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This study utilized population pharmacokinetic (PK) modeling to characterize VRC01 PK to guide dosing selection for ongoing phase II clinical trials in pediatric patients. Combining VRC01 PK data from 3 adult and 1 infant clinical trials, a total of 1,475 VRC01 serum concentrations from 100 participants were used in the analysis (40 infants and 60 adults). VRC01 was administered either i.v. or s.c. (1\u201340\u00a0mg\/kg). All infants received s.c. doses as compared with 13% s.c. and 87% i.v. in adults. The data were well\u2010described by a two\u2010compartment model. Clearance was 37% higher in adults with HIV infection and 83% lower in infants than adults. Subcutaneous bioavailability was 55% in adults. Rapid absorption was seen in infants indicating therapeutic levels could be achieved quickly. Monte Carlo simulations were used to determine optimal dosing and demonstrated 40\u00a0mg\/kg s.c. at weeks 0, 2, 6, and 10 would maintain VRC01 levels at the suppressive target concentration of 50\u00a0\u03bcg\/mL for the first 14\u00a0weeks of life in infants. The current analysis provides new insight into differences in monoclonal antibody PK between infants and adults and demonstrates the utility of a population PK approach in informing drug development for infant populations.<\/jats:p>","DOI":"10.1002\/cpt.2026","type":"journal-article","created":{"date-parts":[[2020,8,31]],"date-time":"2020-08-31T18:19:36Z","timestamp":1598897976000},"page":"184-192","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Model Informed Development of VRC01 in Newborn Infants Using a Population Pharmacokinetics Approach"],"prefix":"10.1111","volume":"109","author":[{"given":"Jerry","family":"Li","sequence":"first","affiliation":[{"name":"Schools of Medicine and Skaggs School of Pharmacy University of California San Diego La Jolla California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mina","family":"Nikanjam","sequence":"additional","affiliation":[{"name":"Division 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Allergy and Infectious Diseases National Institutes of Health Bethesda Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Julie E.","family":"Ledgerwood","sequence":"additional","affiliation":[{"name":"Vaccine Research Center National Institute of Allergy and Infectious Diseases National Institutes of Health Bethesda Maryland USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edmund V.","family":"Capparelli","sequence":"additional","affiliation":[{"name":"Schools of Medicine and Skaggs School of Pharmacy University of California San Diego La Jolla California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2020,10,3]]},"reference":[{"key":"e_1_2_9_1_1","unstructured":"World Health Organization Data and 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