{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,19]],"date-time":"2026-05-19T14:20:00Z","timestamp":1779200400529,"version":"3.51.4"},"reference-count":27,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2017,8,8]],"date-time":"2017-08-08T00:00:00Z","timestamp":1502150400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100004191","name":"Novo Nordisk","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100004191","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Endocrinology"],"published-print":{"date-parts":[[2017,10]]},"abstract":"Summary<\/jats:title>Objective<\/jats:title>To evaluate the safety, local tolerability, pharmacodynamics and pharmacokinetics of escalating single doses of once\u2010weekly somapacitan, a reversible, albumin\u2010binding GH<\/jats:styled-content> derivative, vs once\u2010daily GH<\/jats:styled-content> in children with GH<\/jats:styled-content> deficiency (GHD<\/jats:styled-content>).<\/jats:p><\/jats:sec>Design<\/jats:title>Phase 1, randomized, open\u2010label, active\u2010controlled, dose\u2010escalation trial (NCT<\/jats:styled-content>01973244).<\/jats:p><\/jats:sec>Patients<\/jats:title>Thirty\u2010two prepubertal GH<\/jats:styled-content>\u2010treated children with GHD<\/jats:styled-content> were sequentially randomized 3:1 within each of four cohorts to a single dose of somapacitan (0.02, 0.04, 0.08 and 0.16\u00a0mg\/kg; n=6 each), or once\u2010daily Norditropin\u00ae<\/jats:sup> SimpleXx\u00ae<\/jats:sup> (0.03\u00a0mg\/kg; n=2 each) for 7\u00a0days.<\/jats:p><\/jats:sec>Measurements<\/jats:title>Pharmacokinetic and pharmacodynamic profiles were assessed.<\/jats:p><\/jats:sec>Results<\/jats:title>Adverse events were all mild, and there were no apparent treatment\u2010dependent patterns in type or frequency. Four mild transient injection site reactions were reported in three of 24 children treated with somapacitan. No antisomapacitan\/anti\u2010human growth hormone (hGH<\/jats:styled-content>) antibodies were detected. Mean serum concentrations of somapacitan increased in a dose\u2010dependent but nonlinear manner: maximum concentration ranged from 21.8\u00a0ng\/mL<\/jats:styled-content> (0.02\u00a0mg\/kg dose) to 458.4\u00a0ng\/mL<\/jats:styled-content> (0.16\u00a0mg\/kg dose). IGF<\/jats:styled-content>\u2010I and IGFBP<\/jats:styled-content>\u20103, and change from baseline in IGF<\/jats:styled-content>\u2010I standard deviation score (SDS<\/jats:styled-content>) and IGFBP<\/jats:styled-content>\u20103 SDS<\/jats:styled-content>, increased dose dependently; greatest changes in SDS<\/jats:styled-content> values were seen for 0.16\u00a0mg\/kg. IGF<\/jats:styled-content>\u2010I SDS<\/jats:styled-content> values were between \u22122 and +2 SDS<\/jats:styled-content>, except for peak IGF<\/jats:styled-content>\u2010I SDS<\/jats:styled-content> with 0.08\u00a0mg\/kg somapacitan. Postdosing, IGF<\/jats:styled-content>\u2010I SDS<\/jats:styled-content> remained above baseline levels for at least 1\u00a0week.<\/jats:p><\/jats:sec>Conclusions<\/jats:title>Single doses of once\u2010weekly somapacitan (0.02\u20100.16\u00a0mg\/kg) were well tolerated in children with GHD<\/jats:styled-content>, with IGF<\/jats:styled-content>\u2010I profiles supporting a once\u2010weekly treatment profile. No clinically significant safety\/tolerability signals or immunogenicity concerns were identified.<\/jats:p><\/jats:sec>","DOI":"10.1111\/cen.13409","type":"journal-article","created":{"date-parts":[[2017,6,28]],"date-time":"2017-06-28T08:06:39Z","timestamp":1498637199000},"page":"350-358","source":"Crossref","is-referenced-by-count":51,"title":["Somapacitan, a once\u2010weekly reversible albumin\u2010binding GH<\/scp> derivative, in children with GH<\/scp> deficiency: A randomized dose\u2010escalation trial"],"prefix":"10.1111","volume":"87","author":[{"given":"Tadej","family":"Battelino","sequence":"first","affiliation":[{"name":"Faculty of Medicine UMC\u2010University Children's Hospital University of Ljubljana Ljubljana Slovenia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2210-0366","authenticated-orcid":false,"given":"Michael H\u00f8jby","family":"Rasmussen","sequence":"additional","affiliation":[{"name":"Global Development Novo Nordisk A\/S Bagsvaerd Denmark"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jean","family":"De Schepper","sequence":"additional","affiliation":[{"name":"Division of Paediatric Endocrinology UZ Brussel Brussels Belgium"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nehama","family":"Zuckerman\u2010Levin","sequence":"additional","affiliation":[{"name":"Pediatric and Obesity Clinic Rambam Medical Center and Bruce Rappaport Faculty of Medicine Haifa Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Zoran","family":"Gucev","sequence":"additional","affiliation":[{"name":"University Children's Hospital Skopje Macedonia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lars","family":"S\u00e4vendahl","sequence":"additional","affiliation":[{"name":"Department of Women's and Children's Health Karolinska Institutet Pediatric Endocrinology Unit Karolinska University Hospital Stockholm Sweden"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"the NN8640\u20104042 Study Group","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2017,8,8]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1530\/EJE-15-0873"},{"issue":"3","key":"e_1_2_9_3_1","first-page":"327","article-title":"Patient outcomes in the GHMonitor: the effect of delivery device on compliance and growth","volume":"2","author":"Desrosiers P","year":"2005","journal-title":"Pediat Endocrinol Rev"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/adc.2006.114249"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.4158\/EP.14.2.143"},{"key":"e_1_2_9_6_1","unstructured":"MillerBS CrawfordM McNamaraA et\u00a0al. 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