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

NCT02041715 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2015-08-07

No results posted yet for this study

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.

Conditions

  • Ebola Virus Infection

Interventions

DRUG

TKM-100802 for Injection

IV infusion

DRUG

Placebo

IV infusion

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Arbutus Biopharma Corporation

    lead INDUSTRY

Principal Investigators

  • Mark Kowalski, MD, PhD · Arbutus Biopharma Corporation

  • Emanuel DeNoia, MD · ICON Development Solutions

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
2014-01-31
Primary Completion
2015-07-31
Completion
2015-07-31

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 NCT02041715 on ClinicalTrials.gov