VRC 611
Status:Ongoing
Phase:I
Principal Investigator(s):Seemal F Awan
Objective:VRC 611: A Phase 1 Safety and Pharmacokinetic Study to Evaluate a Human Monoclonal Antibody (mAb) VRC-HIVMAB0102-00-AB (CAP256V2LS) Administered Via Subcutaneous and Intravenous Injection in Healthy Adults
This open-label study will evaluate CAP256V2LS (VRC-HIVMAB0102-00-AB) in healthy adults. The primary hypothesis is that subcutaneous (SC) and intravenous (IV) administrations of CAP256V2LS will be safe and well-tolerated in healthy adults. A secondary hypothesis is that CAP256V2LS will be detectable in human sera with a definable half-life.
Last updated September 19, 2022
Prevention Option(s):Antibody Related Research
Study Design:Open label
Arms and Assigned Interventions
Description5 mg/kg IV
Biological: VRC-HIVMAB0102-00-AB
The CAP256V2LS broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo.
Mode of DeliveryIV Infusions
ARMsExperimental
Description5 mg/kg SC
Biological: VRC-HIVMAB0102-00-AB
The CAP256V2LS broadly neutralizing monoclonal antibody (bNAb) targets the V1V2 region of the HIV-1 envelope, is human in origin, and contains two amino acid modifications within the C-terminus of the heavy chain constant region designed to improve antibody half-life in vivo.
Mode of DeliverySubcutaneous
ARMsExperimental
Official Code:
NCT04408963
Trial Sponsors:
NIAID
Start Date
End Date
March 22, 2022
December 15, 2022
Enrollment:20
Age range:
18 Years ↔
60 Years
Population:Cisgender Men