Pharmacodynamics of subcutaneous recombinant human interleukin-10 in healthy volunteers
Interleukin‐10 inhibits T‐lymphocyte activation and proliferation and lipopolysaccharide‐induced monocyte production of proinflammatory cytokines. Fifty‐four healthy volunteers received single doses of recombinant human interleukin‐10 (1.0, 2.5, 5.0, 10, 25, or 50 μg/kg) or placebo by subcutaneous i...
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| Veröffentlicht in: | Clinical pharmacology and therapeutics 1997-08, Vol.62 (2), p.171-180 |
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| creator | Huhn, Richard D. Radwanski, Elaine Gallo, Jose Affrime, Melton B. Sabo, Ron Gonyo, Gerilyn Monge, April Cutler, David L. |
| description | Interleukin‐10 inhibits T‐lymphocyte activation and proliferation and lipopolysaccharide‐induced monocyte production of proinflammatory cytokines. Fifty‐four healthy volunteers received single doses of recombinant human interleukin‐10 (1.0, 2.5, 5.0, 10, 25, or 50 μg/kg) or placebo by subcutaneous injection (randomized double‐blind assignment). Clinical adverse events were infrequent at doses below 50 μg/kg (five of six subjects had mild flu‐like syndrome). Mean serum interleukin‐10 concentrations were dose related. The mean terminal‐phase half‐life ranged from 2.7 to 4.5 hours, and the apparent volume of distribution ranged from 0.70 to 1.35 L/kg. Hematologic changes included transient mild to moderate increases of neutrophil counts, decreases of lymphocyte counts, and a delayed decrease of platelet counts. Recombinant human interleukin‐10 significantly suppressed production of the proinflammatory cytokines interleukin‐1β and tumor necrosis factor‐α by whole blood stimulated ex vivo with Escherichia coli lipopolysaccharide.
Clinical Pharmacology & Therapeutics (1997) 62, 171–180; doi: |
| doi_str_mv | 10.1016/S0009-9236(97)90065-5 |
| format | Article |
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Clinical Pharmacology & Therapeutics (1997) 62, 171–180; doi:</description><subject>Adult</subject><subject>Antigens, CD - metabolism</subject><subject>Biological and medical sciences</subject><subject>Bones, joints and connective tissue. Antiinflammatory agents</subject><subject>Double-Blind Method</subject><subject>Escherichia coli</subject><subject>Female</subject><subject>Half-Life</subject><subject>Humans</subject><subject>Injections, Subcutaneous</subject><subject>Interleukin 1 Receptor Antagonist Protein</subject><subject>Interleukin-1 - metabolism</subject><subject>Interleukin-10 - adverse effects</subject><subject>Interleukin-10 - pharmacokinetics</subject><subject>Interleukin-10 - pharmacology</subject><subject>Lipopolysaccharides - pharmacology</subject><subject>Lymphocyte Activation - drug effects</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Pharmacology. Drug treatments</subject><subject>Receptors, Interleukin-1 - metabolism</subject><subject>Receptors, Tumor Necrosis Factor - metabolism</subject><subject>Receptors, Tumor Necrosis Factor, Type I</subject><subject>Recombinant Proteins - adverse effects</subject><subject>Recombinant Proteins - pharmacokinetics</subject><subject>Recombinant Proteins - pharmacology</subject><subject>Safety</subject><subject>Sialoglycoproteins - metabolism</subject><subject>T-Lymphocytes - drug effects</subject><subject>T-Lymphocytes - metabolism</subject><subject>Tumor Necrosis Factor-alpha - metabolism</subject><issn>0009-9236</issn><issn>1532-6535</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1997</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqNkF9r2zAUxUXZaNNuH6HgwSjbg1v9t_RYQtcNAg00Y4_iWlaIW1nOJKsl335OneZ5T5fL-d1zDwehS4KvCSby5hFjrEtNmfymq-8aYylKcYJmRDBaSsHEBzQ7ImfoPKWnceVaqVN0qqniSrAZ-rPcQOzA9s0uQNfaVPTrIuXa5gGC63MqorN9V7cBwlBscgehaMPgonf5uQ0lweNabBz4YbMrXnqfR9HF9Al9XINP7vNhXqDfP-5W85_l4uH-1_x2UVoutSihYUozDhVzEltWKywVayqhamVB0jGtlZJaTQl1xBGCG1lzZgnjDYdGK3aBribfbez_ZpcG07XJOu-n9KbSVEhO9QiKCbSxTym6tdnGtoO4MwSbfaHmrVCzb8voyrwVasR4d3l4kOvONcerQ4Oj_vWgQ7Lg1xGCbdMRo4owqfiI3U7Ya-vd7v9-m_lyNV8sV0TriuB9lC-TR4AhR3c0sX47vDP_ADOnnIM</recordid><startdate>199708</startdate><enddate>199708</enddate><creator>Huhn, Richard D.</creator><creator>Radwanski, Elaine</creator><creator>Gallo, Jose</creator><creator>Affrime, Melton B.</creator><creator>Sabo, Ron</creator><creator>Gonyo, Gerilyn</creator><creator>Monge, April</creator><creator>Cutler, David L.</creator><general>Nature Publishing</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>199708</creationdate><title>Pharmacodynamics of subcutaneous recombinant human interleukin-10 in healthy volunteers</title><author>Huhn, Richard D. ; Radwanski, Elaine ; Gallo, Jose ; Affrime, Melton B. ; Sabo, Ron ; Gonyo, Gerilyn ; Monge, April ; Cutler, David L.