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

NCT01518881 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2014-01-09

No results posted yet for this study

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.

Conditions

  • Ebola Virus Infection

Interventions

DRUG

TKM-100201

IV Infusion

DRUG

Placebo

IV infusion

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Arbutus Biopharma Corporation

    lead INDUSTRY

Principal Investigators

  • Gregory M Haugen, M.D. · Cetero Research, San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01518881 on ClinicalTrials.gov