ID
38903
Description
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 Spirometry which is performed at Screening, on Days 1, 2 and 28, in case of early withdrawal and as an unscheduled (repeat) assessment.
Lien
https://clinicaltrials.gov/ct2/show/NCT01476046
Mots-clés
Versions (2)
- 22/10/2019 22/10/2019 -
- 12/11/2019 12/11/2019 - Sarah Riepenhausen
Détendeur de droits
GlaxoSmithKline
Téléchargé le
12 novembre 2019
DOI
Pour une demande vous connecter.
Licence
Creative Commons BY-NC 3.0
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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046
Spirometry
- StudyEvent: ODM
Description
Dosing Date and Time
Alias
- UMLS CUI-1
- C0178602
- UMLS CUI-2
- C1264639
Description
Spirometry
Alias
- UMLS CUI-1
- C0037981
Description
Applicable to Day 1 only. All cohorts have to perform the predose measurement, subjects of cohort 7 additionally the 7 hours post start of infusion measurement and all other cohorts the 6 hours post start of infusion measurement.
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0439564
- UMLS CUI [1,2]
- C3469597
- UMLS CUI [1,3]
- C0304229
Description
for Repeat / Unscheduled assessments
Type de données
integer
Alias
- UMLS CUI [1,1]
- C0037981
- UMLS CUI [1,2]
- C0449788
- UMLS CUI [1,3]
- C0242485
Description
Spirometry Date/Time
Type de données
datetime
Alias
- UMLS CUI [1,1]
- C0037981
- UMLS CUI [1,2]
- C1264639
Description
FEV1
Type de données
float
Unités de mesure
- L
Alias
- UMLS CUI [1]
- C0748133
Description
FVC
Type de données
float
Unités de mesure
- L
Alias
- UMLS CUI [1]
- C1287681
Similar models
Spirometry
- StudyEvent: ODM
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C3469597 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0449788 (UMLS CUI [1,2])
C0242485 (UMLS CUI [1,3])
C1264639 (UMLS CUI [1,2])