VRC 609
Status:Ongoing
Phase:Open Label, I
Principal Investigator(s):Seemal F Awan
Objective:A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRC-HIVMAB091-00-AB (N6LS), Administered Intravenously or Subcutaneously With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20) to Healthy Adults
The experimental product in this study, N6LS, is a human monoclonal antibody. Antibodies are one way that the human body fights infection. Monoclonal means that all the antibodies in the product are the same. N6LS is directed against the HIV virus. There is no HIV in the N6LS study product and you cannot get HIV from this product. This study will be the first time N6LS is tested in humans. It will be given into a vein in your arm (intravenously, IV) or as an injection underneath your skin (subcutaneously, SC). The study will also test N6LS mixed with an enzyme, rHuPH20 (recombinant human hyaluronidase). rHuPH20 increases the spread of fluids injected underneath your skin (subcutaneously, SC) and allows for the rapid delivery of large volume injections that can be given with a single needle. It will be given as a SC infusion using a small needle attached to an infusion pump. Study products will only be given to healthy adults who are not infected with HIV.
Last updated September 18, 2022
Prevention Option(s):Antibody Related Research
Study Design:Non-randomized, Open label
Arms and Assigned Interventions
Description5 mg/kg IV
Biological: VRC-HIVMAB091-00-AB
The N6LS antibody binds to the CD4-binding site of HIV-1 gp120 protein and contains a methionine to leucine (L) and asparagine to serine (S) (M428L/N434S, referred to as (LS) change within the C-terminus of the heavy chain constant region to increase its binding affinity for the neonatal Fc receptor (FcRn).
Mode of DeliveryIV Infusions
ARMsExperimental
Description5 mg/kg SC
Biological: VRC-HIVMAB091-00-AB
The N6LS antibody binds to the CD4-binding site of HIV-1 gp120 protein and contains a methionine to leucine (L) and asparagine to serine (S) (M428L/N434S, referred to as (LS) change within the C-terminus of the heavy chain constant region to increase its binding affinity for the neonatal Fc receptor (FcRn).
Mode of DeliverySubcutaneous
ARMsExperimental
Description20 mg/kg IV
Biological: VRC-HIVMAB091-00-AB
The N6LS antibody binds to the CD4-binding site of HIV-1 gp120 protein and contains a methionine to leucine (L) and asparagine to serine (S) (M428L/N434S, referred to as (LS) change within the C-terminus of the heavy chain constant region to increase its binding affinity for the neonatal Fc receptor (FcRn).
Mode of DeliveryIV Infusions
ARMsExperimental
Description40 mg/kg IV
Biological: VRC-HIVMAB091-00-AB
The N6LS antibody binds to the CD4-binding site of HIV-1 gp120 protein and contains a methionine to leucine (L) and asparagine to serine (S) (M428L/N434S, referred to as (LS) change within the C-terminus of the heavy chain constant region to increase its binding affinity for the neonatal Fc receptor (FcRn).
Mode of DeliveryIV Infusions
ARMsExperimental
Description5 mg/kg SC
Biological: VRC-HIVMAB091-00-AB
The N6LS antibody binds to the CD4-binding site of HIV-1 gp120 protein and contains a methionine to leucine (L) and asparagine to serine (S) (M428L/N434S, referred to as (LS) change within the C-terminus of the heavy chain constant region to increase its binding affinity for the neonatal Fc receptor (FcRn).
Mode of DeliverySubcutaneous
ARMsExperimental
Description20 mg/kg IV
Biological: VRC-HIVMAB091-00-AB
The N6LS antibody binds to the CD4-binding site of HIV-1 gp120 protein and contains a methionine to leucine (L) and asparagine to serine (S) (M428L/N434S, referred to as (LS) change within the C-terminus of the heavy chain constant region to increase its binding affinity for the neonatal Fc receptor (FcRn).
Mode of DeliveryIV Infusions
ARMsExperimental
Description5 mg/kg SC + 2000 U/ml rHuPH20
Biological: VRC-HIVMAB091-00-AB
The N6LS antibody binds to the CD4-binding site of HIV-1 gp120 protein and contains a methionine to leucine (L) and asparagine to serine (S) (M428L/N434S, referred to as (LS) change within the C-terminus of the heavy chain constant region to increase its binding affinity for the neonatal Fc receptor (FcRn).
Biological: EDP
Recombinant human hyaluronidase PH20 (rHuPH20) enzyme optimizes the SC delivery of co-administered therapeutics by depolymerizing hyaluronan (HA) in the extracellular matrix of the SC space that normally serves to restrict bulk fluid flow. rHP40 is the active ingredient in ENHANZETM Drug Product (EDP).
Mode of DeliverySubcutaneous
ARMsExperimental
Official Code:
NCT03538626
Trial Sponsors:
NIAID
Start Date
End Date
June 21, 2018
December 31, 2022
Enrollment:40
Age range:
18 Years ↔
50 Years
Population:Cisgender Men, Cisgender Women