ID
38498
Beschrijving
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 is to be filled in at the end of the study (regular follow-up or study discontinuation) and lists whether any repeated/additional investigations were performed and/or whether certain events occured in the participant, such as (Non-)Serious Adverse Events. Details about the investigations/events are recorded in different forms.
Link
https://clinicaltrials.gov/ct2/show/NCT01476046
Trefwoorden
Versies (2)
- 22-10-19 22-10-19 -
- 20-09-21 20-09-21 -
Houder van rechten
GlaxoSmithKline
Geüploaded op
22 oktober 2019
DOI
Voor een aanvraag inloggen.
Licentie
Creative Commons BY-NC 3.0
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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046
Logs and Repeats
- StudyEvent: ODM
Beschrijving
Adverse Event/Concomitant Medication/Unscheduled Assessment Check Questions
Alias
- UMLS CUI-1
- C0877248
- UMLS CUI-2
- C2347852
- UMLS CUI-3
- C3854240
- UMLS CUI-4
- C0220825
Beschrijving
Concomitant medication
Datatype
text
Alias
- UMLS CUI [1]
- C2347852
Beschrijving
Non-serious adverse events
Datatype
text
Alias
- UMLS CUI [1]
- C1518404
Beschrijving
Serious adverse events
Datatype
text
Alias
- UMLS CUI [1]
- C1519255
Beschrijving
Unscheduled ECGs
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C3854240
Beschrijving
Abnormal, clinically significant ECG
Datatype
text
Alias
- UMLS CUI [1,1]
- C1832603
- UMLS CUI [1,2]
- C2985739
Beschrijving
Unscheduled vital signs
Datatype
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C3854240
Beschrijving
Unscheduled spirometry
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0037981
Beschrijving
Unscheduled pharmacokinetic samples
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0005834
Beschrijving
Unscheduled Holter
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C3854240
Beschrijving
Abnormal, clinically significant Holter or Telemetry
Datatype
text
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C0522055
- UMLS CUI [1,3]
- C2826293
- UMLS CUI [2,1]
- C0039451
- UMLS CUI [2,2]
- C2826293
- UMLS CUI [2,3]
- C0205161
Beschrijving
Unscheduled Immunogenicity
Datatype
text
Alias
- UMLS CUI [1,1]
- C4054739
- UMLS CUI [1,2]
- C3854240
Beschrijving
Unscheduled Biomarker Serum
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0005516
- UMLS CUI [1,3]
- C0229671
Beschrijving
Unscheduled Biomarker Assessment from Whole Blood
Datatype
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0005516
- UMLS CUI [1,3]
- C0370231
Beschrijving
[hidden]
Datatype
text
Alias
- UMLS CUI [1]
- C1705236
Beschrijving
Liver Event
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Beschrijving
If yes, please complete the Liver Event form(s).
Datatype
text
Alias
- UMLS CUI [1,1]
- C0023901
- UMLS CUI [1,2]
- C0008000
- UMLS CUI [1,3]
- C0587081
- UMLS CUI [1,4]
- C0243161
- UMLS CUI [1,5]
- C2746065
- UMLS CUI [1,6]
- C0304229
Similar models
Logs and Repeats
- StudyEvent: ODM
C0545082 (UMLS CUI [1,2])
C1264639 (UMLS CUI [2,1])
C1516048 (UMLS CUI [2,2])
C2347852 (UMLS CUI-2)
C3854240 (UMLS CUI-3)
C0220825 (UMLS CUI-4)
C3854240 (UMLS CUI [1,2])
C2985739 (UMLS CUI [1,2])
C3854240 (UMLS CUI [1,2])
C0037981 (UMLS CUI [1,2])
C0031328 (UMLS CUI [1,2])
C0005834 (UMLS CUI [1,3])
C3854240 (UMLS CUI [1,2])
C0522055 (UMLS CUI [1,2])
C2826293 (UMLS CUI [1,3])
C0039451 (UMLS CUI [2,1])
C2826293 (UMLS CUI [2,2])
C0205161 (UMLS CUI [2,3])
C3854240 (UMLS CUI [1,2])
C0005516 (UMLS CUI [1,2])
C0229671 (UMLS CUI [1,3])
C0005516 (UMLS CUI [1,2])
C0370231 (UMLS CUI [1,3])
C0008000 (UMLS CUI [1,2])
C0587081 (UMLS CUI [1,3])
C0243161 (UMLS CUI [1,4])
C2746065 (UMLS CUI [1,5])
C0304229 (UMLS CUI [1,6])