NCT02724085

A Phase 1 Study to Assess the Safety, Tolerability and PK of IV TP-271

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Single-Ascending-Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of Intravenous TP-271 in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: Tetraphase Pharmaceuticals, Inc · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

Up to seven cohorts of eight subjects each (up to a total of 56 subjects) will be enrolled. The eight subjects within each cohort will be randomized 6:2 to receive a single intravenous dose of TP-271 or placebo. The planned doses are: Cohort A: 0.15 mg/kg Cohort B: 0.45 mg/kg Cohort C: 1.0 mg/kg Cohort D: 2.0 mg/kg Cohort E: 3.0 mg/kg Cohort F: 4.0 mg/kg Cohort G: 5.0 mg/kg Doses of IMP will be administered intravenously on the morning of Day 1 following an overnight fast (minimum 8 hours). During the Screening Period (within the 28 days prior to the subject receiving TP-271 or placebo) each subject will be assessed for eligibility. Each subject must sign and date an ICF prior to undergoing any study-related procedures. All cohorts will follow the same study design (Figure 1). On Day -1, subjects will be admitted to the study unit so their eligibility can be confirmed. Subjects will be required to stay overnight at the study unit on Day -1. On Day 1, eligible subjects will be enrolled and randomized to receive either TP-271 or placebo. Subjects will be required to stay at the study unit from Day 1 through Day 5 to assess safety and obtain required PK samples. On Day 5, subjects will be discharged from the study unit. A final safety assessment will be performed once between Day 7 and Day 10 following the subject's dose of IMP.

Conditions

• Pneumonia

Interventions

Type	Name	Description
DRUG	TP-271	TP-271 is a novel, broad-spectrum tetracycline with potent activity against multidrug-resistant pathogens. It will be administered intravenously (IV) in doses ranging from 0.15 to 5.0 mg/kg

Timeline

• Start date: 2015-12-18
• Primary completion: 2016-09-28
• Completion: 2016-12-12
• First posted: 2016-03-31
• Last updated: 2021-12-13

Locations

1 site across 1 country: United States