drugset / Trial / NCT03234738

A Phase 1 Safety and PK Study of IV TP-271

NCT03234738 ↗

RandomizedSequentialQuadruple-blindOther

Summary

This is a single-center, randomized, placebo-controlled, double-blind, multiple-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
2017-08-16
Primary completion
2018-01-02
Completion
2018-01-02

Drugs

EvaluationDrugModalityDoseRoute
Comparator TP-271 Small molecule 0.5 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 2.5 mg/kg Intravenous
Comparator TP-271 Small molecule 3 mg/kg Intravenous