NCT02041715

Safety, Tolerability and Pharmacokinetic First in Human (FIH) Study for Intravenous (IV) TKM-100802

A Placebo-Controlled, Single-Blind, Single-Ascending Dose Study With An Additional Multiple-Dose Cohort to Evaluate the Safety, Tolerability, and Pharmacokinetics of TKM-100802 in Healthy Human Volunteers

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Arbutus Biopharma Corporation · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Phase 1, single-center, placebo-controlled, single-blind, first-in-human, single ascending dose (SAD) study followed by a multiple-dose cohort in healthy male and female subjects.

Detailed description

Approximately 20 male and female healthy adult subjects, 18 to 50 years of age at the time of dosing, will participate in this study. The SAD phase of the study is planned to have up to 4 cohorts with 4 subjects (3 receiving TKM-100802 and 1 receiving saline) in each cohort. Additional cohorts may be enrolled in the SAD phase if a MTD is not established after the initial 4 cohorts. In the multiple-dose phase, one cohort is planned with 4 subjects (3 receiving TKM-100802 and 1 receiving saline) at a maximum dose of 0.24 mg/kg TKM-100802.

Conditions

• Ebola Virus Infection

Interventions

Type	Name	Description
DRUG	TKM-100802 for Injection	IV infusion
DRUG	Placebo	IV infusion

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-07-01
• Completion: 2015-07-01
• First posted: 2014-01-22
• Last updated: 2015-08-07

Locations

1 site across 1 country: United States