drugset / Trial / NCT02724085
A Phase 1 Study to Assess the Safety, Tolerability and PK of IV TP-271
Phase 1
Completed
57 enrolled
Tetraphase Pharmaceuticals, Inc
National Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedParallel-groupQuadruple-blindBasic science
Summary
This is a single-center, randomized, placebo-controlled, double-blind, single-ascending-dose, inpatient study to assess the safety, tolerability, and pharmacokinetics of TP-271 in healthy subjects. Subjects aged 18 to 50 years who fulfill the inclusion/exclusion criteria will be enrolled in this study.
Timeline
- Start
- 2015-12-18
- Primary completion
- 2016-09-28
- Completion
- 2016-12-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | TP-271 | Small molecule | 0.15 mg/kg | Intravenous |
| Comparator | TP-271 | Small molecule | 0.45 mg/kg | Intravenous |
| Comparator | TP-271 | Small molecule | 1 mg/kg | Intravenous |
| Comparator | TP-271 | Small molecule | 2 mg/kg | Intravenous |
| Comparator | TP-271 | Small molecule | 3 mg/kg | Intravenous |
| Comparator | TP-271 | Small molecule | 4 mg/kg | Intravenous |
| Comparator | TP-271 | Small molecule | 5 mg/kg | Intravenous |