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| ID | Type | Description | Link |
|---|---|---|---|
| 272201600029C-P00007-9999-2 | U.S. NIH Grant/Contract | View source | |
| 17-0004 | Other Identifier | DMID |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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This is a 2-part dose-ranging study to evaluate the safety and pharmacokinetics of escalating doses of VNRX-5024. Subjects will be enrolled in one of three dose cohorts. They will receive a single dose on Day 1 in Part 1 and will proceed into the multiple dose Part 2 of the study after safety assessments and PK samples are collected. In the multiple dose part of the study, subjects will receive multiple doses of VNRX-5024 for 10 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VNRX-5024 | Experimental | Capsule formulation |
|
| Placebo | Placebo Comparator | Placebo for VNRX-5024 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VNRX-5024 | Drug | Part 1: one dose Part 2: Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours [q12h] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours [q8h] dosing for 9 days with a single morning dose on Day 10) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with adverse events | Day 19 |
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: AUC0-tau | Days 1-2 | |
| Part 2: AUC0-tau | Days 3-12 | |
| Part 1: Cmax |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kamal Hamed, MD | Basilea Pharmaceutica International Ltd, Allschwil | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PRA Health Sciences - Early Development Services | Groningen | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40762485 | Derived | Dorr MB, de Oliveira CF, van de Wetering J, Lowe K, Sabato P, Winchell G, Chen H, McGovern PC. Pharmacokinetics and safety of single and repeat doses of ceftibuten in healthy participants: a phase 1 dose escalation study. Antimicrob Agents Chemother. 2025 Sep 3;69(9):e0008725. doi: 10.1128/aac.00087-25. Epub 2025 Aug 5. |
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|
| Placebo for VNRX-5024 | Drug | Part 1: one dose Part 2: Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours [q12h] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours [q8h] dosing for 9 days with a single morning dose on Day 10) |
|
| Days 1-2 |
| Part 2: Cmax | Days 3-12 |
| Part 1: tmax | Days 1-2 |
| Part 2: tmax | Days 3-12 |
| Part 1: CLr | Days 1-2 |
| Part 2: CLr | Days 3-12 |