placebo will be administered to healthy subjects |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAL2420 or placebo | Drug | Single ascending dose administration (SAD) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants reporting adverse events (AEs) in Part A | From screening until Day 10 | |
| Number of participants with abnormal electrocardiograms QT Interval in Part A | From screening until Day 10 | |
| Number of participants reporting adverse events (AEs) in Part B and C | From screening until Day 14 | |
| Number of participants with abnormal ECG QT Interval in Part B and C | From screening until Day 14 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Kaindl, MD | Contact | +41615671505 | thomas.kaindl@basilea.com |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Kaindl, MD | Basilea Pharmaceutica International Ltd, Allschwil | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Early Clinical & Bioanalytical Solutions | Recruiting | Groningen | 9728 NZ | Netherlands |
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| BAL2420 or placebo |
| Drug |
Multiple-ascending dose (MAD) |
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| BAL2420 or placebo | Drug | MAD |
|