Trials Sponsors Conditions Drugs Pricing

Conditions

Ebola Virus Infection

Outcome Measures

Primary Outcomes (1)

Safety and Tolerability of Treatment with TKM-100201
Subjects will be monitored for treatment-emergent and dose-limiting toxicity (DLT). If there are any adverse events (changes from baseline in laboratory parameters, vitals and/or infusion reactions) during these monitoring periods, the Independent Safety Committee, will discuss the dosing of the remaining subjects. Before proceeding to the next dose cohort, the Independent Safety Committee will evaluate whether dose escalation will be permitted based on demonstration of adequate safety and tolerability.
1 month

Secondary Outcomes (1)

Pharmacokinetics - Cmax, Tmax and AUC will be calculated
29 days post infusion

Study Arms (2)

TKM-100201

EXPERIMENTAL

Drug: TKM-100201

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

TKM-100201Drug

IV Infusion

Also known as: TKM-Ebola

TKM-100201

PlaceboDrug

IV infusion

Also known as: Normal Saline

Placebo

Eligibility Criteria

Age18 Years - 50 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Informed of the nature of the study and have agreed to and are able to read, review and sign the informed consent document at screening. The informed consent document will be written in English, therefore the volunteer must have the ability to read and communicate in English.
Able to comply with all protocol-specified visit schedules and requirements.

Sponsors & Collaborators

Arbutus Biopharma Corporation
Industrylead
United States Department of Defense
US federal agencycollaborator

Study Sites (1)

Cetero Research

Fargo, North Dakota, 58104, United States

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, ViralRNA Virus InfectionsVirus DiseasesInfectionsFiloviridae InfectionsMononegavirales Infections

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

Gregory M Haugen, M.D.
Cetero Research, San Antonio
PRINCIPAL INVESTIGATOR

Enrollment

24 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 8, 2011

First Posted

January 26, 2012

Study Start

January 2012

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic or allergic disease at screening or medication for comorbidity which, in dialogue between the Investigator and Medical Monitor would preclude subject participation in the clinical trial.
Reports an uncontrolled psychiatric disorder or neurologic disease or seizure disorder not controlled by medication.
Subject has a history of existing clinically significant cardiovascular disease (for example, uncontrolled hypertension, unstable angina, congestive heart failure or serious cardiac arrhythmias). In addition New York Heart Association Functional Classification Class II or greater will be excluded (see Appendix).
Reports history of coronary heart disease (CHD), CHD-equivalent disease or CHD risk \>20% as designated by the National Cholesterol Education Program Adult Treatment Panel III.
Current diagnosis or known history of liver disease (e.g. acute or chronic hepatitis or liver cirrhosis).
Presence of any clinically significant results from laboratory tests, vital signs assessments and ECGs as judged by the Investigator(s).
Reports receiving any antiviral drugs, investigational drugs, biologics, or devices within 28 days prior to study treatment or planned use during the course of the study.
Reports receiving naturopathic medications, herbal supplements, or lipid lowering therapies within 28 days prior to study treatment of planned use during the course of the study.
Recent treatment with alternative therapies which, in the view of the Investigator(s) or the Medical Monitor, could potentially confound clinical and laboratory assessments.
Demonstrates a marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval \>450 ms)
Reports concomitant use of any medication that prolongs the QT/QTc interval.
Reports a history of additional risk factors for torsades de pointes (e.g. heart failure, hypokalemia, family history of Long QT Syndrome).
When confirmed upon additional testing, demonstrates a reactive screen for hepatitis B surface antigen, hepatitis C antibody, or HIV antibody.
Reports infections requiring antibiotic therapy within 30 days of screening (as determined by the Investigator\[s\]).
Reports a history of Ebola virus exposure.
+11 more criteria

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

TKM-100201

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

TKM-100201

Placebo

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations