Clinical trialNCT02389192WithdrawnPhase 1Interventional

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

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment0Healthy

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Richard T Davey, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Principal InvestigatorKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

No facility list is in our current data snapshot for this study. The registry record on ClinicalTrials.gov ↗ carries any published locations. Why? →

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

ZMAPP

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 11 Mar 2015
Primary completion: 27 Dec 2017
Completion: 27 Dec 2017
Last update posted: 16 Dec 2019
Registered enrollment: 0
Registry id: NCT02389192

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.