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This is a randomized, single-blind, placebo-controlled, sequential parallel-group and multiple ascending dose (MAD) study to evaluate the safety, tolerability and pharmacokinetics of KBP 7072 in healthy subjects. The safety will be assessed at each dose level before progressing to the next higher dose.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KBP-7072: Cohort 1 | Experimental | Healthy Volunteers will receive multiple dose of KBP-7072 and placebo |
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| KBP-7072: Cohort 2 | Experimental | Healthy Volunteers will receive multiple dose of KBP-7072 and placebo |
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| KBP-7072: Cohort 3 | Experimental | Healthy Volunteers will receive multiple dose of KBP-7072 and placebo |
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| KBP-7072: Cohort 4 | Experimental | Healthy Volunteers will receive multiple dose of KBP-7072 and placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KBP-7072 | Drug | Drug Intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability (i.e., number of participants with adverse events, abnormal vital signs, clinical laboratory findings, 12-lead ECGs and physical examinations) in healthy subjects | up to 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) in healthy subjects | on Day 1 (first dose): pre-dose (within 30 minutes prior to dosing) and 0.5, 1, 2, 4, 6, 10, 12, 18, and 24 hours post dose; on Days 4, 7, 8, and 9: pre-dose (within 30 minutes prior to dosing); on Day 10 (last dose): pre-dose (within 30 minutes prior to dosing) and 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 48, 72, 96, 120, 144, and 168 hours post dose. | up to 10 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Frontage Laboratories, Inc. | Secaucus | New Jersey | 07094 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32071042 | Derived | Huband MD, Mendes RE, Pfaller MA, Lindley JM, Strand GJ, Benn VJ, Zhang J, Li L, Zhang M, Tan X, Liu Q, Flamm RK. In Vitro Activity of KBP-7072, a Novel Third-Generation Tetracycline, against 531 Recent Geographically Diverse and Molecularly Characterized Acinetobacter baumannii Species Complex Isolates. Antimicrob Agents Chemother. 2020 Apr 21;64(5):e02375-19. doi: 10.1128/AAC.02375-19. Print 2020 Apr 21. |
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| ID | Term |
|---|---|
| C000716167 | kbp-7072 |
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| Placebo | Other |
|