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drugset / Trial / NCT05959707

Evaluating the Safety, Tolerability, and Pharmacokinetics of Monoclonal Antibodies in Healthy Participants

NCT05959707 ↗

Phase 1 Suspended 77 enrolled HIV Vaccine Trials Network National Institute of Allergy and Infectious Diseases (NIAID) · collab
RandomizedSequentialOpen-labelPrevention

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.

Timeline

Start
2024-08-14
Primary completion
2025-01-14
Completion
2025-01-14

Drugs

EvaluationDrugModalityDoseRoute
Subject PGDM1400LS Monoclonal antibody 5 mg/kg Intravenous
Subject PGDM1400LS Monoclonal antibody 20 mg/kg Intravenous
Subject PGDM1400LS Monoclonal antibody 40 mg/kg Intravenous
Subject PGT121.414.LS Monoclonal antibody 5 mg/kg Intravenous
Subject PGT121.414.LS Monoclonal antibody 20 mg/kg Intravenous
Subject PGT121.414.LS Monoclonal antibody 40 mg/kg Intravenous
Subject VRC01.23LS Monoclonal antibody 5 mg/kg Intravenous
Subject VRC01.23LS Monoclonal antibody 20 mg/kg Intravenous
Subject VRC01.23LS Monoclonal antibody 40 mg/kg Intravenous

Indications

HIV infectious disease