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4695-ad38934a73e60c3b80683d758b8ca62498c662c9212e1e110d6b43c134d4ad983</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1997</creationdate><topic>Adult</topic><topic>Antigens, CD - metabolism</topic><topic>Biological and medical sciences</topic><topic>Bones, joints and connective tissue. Antiinflammatory agents</topic><topic>Double-Blind Method</topic><topic>Escherichia coli</topic><topic>Female</topic><topic>Half-Life</topic><topic>Humans</topic><topic>Injections, Subcutaneous</topic><topic>Interleukin 1 Receptor Antagonist Protein</topic><topic>Interleukin-1 - metabolism</topic><topic>Interleukin-10 - adverse effects</topic><topic>Interleukin-10 - pharmacokinetics</topic><topic>Interleukin-10 - pharmacology</topic><topic>Lipopolysaccharides - pharmacology</topic><topic>Lymphocyte Activation - drug effects</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Pharmacology. Drug treatments</topic><topic>Receptors, Interleukin-1 - metabolism</topic><topic>Receptors, Tumor Necrosis Factor - metabolism</topic><topic>Receptors, Tumor Necrosis Factor, Type I</topic><topic>Recombinant Proteins - adverse effects</topic><topic>Recombinant Proteins - pharmacokinetics</topic><topic>Recombinant Proteins - pharmacology</topic><topic>Safety</topic><topic>Sialoglycoproteins - metabolism</topic><topic>T-Lymphocytes - drug effects</topic><topic>T-Lymphocytes - metabolism</topic><topic>Tumor Necrosis Factor-alpha - metabolism</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Huhn, Richard D.</creatorcontrib><creatorcontrib>Radwanski, Elaine</creatorcontrib><creatorcontrib>Gallo, Jose</creatorcontrib><creatorcontrib>Affrime, Melton B.</creatorcontrib><creatorcontrib>Sabo, Ron</creatorcontrib><creatorcontrib>Gonyo, Gerilyn</creatorcontrib><creatorcontrib>Monge, April</creatorcontrib><creatorcontrib>Cutler, David L.</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical pharmacology and therapeutics</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Huhn, Richard D.</au><au>Radwanski, Elaine</au><au>Gallo, Jose</au><au>Affrime, Melton B.</au><au>Sabo, Ron</au><au>Gonyo, Gerilyn</au><au>Monge, April</au><au>Cutler, David L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Pharmacodynamics of subcutaneous recombinant human interleukin-10 in healthy volunteers</atitle><jtitle>Clinical pharmacology and therapeutics</jtitle><addtitle>Clin Pharmacol Ther</addtitle><date>1997-08</date><risdate>1997</risdate><volume>62</volume><issue>2</issue><spage>171</spage><epage>180</epage><pages>171-180</pages><issn>0009-9236</issn><eissn>1532-6535</eissn><coden>CLPTAT</coden><abstract>Interleukin‐10 inhibits T‐lymphocyte activation and proliferation and lipopolysaccharide‐induced monocyte production of proinflammatory cytokines. Fifty‐four healthy volunteers received single doses of recombinant human interleukin‐10 (1.0, 2.5, 5.0, 10, 25, or 50 μg/kg) or placebo by subcutaneous injection (randomized double‐blind assignment). Clinical adverse events were infrequent at doses below 50 μg/kg (five of six subjects had mild flu‐like syndrome). Mean serum interleukin‐10 concentrations were dose related. The mean terminal‐phase half‐life ranged from 2.7 to 4.5 hours, and the apparent volume of distribution ranged from 0.70 to 1.35 L/kg. Hematologic changes included transient mild to moderate increases of neutrophil counts, decreases of lymphocyte counts, and a delayed decrease of platelet counts. Recombinant human interleukin‐10 significantly suppressed production of the proinflammatory cytokines interleukin‐1β and tumor necrosis factor‐α by whole blood stimulated ex vivo with Escherichia coli lipopolysaccharide.
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| subjects | Adult Antigens, CD - metabolism Biological and medical sciences Bones, joints and connective tissue. Antiinflammatory agents Double-Blind Method Escherichia coli Female Half-Life Humans Injections, Subcutaneous Interleukin 1 Receptor Antagonist Protein Interleukin-1 - metabolism Interleukin-10 - adverse effects Interleukin-10 - pharmacokinetics Interleukin-10 - pharmacology Lipopolysaccharides - pharmacology Lymphocyte Activation - drug effects Male Medical sciences Pharmacology. Drug treatments Receptors, Interleukin-1 - metabolism Receptors, Tumor Necrosis Factor - metabolism Receptors, Tumor Necrosis Factor, Type I Recombinant Proteins - adverse effects Recombinant Proteins - pharmacokinetics Recombinant Proteins - pharmacology Safety Sialoglycoproteins - metabolism T-Lymphocytes - drug effects T-Lymphocytes - metabolism Tumor Necrosis Factor-alpha - metabolism |
| title | Pharmacodynamics of subcutaneous recombinant human interleukin-10 in healthy volunteers |
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