2017
Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of RG7667, a Combination Monoclonal Antibody, for Prevention of Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients
Ishida JH, Patel A, Mehta AK, Gatault P, McBride JM, Burgess T, Derby MA, Snydman DR, Emu B, Feierbach B, Fouts AE, Maia M, Deng R, Rosenberger CM, Gennaro LA, Striano NS, Liao XC, Tavel JA. Phase 2 Randomized, Double-Blind, Placebo-Controlled Trial of RG7667, a Combination Monoclonal Antibody, for Prevention of Cytomegalovirus Infection in High-Risk Kidney Transplant Recipients. Antimicrobial Agents And Chemotherapy 2017, 61: 10.1128/aac.01794-16. PMID: 27872061, PMCID: PMC5278717, DOI: 10.1128/aac.01794-16.Peer-Reviewed Original ResearchConceptsHigh-risk kidney transplant recipientsKidney transplant recipientsCMV viremiaTransplant recipientsCMV diseaseCMV infectionCytomegalovirus infectionMonoclonal antibodiesCMV-seronegative recipientsCMV-seropositive donorsLess CMV diseasePlacebo-controlled trialTime of transplantKidney transplantationPlacebo groupAdverse eventsKidney transplantMedian timeSignificant complicationsPlaceboTreatment groupsPatientsViremiaInfectionWeeks
2015
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
2012
Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin α: results of a phase I randomized, placebo-controlled trial
Emu B, Luca D, Offutt C, Grogan JL, Rojkovich B, Williams MB, Tang MT, Xiao J, Lee JH, Davis JC. Safety, pharmacokinetics, and biologic activity of pateclizumab, a novel monoclonal antibody targeting lymphotoxin α: results of a phase I randomized, placebo-controlled trial. Arthritis Research & Therapy 2012, 14: r6. PMID: 22225620, PMCID: PMC3392792, DOI: 10.1186/ar3554.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntibodies, Monoclonal, HumanizedAntirheumatic AgentsArea Under CurveArthritis, RheumatoidChemokine CXCL13DiarrheaDose-Response Relationship, DrugDouble-Blind MethodFemaleHeadacheHumansInjections, IntravenousInjections, SubcutaneousLymphotoxin-alphaMaleMetabolic Clearance RateMiddle AgedSignal TransductionTreatment OutcomeYoung AdultConceptsRA patientsAdverse eventsDose phaseClinical activityBiologic activityMedian Disease Activity ScoreMajority of AEsLymphotoxin αACR70 response ratesActive RA patientsRA disease activityDisease Activity ScorePlacebo-controlled trialSerious adverse eventsRheumatoid arthritis (RA) pathogenesisC-reactive proteinNovel monoclonal antibodyDisease activityPlacebo groupArthritis pathogenesisSerum CXCL13Activity scoreClinical effectsMultiple dosesT cells