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