NCT01518881

Safety, Tolerability and Pharmacokinetic First in Human (FIH) Study of Intravenous (IV) TKM-100201 Infusion

A Placebo-Controlled, Single-Blind, Single-Ascending Dose Study With Additional Multiple-Ascending Dose Cohorts to Evaluate the Safety, Tolerability and Pharmacokinetics of TKM-100201 in Healthy Human Volunteers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Arbutus Biopharma Corporation · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a phase 1, single-center, placebo-controlled, single-blind, first-in-human, single-ascending dose study with additional multiple-ascending dose cohorts in healthy male and female volunteers.

Detailed description

A maximum of 56 healthy adult (male and female) subjects will participate in this study, in two stages. In Stage 1, the Single-Ascending Dose (SAD) phase of the study will have up to six cohorts with 4 subjects (3 receiving TKM-100201 and 1 receiving saline placebo) in each cohort. Additional cohorts may be enrolled if a maximum tolerated dose (MTD) is not established after the initial six cohorts. In Stage 2, the Multiple-Ascending Dose (MAD) portion of the study will have up to three cohorts with four subjects (3 receiving TKM-100201 and 1 receiving saline placebo) in each cohort. Additional cohorts may be enrolled if a maximum tolerated dose (MTD) is not established after the initial three cohorts.

Conditions

• Ebola Virus Infection

Interventions

Type	Name	Description
DRUG	TKM-100201	IV Infusion
DRUG	Placebo	IV infusion

Timeline

• Start date: 2012-01-01
• Primary completion: 2012-07-01
• Completion: 2012-07-01
• First posted: 2012-01-26
• Last updated: 2014-01-09

Locations

1 site across 1 country: United States