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P1112 / Monoclonal Antibody PK Study
Open-Label, Dose-Escalating, Phase I Study to Determine Safety and
Pharmacokinetic Parameters of Subcutaneous (SC) VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants
Pharmacokinetic Parameters of Subcutaneous (SC) VRC01, VRC01LS, and VRC07-523LS, Potent Anti-HIV Neutralizing Monoclonal Antibodies, in HIV-1-Exposed Infants
Study Status
Participants Off Study and Primary Analysis Completed
DAIDS Number
11903
IND Number
113,611
Clinical Trials Link
Primary Protocol Team Members
Summary
IMPAACT P1112 is an open-label, dose-escalating, phase I multicenter trial to determine the safety and pharmacokinetics of VRC01, VRC01LS, and VRC07-523LS when given to HIV-1 exposed infants. VRC01, VRC01LS, and VRC07-523LS are potent anti-HIV neutralizing monoclonal antibodies. The primary objectives of P1112 are to assess the safety and pharmacokinetic profiles of VRC01 (single dose for Dose Groups 1 and 2; monthly doses for Dose Group 3), VRC01LS (one or two doses for Dose Group 4) and VRC07-523LS (one or two doses for Dose Group 5), all administered subcutaneously.
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