NCT03538626View on ClinicalTrials.gov

Phase I, Open-Label, Dose-Escalation Study of a Human Monoclonal Antibody, VRC-HIVMAB091-00-AB (N6LS), Administered Intravenously or Subcutaneously With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20)

PHASE1CompletedINTERVENTIONAL
Enrollment

33

Participants

Timeline

Start Date

June 21, 2018

Primary Completion Date

August 29, 2022

Study Completion Date

August 29, 2022

Conditions
HIV Antibodies
Interventions
BIOLOGICAL

VRC-HIVMAB091-00-AB

N6LS (VRC-HIVMAB091-00-AB) is a human monoclonal antibody targeted to the HIV-1 CD4 binding site.

BIOLOGICAL

rHuPH20

Recombinant human hyaluronidase PH20 (rHuPH20) is the active ingredient of the investigational ENHANZE™ Drug Product (EDP). EDP is a purified preparation of rHuPH20.

Trial Locations (1)

20892

National Institutes of Health Clinical Center, Bethesda

All Listed Sponsors
lead

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

NCT03538626 - Phase I, Open-Label, Dose-Escalation Study of a Human Monoclonal Antibody, VRC-HIVMAB091-00-AB (N6LS), Administered Intravenously or Subcutaneously With or Without Recombinant Human Hyaluronidase PH20 (rHuPH20) | Biotech Hunter | Biotech Hunter