{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T02:32:21Z","timestamp":1789439541406,"version":"build-2803163510"},"reference-count":10,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2014,7,8]],"date-time":"2014-07-08T00:00:00Z","timestamp":1404777600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["The Journal of Clinical Pharma"],"published-print":{"date-parts":[[2014,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:label\/><jats:p>Here we report the results of a first\u2010in\u2010human study to evaluate the safety, tolerability pharmacokinetics, and pharmacodynamics of abediterol, a new \u03b2<jats:sub>2<\/jats:sub>\u2010adrenergic agonist. Forty\u2010eight healthy males aged 18\u201345 years received abediterol doses of 5, 10, 25, or 50\u2009\u00b5g, or placebo. Safety and tolerability assessments included adverse event reporting, pulse and blood pressure monitoring, 12\u2010lead electrocardiograms, laboratory tests, and physical examination. Pharmacodynamic assessments included whole body plethysmography to determine the bronchodilatory effect by means of airway conductance and resistance. Blood and urine samples were obtained for pharmacokinetic analyses. Abediterol showed an overall good safety and tolerability profile in the dose range tested, consistent with the expected characteristics of a \u03b2<jats:sub>2<\/jats:sub>\u2010adrenergic agonist. A dose\u2010dependent increase of systemic treatment\u2010emergent adverse events was observed, the most frequent being palpitations, tremor, nausea, and asthenia; most were mild in intensity and resolved without the need for intervention. Improvements in airway conductance (increase) and resistance (decrease) were greater for all doses of abediterol tested compared with placebo at all time\u2010points up to 36\u2009hours. This first\u2010in\u2010human study suggests a potent, rapid, and sustained bronchodilatory effect of abediterol in healthy male subjects. Lower doses are currently under investigation in patients with asthma and in patients with COPD.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jcph.355","type":"journal-article","created":{"date-parts":[[2014,7,2]],"date-time":"2014-07-02T17:55:25Z","timestamp":1404323725000},"page":"1347-1353","source":"Crossref","is-referenced-by-count":19,"title":["First\u2010in\u2010human study of the safety, tolerability, pharmacokinetics and pharmacodynamics of abediterol (LAS100977), a novel long\u2010acting \u0392<sub>2<\/sub>\u2010agonist"],"prefix":"10.1002","volume":"54","author":[{"given":"Wolfgang","family":"Timmer","sequence":"first","affiliation":[{"name":"Clinical Research Services Mannheim GmbH Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eric","family":"Massana","sequence":"additional","affiliation":[{"name":"R&amp;D Centre Almirall Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eulalia","family":"Jimenez","sequence":"additional","affiliation":[{"name":"R&amp;D Centre Almirall Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Beatriz","family":"Seoane","sequence":"additional","affiliation":[{"name":"R&amp;D Centre Almirall Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gonzalo","family":"de Miquel","sequence":"additional","affiliation":[{"name":"R&amp;D Centre Almirall Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sandrine","family":"Ruiz","sequence":"additional","affiliation":[{"name":"R&amp;D Centre Almirall Barcelona Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2014,7,8]]},"reference":[{"key":"e_1_2_7_2_1","unstructured":"Global Initiative for Asthma. Global Initiative for Asthma. 2012.www.ginasthma.org. Accessed October 17 2012."},{"key":"e_1_2_7_3_1","unstructured":"Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis management and prevention of chronic obstructive pulmonary disease. 2013.http:\/\/www.goldcopd.org\/uploads\/users\/files\/GOLD_Report_2013_Feb20.pdf. Accessed October 3 2013."},{"key":"e_1_2_7_4_1","unstructured":"World Health Organisation. World Health Report 2000. 2000.http:\/\/www.who.int\/whr\/2000\/en\/."},{"key":"e_1_2_7_5_1","unstructured":"British Thoracic Society Scottish Intercollegiate Guidelines Network. British guideline on the management of asthma: a national clinical guideline. 2012.http:\/\/www.brit\u2010thoracic.org.uk\/guidelines\/asthma\u2010guidelines.aspxAccessed September 2013."},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.112.193284"},{"key":"e_1_2_7_7_1","unstructured":"FDA Gudiance for Industry on \u201cEstimating the Maximum Safe Starting dose in Initial Clinical Trials for Therapeutics in Adults Healthy Volunteers.\u201d July 2005."},{"key":"e_1_2_7_8_1","doi-asserted-by":"crossref","unstructured":"BeierJ FuhrR Massana\u00c8 et al. Efficacy and safety of single inhaled doses of LAS100977 a novel long acting \u03b22\u2010agonist in patients with persistent asthma. Poster presented at: American Thoracic Society International Conference New Orleans Louisiana USA May 14\u201319 2010.","DOI":"10.1164\/ajrccm-conference.2010.181.1_MeetingAbstracts.A5414"},{"key":"e_1_2_7_9_1","unstructured":"SinghD PujolH RiberaA et al. Efficacy and safety of abediterol (LAS100977) in stable asthma: Phase II randomized crossover study. Poster presented at: European Respiratory Society Annual Congress Barcelona Spain September 7\u201311 2013 2013."},{"key":"e_1_2_7_10_1","first-page":"506","volume":"46","author":"AACR Clinical Practice Guidelines","year":"2001","journal-title":"Respir Care"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pupt.2010.10.006"}],"container-title":["The Journal of Clinical Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1002%2Fjcph.355","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/jcph.355","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,6]],"date-time":"2023-10-06T00:42:18Z","timestamp":1696552938000},"score":1,"resource":{"primary":{"URL":"https:\/\/accp1.onlinelibrary.wiley.com\/doi\/10.1002\/jcph.355"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,7,8]]},"references-count":10,"journal-issue":{"issue":"12","published-print":{"date-parts":[[2014,12]]}},"alternative-id":["10.1002\/jcph.355"],"URL":"https:\/\/doi.org\/10.1002\/jcph.355","archive":["Portico"],"relation":{},"ISSN":["0091-2700","1552-4604"],"issn-type":[{"value":"0091-2700","type":"print"},{"value":"1552-4604","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,7,8]]}}}