Phase 1 Randomized, Double-Blind, Placebo-Controlled Study of RG7667, an Anticytomegalovirus Combination Monoclonal Antibody Therapy, in Healthy Adults
Ishida JH, Burgess T, Derby MA, Brown PA, Maia M, Deng R, Emu B, Feierbach B, Fouts AE, Liao XC, Tavel JA. Phase 1 Randomized, Double-Blind, Placebo-Controlled Study of RG7667, an Anticytomegalovirus Combination Monoclonal Antibody Therapy, in Healthy Adults. Antimicrobial Agents And Chemotherapy 2015, 59: 4919-4929. PMID: 26055360, PMCID: PMC4505204, DOI: 10.1128/aac.00523-15.Peer-Reviewed Original ResearchConceptsHealthy adultsPlacebo groupAdverse eventsMonoclonal antibodiesDose-proportional pharmacokineticsMost adverse eventsDose-escalation studyMonoclonal antibody therapyProportion of subjectsHuman monoclonal antibodyOverall pharmacokinetic profileLife-threatening diseasePhase 1Transplant recipientsCytomegalovirus infectionAntibody therapyImmunogenicity profileMultiple dosesAntibody responseImmunocompromised individualsPharmacokinetic profileSusceptible populationAdultsHost targetsTherapy