VRC 605: Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB075-00-AB (VRC07-523LS), Administered Intravenously or Subcutaneously to Healthy Adults
Status and phase
Conditions
Treatments
Details and patient eligibility
About
Background:
Human immunodeficiency virus (HIV) is a global health threat. The body uses antibodies to fight infection. VRC07-523LS is an antibody directed against HIV. It may be used to prevent mother-to-child transmission of HIV. It may also prevent sexual transmission of HIV and treat HIV-1 infected people.
Objective:
To test the safety, tolerability, dose, and pharmacokinetics of VRC07-523LS in healthy adults.
Eligibility:
Healthy people ages 18-50
Design:
Participants will be screened with:
Medical history
Physical exam
Blood and urine tests
Participants will be assigned to 1 of 7 groups:
Groups 1-5 will get the drug at 1 visit and then be observed for 24 weeks.
Groups 6 and 7 will get the drug at 1 visit every 12 weeks, for a total of 3 doses over 48 weeks.
Participants will get the drug in 1 of 2 ways:
Infusion into a vein over at least 30 minutes. Participants will have blood tests 1, 3, and 6 hours after the infusion. They will have 1-3 visits during that week. Those in Group 7 will have 4-5 visits in the week after their second and third doses.
Injection into the fatty tissue under the skin. Participants will have blood tests before the injection. They will have 1-3 visits during that week. Those in Group 6 will have 4-5 visits after the second and third doses.
Visits include:
Physical exam
Blood and urine tests
Optional oral swabs to collect saliva
Participants will keep a diary of their temperature and symptoms for 3 days after each dose.
Full description
This is the first study of the VRC-HIVMAB075-00-AB (VRC07-523LS) monoclonal antibody (MAb) in healthy adults. It is a phase 1, dose-escalation study to examine safety, tolerability, dose, and pharmacokinetics of VRC07-523LS. The hypothesis is that VRC07-523LS will be safe for administration to healthy adults by the intravenous (IV) and subcutaneous (SC) routes.
Healthy adults 18-50 years of age will be enrolled. There are 4 open-label, dose escalations of VRC07-523LS from 1 mg/kg IV to 40 mg/kg IV, 1 route escalation from IV to SC, and 2 open-label groups to assess repeat dosing. Groups 1-5 are expected to include 3 subjects and Groups 6-7 are expected to enroll 5 subjects. Subjects will be followed for 24 weeks after the last study product administration.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
- INCLUSION CRITERIA:
A volunteer must meet all of the following criteria:
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Able and willing to complete the informed consent process.
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18 to 50 years of age.
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Based on history and examination, must be in good general health and without history of any of the conditions listed in the exclusion criteria.
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Willing to have blood samples collected, stored indefinitely, and used for research purposes.
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Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
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Willing to adhere to reduced risk sexual behavior during study participation.
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Screening laboratory values within 84 days prior to enrollment must 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.
- 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.
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Negative for HIV infection by the FDA approved method of detection.
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Female-Specific Criteria:
- 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 Beta-HCG (human chorionic gonadotropin) pregnancy test (urine or serum) on day of enrollment for women presumed to be of reproductive potential.
EXCLUSION CRITERIA:
A volunteer will be excluded if one or more of the following conditions apply:
- Previous receipt of licensed or investigational monoclonal antibody.
- Weight >115 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 the study participation.
- Receipt of any investigational study agent 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
26 participants in 7 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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