NCT03234738

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

A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Multiple 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: 40 (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, 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.

Detailed description

Up to 5 cohorts of 8 subjects each (up to a total of 40 subjects) will be enrolled. The 8 subjects within each cohort will be randomized 6:2 to receive multiple IV doses of TP-271 or placebo. Study drug will be administered IV once daily on the morning of Days 1 through 7 following an overnight fast (minimum 8 hours). The planned doses for study drug for Cohorts A - E are 0.5 mg/kg TP-271 or placebo, 1.0 mg/kg TP-271 or placebo, 2.0 mg/kg TP-271 or placebo, 2.5 mg/kg TP-271 or placebo and 3.0 mg/kg TP-271 or placebo respectively. During the Screening period (Days -28 to -2 prior to the subject receiving TP-271 or placebo), each subject will be assessed for eligibility. Each subject must sign and date the ICF prior to undergoing any study-related procedures. All cohorts will follow the same study design. On Day -1, subjects will be admitted to the study unit and eligibility confirmed. On Day 1, eligible subjects will be enrolled and randomized to receive either TP-271 or placebo and will receive the assigned drug from Days 1 through 7. Subjects will be required to stay at the study unit from Days -1 through 11 to assess safety and obtain the required PK samples. On Day 11, subjects will be discharged from the study unit. A final safety assessment will be performed once between Days 14 and 20, 7 to 13 days following administration of the subject's final dose of study drug. After all 8 subjects in a cohort have completed study procedures through Day 11, the Principal Investigator and the Sponsor's Medical Monitor will evaluate all blinded safety and plasma PK data to determine whether any criteria that would require a meeting of the Safety Monitoring Committee (SMC) are met. If no such criteria are met, the study may proceed to the subsequent cohort at the next higher dose of TP-271 without consulting the SMC.

Conditions

• Bacterial Infections

Interventions

Type	Name	Description
DRUG	TP-271	multiple oral doses of TP-271 or placebo, dosed once daily for 7 days, randomized 3:1, doses escalating as 0.5 mg/kg, 1.0 mg/kg, 2.0 mg/kg, 2.5 mg/kg, and 3.0 mg/kg
DRUG	Placebo	Placebo is sterile 0.45% saline randomized 3:1 to receive

Timeline

• Start date: 2017-08-16
• Primary completion: 2018-01-02
• Completion: 2018-01-02
• First posted: 2017-07-31
• Last updated: 2021-12-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study