{"id":"W4392735610","doi":"10.1002/acr2.11610","title":"Safety, Tolerability, and Pharmacodynamics of the ADAMTS‐5 Nanobody M6495: Two Phase 1, Single‐Center, Double‐Blind, Randomized, Placebo‐Controlled Studies in Healthy Subjects and Patients With Osteoarthritis","year":2024,"lang":"en","type":"article","venue":"ACR Open Rheumatology","topic":"Osteoarthritis Treatment and Mechanisms","field":"Medicine","cited_by":17,"is_retracted":false,"has_abstract":true,"ca_institutions":"","funders":"Merck KGaA","keywords":"Medicine; Pharmacodynamics; Placebo; Tolerability; Pharmacokinetics; Nausea; Single Center; Osteoarthritis; Adverse effect; Pharmacology; Internal medicine; Gastroenterology; Pathology","routes":{"ca_aff":false,"ca_fund":false,"ca_venue":false,"about_ca":true,"invisible_to_affiliation_only":true},"retraction":null,"screen":null,"direct_labels":[],"prediction":{"model_version":"codex-gemma-dda1882f352a","candidate_categories":["metaepi_narrow"],"consensus_categories":["metaepi_narrow"],"category_scores_codex":[0.003434729,0.002044076,0.007017247,0.001099525,0.0009087456,0.0005417477,0.001243161,0.0008770131,0.00001560156],"category_scores_gemma":[0.006589311,0.00154813,0.0007464941,0.001579625,0.002214293,0.001264206,0.001957906,0.001667988,0.00006494108],"about_ca_system_candidate":false,"about_ca_system_consensus":false,"about_ca_system_score_codex":0.0005478947,"about_ca_system_score_gemma":0.001032289,"about_ca_topic_candidate":false,"about_ca_topic_consensus":false,"about_ca_topic_score_codex":0.0005483707,"about_ca_topic_score_gemma":0.003110762,"domain_scores_codex":[0.9872707,0.002101266,0.003627849,0.002778538,0.001455158,0.002766546],"domain_scores_gemma":[0.9785861,0.01623004,0.001665557,0.001582664,0.0008768848,0.001058774],"domain_codex":null,"domain_gemma":null,"domain_candidate":null,"domain_consensus":null,"study_design_codex":"observational","study_design_gemma":"randomized_trial","study_design_scores_codex":[0.1226226,0.03634087,0.4672699,0.01882938,0.02594125,0.006572784,0.1827975,0.0002485894,0.01289819,0.02565305,0.03847897,0.06234695],"study_design_scores_gemma":[0.9411139,0.01074417,0.0009614408,0.004882067,0.002352672,0.002731719,0.01826939,0.0009010946,0.004214917,0.001892576,0.01171214,0.0002239335],"study_design_candidate":"randomized_trial","study_design_consensus":null,"genre_codex":"empirical","genre_gemma":"empirical","genre_scores_codex":[0.9410518,0.03325176,0.0000638611,0.0004115521,0.002959663,0.01626239,0.0005523246,0.0003097774,0.005136806],"genre_scores_gemma":[0.9803787,0.01173743,0.0007190782,0.0007669134,0.0001518691,0.002078841,0.0005747168,0.0003703652,0.00322202],"genre_candidate":"empirical","genre_consensus":"empirical","teacher_disagreement_score":0.8184913,"threshold_uncertainty_score":0.9992301,"prediction_status":"machine_predicted_unvalidated"},"machine_scores":{"provisional":true,"baseline":true,"maturity_gate_passed":false,"score_opus":0.02458173665412834,"score_gpt":0.3255580279512069,"score_spread":0.3009762912970786,"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."}}