{"id":"W2495862253","doi":"10.1182/blood.v126.23.4777.4777","title":"First in Human Single-Ascending Dose Study: Safety, Biomarker, Pharmacokinetics and Exposure-Response Relationships of ALXN1210, a Humanized Monoclonal Antibody to C5, with Marked Half-Life Extension and Potential for Significantly Longer Dosing Intervals","year":2015,"lang":"en","type":"article","venue":"Blood","topic":"Complement system in diseases","field":"Immunology and Microbiology","cited_by":29,"is_retracted":false,"has_abstract":true,"ca_institutions":"inVentiv Health Clinical","funders":"","keywords":"Medicine; Pharmacokinetics; Cmax; Eculizumab; Pharmacodynamics; Pharmacology; Tolerability; Immunogenicity; Internal medicine; Paroxysmal nocturnal hemoglobinuria; Gastroenterology; Placebo; Adverse effect; Atypical hemolytic uremic syndrome; Immunology; Complement system; Antibody; Pathology","routes":{"ca_aff":true,"ca_fund":false,"ca_venue":false,"about_ca":false,"invisible_to_affiliation_only":false},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"metacan-v3-hybrid-931329e0061c","candidate_categories":[],"consensus_categories":[],"category_scores_codex":[0.002290254,0.002450671,0.002242492,0.0004217072,0.0005430665,0.001230889,0.0008706755,0.0017759,0.004003963],"category_scores_gemma":[0.001621345,0.0009136625,0.001199097,0.0002947008,0.001261731,0.00127896,0.0003279318,0.003491607,0.001021735],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.001097826,"about_ca_system_score_gemma":0.001280864,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0007871752,"about_ca_topic_score_gemma":0.001130994,"domain_scores_codex":[0.9990438,0.0003646499,0.00004335715,0.0002502266,0.0001241789,0.0001737337],"domain_scores_gemma":[0.9984317,0.0002573991,0.0003866366,0.000302388,0.0001474002,0.0004745382],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"randomized_trial","study_design_gemma":"nonrandomized_trial","study_design_scores_codex":[0.8063598,0.09434333,0.003874716,0.0003271976,0.000756159,0.0001220932,0.000162425,0.0009481546,0.07011873,0.0001261261,0.001478377,0.02138302],"study_design_scores_gemma":[0.1059403,0.8673328,0.009838385,0.00000951464,0.0003291039,0.0001133496,0.00002978347,0.0007124221,0.01387191,0.0001087383,0.001678409,0.00003524181],"study_design_candidate":"nonrandomized_trial","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9943449,0.0006418069,0.0008372883,0.0001463115,0.0001271264,0.001994522,0.0009412669,0.00007741152,0.000889447],"genre_scores_gemma":[0.991518,0.0003667467,0.001159118,0.00037409,0.0002348522,0.001510993,0.001045653,0.00003095298,0.003759704],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.004003963,"threshold_uncertainty_score":0.01339459,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.0725644227953989,"score_gpt":0.3215063060005928,"score_spread":0.2489418832051939,"validation_status":"score_only:v0-immature-baseline","note":"Baseline scores from an immature model (maturity gate not passed). Scores rank; they never assert a category."}}