MedTrace Logo

Safety and Pharmacokinetics of a Single ZMappTM Administration in Healthy Adult Volunteers

NCT02389192 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2019-12-16

No results posted yet for this study

Summary

Background:

\- Ebola is a virus that can spread quickly and causes serious disease. It is currently causing an outbreak in West Africa. There are no approved treatments for Ebola. ZMappTM is a new drug made of natural infection-fighting substances. Researchers want to see if it can treat Ebola.

Objective:

\- To assess the safety of ZMappTM and how the body processes it. To measure the immune system response to ZMappTM.

Eligibility:

\- Healthy people 18 50 years old.

Design:

* Participants will be screened with a medical history, physical exam, and blood and urine tests. They will have an electrocardiogram (ECG) to measure heart electrical activity. Small pads will be stuck to the arms, legs, and chest.
* Participants will be admitted to the hospital. They will have a physical exam, medication review, and blood samples.
* Two intravenous (IV) lines will be placed into separate arm veins. A needle will be used to guide plastic tubing into the veins. One will be used to take blood samples. The other will be used to give the study drug.
* Participants will be given drugs to help prevent side effects.
* Participants will be given the study drug by IV over 10 12 hours. Participants will be monitored closely and vital signs taken frequently. They may have another ECG.
* Blood samples will be taken before, during, and after the infusion.
* Participants will stay in the hospital 1 or 2 nights after receiving the drug.
* Participants will have several study visits over 90 days after getting the study drug. They will be asked about side effects. They may have a physical exam, and blood may be drawn.

Conditions

  • Healthy

Interventions

DRUG

ZMAPP

ZMappTM, a combination of three mouse/human chimeric monoclonal antibodies (mAbs; c4G6, c2G4, and c13C6-FR1) directed against Ebola virus glycoprotein epitopes

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Richard T Davey, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-03-11
Primary Completion
2017-12-27
Completion
2017-12-27

More Related Trials

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 NCT02389192 on ClinicalTrials.gov