Cited 4 times in
First-in-human study with new recombinant agalsidase beta (ISU303) in healthy subjects
DC Field | Value | Language |
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dc.contributor.author | 박민수 | - |
dc.contributor.author | 김춘옥 | - |
dc.date.accessioned | 2015-01-06T16:55:48Z | - |
dc.date.available | 2015-01-06T16:55:48Z | - |
dc.date.issued | 2014 | - |
dc.identifier.issn | 0091-2700 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/99044 | - |
dc.description.abstract | ISU303 is a new recombinant agalsidase beta (Agal) enzyme replacement therapy under investigation for Fabry disease, caused by a deficiency in α-galactosidase A activity that leads to fatty deposits in tissues. We evaluated the pharmacokinetic (PK) parameters, safety and tolerability of ISU303 in healthy adult volunteers. The study was a dose block-randomized, double-blinded, placebo-controlled, single-dosing, and dose escalation phase 1 clinical trial. A total of 18 healthy subjects were enrolled (0.3 mg/kg, n = 6; 1.0 mg/kg, n = 6; placebo, n = 6). Blood samples for PK analysis were collected according to planned time. The PK parameters in each 0.3 and 1.0 mg/kg Agal group were as follows: Cmax (mU/mL) 43.19 ± 5.9 and 195.86 ± 32.3; AUClast (h·mU/mL) 207.91 ± 25.1 and 939.96 ± 158.3; t1/2 (hours) 1.13 ± 0.3 and 1.46 ± 0.2; Cl (mL/min/kg) 1.79 ± 0.2 and 1.34 ± 0.2, respectively. There were seven adverse events (AE) overall. All AEs were resolved without any complications. None were related to the study drug. There were no immunogenicity or any significant infusion-related reactions. The new Agal product exhibited a dose-dependent PK and was well tolerated with no significant AEs in healthy adult volunteers. | - |
dc.description.statementOfResponsibility | open | - |
dc.format.extent | 675~681 | - |
dc.relation.isPartOf | JOURNAL OF CLINICAL PHARMACOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Healthy Volunteers | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Immunoglobulin G/blood | - |
dc.subject.MESH | Isoenzymes/adverse effects | - |
dc.subject.MESH | Isoenzymes/blood | - |
dc.subject.MESH | Isoenzymes/immunology | - |
dc.subject.MESH | Isoenzymes/pharmacokinetics* | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Recombinant Proteins/adverse effects | - |
dc.subject.MESH | Recombinant Proteins/blood | - |
dc.subject.MESH | Recombinant Proteins/immunology | - |
dc.subject.MESH | Recombinant Proteins/pharmacokinetics | - |
dc.subject.MESH | Young Adult | - |
dc.subject.MESH | alpha-Galactosidase/adverse effects | - |
dc.subject.MESH | alpha-Galactosidase/blood | - |
dc.subject.MESH | alpha-Galactosidase/immunology | - |
dc.subject.MESH | alpha-Galactosidase/pharmacokinetics* | - |
dc.title | First-in-human study with new recombinant agalsidase beta (ISU303) in healthy subjects | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Pediatrics (소아과학) | - |
dc.contributor.googleauthor | Choon OK Kim | - |
dc.contributor.googleauthor | Eun Sil Oh | - |
dc.contributor.googleauthor | Min Soo Park | - |
dc.identifier.doi | 10.1002/jcph.262 | - |
dc.admin.author | false | - |
dc.admin.mapping | false | - |
dc.contributor.localId | A01468 | - |
dc.contributor.localId | A04735 | - |
dc.relation.journalcode | J01338 | - |
dc.identifier.eissn | 1552-4604 | - |
dc.identifier.pmid | 24408305 | - |
dc.identifier.url | http://onlinelibrary.wiley.com/doi/10.1002/jcph.262/abstract | - |
dc.subject.keyword | agalsidase beta | - |
dc.subject.keyword | pharmacokinetics | - |
dc.subject.keyword | safety | - |
dc.contributor.alternativeName | Park, Min Soo | - |
dc.contributor.affiliatedAuthor | Park, Min Soo | - |
dc.rights.accessRights | free | - |
dc.citation.volume | 54 | - |
dc.citation.number | 6 | - |
dc.citation.startPage | 675 | - |
dc.citation.endPage | 681 | - |
dc.identifier.bibliographicCitation | JOURNAL OF CLINICAL PHARMACOLOGY, Vol.54(6) : 675-681, 2014 | - |
dc.identifier.rimsid | 50229 | - |
dc.type.rims | ART | - |
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