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===Phase 1 Study: First Human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers=== | ===Phase 1 Study: First Human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers=== | ||
The first study is conducted in healthy 42 volunteers, 10s of which received saline placebo as control group.<ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers/>. Single, escalating doses of ch-mAb7F9 over the range of 0.2 to 20mg/kg (5 dose groups) were administered and followed for 147 d for pharmacokinetic and immugenicity studies<ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers"/>. No serious adverse reactions or discontinuations form the study due to adverse events<ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers"/>. No trends emerged of adverse events<ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers"/>. Half life of 17-19 d in the 3 highest does groups an volume of distribution of 5-6L suggesting antibody is confined primarily to the vascular compartment<ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers"/>. | The first study is conducted in healthy 42 volunteers, 10s of which received saline placebo as control group.<ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers"/>. Single, escalating doses of ch-mAb7F9 over the range of 0.2 to 20mg/kg (5 dose groups) were administered and followed for 147 d for pharmacokinetic and immugenicity studies<ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers"/>. No serious adverse reactions or discontinuations form the study due to adverse events<ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers"/>. No trends emerged of adverse events<ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers"/>. Half life of 17-19 d in the 3 highest does groups an volume of distribution of 5-6L suggesting antibody is confined primarily to the vascular compartment<ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers"/>. | ||
Serum ch-mAb7F9 concentration is plotted and reported for 147 d<ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers"/>. | Serum ch-mAb7F9 concentration is plotted and reported for 147 d<ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers"/>. | ||
Most common AE include: increased blood creatine phosphokinase, upper respiratory tract infection, decreased hemoglobin, headache, increased aspartate aminotransferase and alanine aminotransferase, proteinuria, decreased white blood cell count, and nasal congestion<ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers"/>. AEs considered by the investigator to be related to study medication were limited to single events in the 2mg/kg group <ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers"/>and included infusion reaction, bronchospasm, and proteinuria<ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers"/>. The 3 Grade 4 AEs(life-threatening) were all elevations in blood creatine phosphokinases levels and were considered unrelated to the ch-mAb and resolved without treatment. 6 events as Grade 3 and 47 grade 2 and 160 events as grade 1 (mild)<ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers"/>. | Most common AE include: increased blood creatine phosphokinase, upper respiratory tract infection, decreased hemoglobin, headache, increased aspartate aminotransferase and alanine aminotransferase, proteinuria, decreased white blood cell count, and nasal congestion<ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers"/>. AEs considered by the investigator to be related to study medication were limited to single events in the 2mg/kg group <ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers"/>and included infusion reaction, bronchospasm, and proteinuria<ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers"/>. The 3 Grade 4 AEs(life-threatening) were all elevations in blood creatine phosphokinases levels and were considered unrelated to the ch-mAb and resolved without treatment. 6 events as Grade 3 and 47 grade 2 and 160 events as grade 1 (mild)<ref name="First human study of a chimeric anti-methamphetamine monoclonal antibody in healthy volunteers"/>. |