VRC01.23LS / National Institute of Allergy and Infectious Diseases - LARVOL DELTA

A Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRCHIVMAB0115-00-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults (clinicaltrials.gov) - P1 | N=23 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed | N=40 ➔ 23 | Trial completion date: Oct 2025 ➔ Jul 2024 | Trial primary completion date: Oct 2024 ➔ Jul 2024

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

Potent and broadly neutralizing HIV-1 antibodies with improved pharmacokinetics achieved by negative supercharging (AIDS 2024) - "While confirmation is needed regarding whether the enhanced potency observed in in vitro pseudovirus assays translates to improved protection in non-human primates, the conservation of the CH1 and CL domains in IgG1 suggests that these substitutions in the CH1 and CL, along with the addition of acidic tails, have the potential to enhance the PK and potency of various therapeutic antibodies."

Late-breaking abstract • PK/PD data • Human Immunodeficiency Virus • Infectious Disease

HVTN143: Evaluating the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibodies in Healthy Participants (clinicaltrials.gov) - P1 | N=77 | Suspended | Sponsor: HIV Vaccine Trials Network | Not yet recruiting ➔ Suspended

Trial suspension • Human Immunodeficiency Virus • Infectious Disease

HVTN143: Evaluating the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibodies in Healthy Participants (clinicaltrials.gov) - P1 | N=77 | Not yet recruiting | Sponsor: HIV Vaccine Trials Network | Initiation date: Oct 2023 ➔ Apr 2024

Trial initiation date • Human Immunodeficiency Virus • Infectious Disease

A Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRCHIVMAB0115-00-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Active, not recruiting

Enrollment closed • Human Immunodeficiency Virus • Infectious Disease

A Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRCHIVMAB0115-00-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

HVTN143: Evaluating the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibodies in Healthy Participants (clinicaltrials.gov) - P1 | N=77 | Not yet recruiting | Sponsor: HIV Vaccine Trials Network

New P1 trial • Human Immunodeficiency Virus • Infectious Disease

A Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRCHIVMAB0115-00-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults (clinicaltrials.gov) - P1 | N=40 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

New P1 trial • Human Immunodeficiency Virus • Infectious Disease