ID
38598
Descripción
Study ID: 110951 Clinical Study ID: 110951 Study Title: A two-part, randomised, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of intravenously infused GSK1995057 in healthy subjects. Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT01476046 See https://clinicaltrials.gov/ct2/show/NCT01476046 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 1 Study Recruitment Status: Completed Generic Name: N/A, Placebo Trade Name: N/A Study Indication: Respiratory Disorders This phase I trial primarily studies the safety and tolerability of ascending single intravenous doses of the selective TNFR1 antagonist GSK1995057 in healthy volunteers, and secondly explores the drug's pharmacodynamics, pharmacokinetics, concentration in lung epithelial lining fluid as well as its effect on immune system markers. The drug is hypothesized to be useful for Acute Lung Injury. The single-centre study consists of two parts A and B with seven cohorts/ten subcohorts in total. Part A includes ascending doses of the investigational product given to subjects negative or positive for pre-existing human anti-heavy chain variable domain (HAVH) antibodies (Cohorts 1 to 3 with Subcohorts 1a, 2a and 3a negative for HAVH and 1b, 2b, 3b positive for HAVH). Part B includes only subjects negative for HAVH, with ascending doses given to Cohorts 4 to 6. Cohort 7 receives the same dose as Cohort 6, but whereas the other Cohorts are single-blinded, Cohort 7 is open-label and additionally receives a bronchoalveolar lavage (BAL). The study consists of a Screening Visit (up to 56 days before Day 1, the day of the drug administration), Visits on Day -1, 1, 2, 3, 5, 7, 14, 28 and Follow-Up Visits on Day 57 and 85. This form contains information on the Bronchoalveolar Lavage (BAL) and the samples collected during it; the BAL is performed for Cohort 7 only on Day 1, 5 hours after infusion start.
Link
https://clinicaltrials.gov/ct2/show/NCT01476046
Palabras clave
Versiones (1)
- 25/10/19 25/10/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
25 de octubre de 2019
DOI
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Licencia
Creative Commons BY-NC 3.0
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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046
Bronchoalveolar Lavage (BAL)
- StudyEvent: ODM
Descripción
Dosing Date and Time
Alias
- UMLS CUI-1
- C0178602
- UMLS CUI-2
- C1264639
Descripción
Bronchoalveolar Lavage
Alias
- UMLS CUI-1
- C1535502
Descripción
i.e. Start of BAL Procedure
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C0200345
- UMLS CUI [1,2]
- C1264639
Descripción
BAL fluid aspirate 1 volume
Tipo de datos
float
Unidades de medida
- mL
Alias
- UMLS CUI [1,1]
- C0006279
- UMLS CUI [1,2]
- C0370199
- UMLS CUI [1,3]
- C0449468
Descripción
BAL fluid aspirate 2 volume
Tipo de datos
float
Unidades de medida
- mL
Alias
- UMLS CUI [1,1]
- C0006279
- UMLS CUI [1,2]
- C0370199
- UMLS CUI [1,3]
- C0449468
Descripción
BAL fluid aspirate 3 volume
Tipo de datos
float
Unidades de medida
- mL
Alias
- UMLS CUI [1,1]
- C0006279
- UMLS CUI [1,2]
- C0370199
- UMLS CUI [1,3]
- C0449468
Descripción
[hidden] Item is not required
Tipo de datos
datetime
Alias
- UMLS CUI [1,1]
- C1535502
- UMLS CUI [1,2]
- C1264639
Similar models
Bronchoalveolar Lavage (BAL)
- StudyEvent: ODM
C1264639 (UMLS CUI [1,2])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])
C0370199 (UMLS CUI [1,2])
C0449468 (UMLS CUI [1,3])
C0370199 (UMLS CUI [1,2])
C0449468 (UMLS CUI [1,3])
C0370199 (UMLS CUI [1,2])
C0449468 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])