Clinical trial NCT05959707: Evaluating the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibodies in Healthy Participants
Official title: A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibodies VRC01.23LS, PGT121.414.LS and PGDM1400LS Administered Via Intravenous Infusion in Adults Without HIV
Conditions: HIV Infections
Summary: Part A:
The purpose of this part is to study how the body's immune system reacts to a lab-made HIV-1 monoclonal antibody against HIV antigen when given in different doses. The study will also evaluate if the antibody is safe to give to people and does not make them too uncomfortable.
Part B:
The purpose of this part is to study how the body's immune system reacts to a combination of lab-made HIV-1 monoclonal antibodies against HIV antigens when given in different doses. The study also wants to see if the way the antibodies are given affects the immune response.
Interventions:
description: VRC01.23LS will be administered IV over approximately 30 to 60 minutes.
name: VRC01.23LS
type: Biological
description: PGT121.414.LS will be administered IV over approximately 30 to 60 minutes.
name: PGT121.414.LS
type: Biological
description: PGDM1400LS will be administered IV over approximately 30 to 60 minutes.
name: PGDM1400LS
type: Biological
Study arms:
design_group_description: VRC01.23LS 5 mg/kg to be administered via intravenous (IV) infusion at Month 0
design_group_title: VRC01.23LS 5 mg/kg
design_group_type: Experimental
design_group_description: VRC01.23LS 20 mg/kg to be administered via IV infusion at Month 0
design_group_title: VRC01.23LS 20 mg/kg
design_group_type: Experimental
design_group_description: VRC01.23LS 40 mg/kg to be administered via IV infusion at Month 0
design_group_title: VRC01.23LS 40 mg/kg
design_group_type: Experimental
design_group_description: VRC01.23LS 5 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kg to be administered via IV infusion sequentially in this order at Month 0 and Month 6
design_group_title: VRC01.23LS 5 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kg
design_group_type: Experimental
design_group_description: VRC01.23LS 20 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kg to be administered via IV infusion sequentially in this order at Month 0 and Month 6
design_group_title: VRC01.23LS 20 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kg
design_group_type: Experimental
design_group_description: VRC01.23LS 20 mg/kg + PGT121.414.LS 20 mg/kg+ PGDM1400LS 20 mg/kg to be administered via IV infusion sequentially in this order at Month 0 and Month 6
design_group_title: VRC01.23LS 20 mg/kg + PGT121.414.LS 20 mg/kg+ PGDM1400LS 20 mg/kg
design_group_type: Experimental
design_group_description: VRC01.23LS 40 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kg to be administered via IV infusion sequentially in this order at Month 0 and Month 6
design_group_title: VRC01.23LS 40 mg/kg + PGT121.414.LS 5 mg/kg + PGDM1400LS 5 mg/kg
design_group_type: Experimental
design_group_description: VRC01.23LS 40 mg/kg + PGT121.414.LS 40 mg/kg + PGDM1400LS 40mg/kg to be administered via IV infusion sequentially in this order at Month 0 and Month 6
design_group_title: VRC01.23LS 40 mg/kg + PGT121.414.LS 40 mg/kg + PGDM1400LS 40mg/kg
design_group_type: Experimental
Sponsor: HIV Vaccine Trials Network
Collaborators: National Institute of Allergy & Infectious Diseases
Drug name mappings:
name: PGT-121
lang: EN
name: PGDM-1400
lang: EN
name: VRCHIVMAB0115-00-AB
lang: EN