Status:
COMPLETED
Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-EBOMAB092-00-AB (MAb114), Administered Intravenously to Healthy Adults
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Healthy Adult Immune Responses to Vaccine
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 d...
Detailed Description
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 Stu...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- A volunteer must meet all of the following criteria:
- Able and willing to complete the informed consent process.
- Available for clinical follow-up through the last study visit.
- 18 to 60 years of age.
- In good general health without clinically significant medical history.
- Willing to have blood samples collected, stored indefinitely, and used for research purposes.
- Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
- Physical examination without clinically significant findings within the 84 days prior to enrollment.
- Have screening laboratory values within 84 days prior to enrollment that meet the following criteria:
- White Blood Cell (WBC) 2,500-12,000/mm\^3
- WBC differential either within institutional normal range or accompanied by the Principal Investigator (PI) or designee approval
- Platelets = 125,000 - 400,000/mm\^3
- Hemoglobin within institutional normal range or accompanied by the PI or designee approval
- Creatinine less than or equal to 1.1 x upper limit of normal (ULN)
- Alanine aminotransferase (ALT) less than or equal to 1.25 x ULN
- Negative for human immunodeficiency virus (HIV) infection by a Food and Drug Administration (FDA) approved method of detection
- Negative for Hepatitis B core antibody (HBcAb) and Hepatitis C virus antibody (HCV Ab)
- Criteria applicable to women of childbearing potential:
- If a woman is of reproductive potential and sexually active with a male partner, then she agrees to use an effective means of birth control from the time of study enrollment until the last study visit, or to be monogamous with a partner who has had a vasectomy.
- Negative human chorionic gonadotropin (beta-HCG) pregnancy test (urine or serum) on day of enrollment and product administration.
- EXCLUSION CRITERIA:
- A volunteer will be excluded from study participation if one or more of the following conditions apply:
- Previous receipt of a licensed or investigational monoclonal antibody or Ebola vaccine.
- Weight \>100 kg.
- Any history of a severe allergic reaction with generalized urticaria, angioedema or anaphylaxis prior to enrollment that has a reasonable risk of recurrence during the study.
- Hypertension that is not well controlled.
- Woman who is breast-feeding, or planning to become pregnant during study participation.
- Receipt of any investigational study product within 28 days prior to enrollment.
- Any other chronic or clinically significant medical condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer, including but not limited to: diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of: drug or alcohol abuse, asthma, autoimmune disease, psychiatric disorders, heart disease, or cancer.
- Bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with intramuscular (IM) injections or blood draws.
- Use of angiotensin-converting enzyme (ACE) inhibitors or other potential nephrotoxins.
Exclusion
Key Trial Info
Start Date :
May 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 20 2019
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03478891
Start Date
May 16 2018
End Date
March 20 2019
Last Update
October 26 2020
Active Locations (1)
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1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892