Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-EBOMAB092-00-AB (MAb114), Administered Intravenously to Healthy Adults
VRC 608: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-EBOMAB092-00-AB (MAb114), Administered Intravenously to Healthy Adults
Other study identifiers
Sponsor study identifier
Secondary identifiers
interventional
19
1 country
1
Study Start
May 16, 2018
Actual (reported)Primary Completion
March 20, 2019
Actual (reported)Study Completion
March 20, 2019
Actual (reported)Brief Summary
Background: Ebola is a virus that has infected and killed people mostly in West Africa. There is no treatment or prevention for it, but several drugs are being studied. Researchers want to test the drug MAb114 in healthy people not exposed to Ebola to see whether it can be used for Ebola treatment in people who are infected in the future. This trial will not expose volunteers to the Ebola virus. Objectives: To see if MAb114 is safe and how a person's body responds to it. Eligibility: Healthy adults ages 18-60 who weigh 220.5 pounds or less Design: Participants will be screened under protocol NIH 11-I-0164 with:
- Medical history
- Physical exam
- Blood or urine tests Participants will have a first 8- to10-hour visit. They will get MAb114 by IV infusion. For this, a thin tube will be placed in an arm vein. They may get an IV line in their other arm to collect blood. Blood will be taken many times before and after the infusion. Participants may have a urine test. Participants will get a thermometer to check their temperature for 3 days after they get MAb114. They will record their highest temperature and any symptoms. Participants will have about 14 more study visits over 6 months. At each visit, they will have blood taken and be checked for any health changes. They will talk about how they are feeling and if they have taken any medications. At the end of the 6 months, participants may be invited to take part in another study for follow-up sample collection.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
- Recruitment status
- completed
- Actual enrollment (reported)
- 19 participants
- Study completion date
March 20, 2019
Actual (reported)- Listed locations
- 1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
First Submitted
March 21, 2018
Actual (reported)First Posted
March 27, 2018
Actual (reported)Study Start
May 16, 2018
Actual (reported)Results Posted
October 11, 2018
Actual (reported)Primary Completion
March 20, 2019
Actual (reported)Study Completion
March 20, 2019
Actual (reported)
- Last Updated
- October 26, 2020
- Status Verified
- October 2020
- Results QC Date
- October 9, 2018
- Last Update Submitted
- October 21, 2020