ID
38498
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 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
Keywords
Versions (2)
- 10/22/19 10/22/19 -
- 9/20/21 9/20/21 -
Copyright Holder
GlaxoSmithKline
Uploaded on
October 22, 2019
DOI
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License
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
Description
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
Description
Concomitant medication
Data type
text
Alias
- UMLS CUI [1]
- C2347852
Description
Non-serious adverse events
Data type
text
Alias
- UMLS CUI [1]
- C1518404
Description
Serious adverse events
Data type
text
Alias
- UMLS CUI [1]
- C1519255
Description
Unscheduled ECGs
Data type
text
Alias
- UMLS CUI [1,1]
- C0013798
- UMLS CUI [1,2]
- C3854240
Description
Abnormal, clinically significant ECG
Data type
text
Alias
- UMLS CUI [1,1]
- C1832603
- UMLS CUI [1,2]
- C2985739
Description
Unscheduled vital signs
Data type
text
Alias
- UMLS CUI [1,1]
- C0518766
- UMLS CUI [1,2]
- C3854240
Description
Unscheduled spirometry
Data type
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0037981
Description
Unscheduled pharmacokinetic samples
Data type
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0031328
- UMLS CUI [1,3]
- C0005834
Description
Unscheduled Holter
Data type
text
Alias
- UMLS CUI [1,1]
- C0013801
- UMLS CUI [1,2]
- C3854240
Description
Abnormal, clinically significant Holter or Telemetry
Data type
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
Description
Unscheduled Immunogenicity
Data type
text
Alias
- UMLS CUI [1,1]
- C4054739
- UMLS CUI [1,2]
- C3854240
Description
Unscheduled Biomarker Serum
Data type
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0005516
- UMLS CUI [1,3]
- C0229671
Description
Unscheduled Biomarker Assessment from Whole Blood
Data type
text
Alias
- UMLS CUI [1,1]
- C3854240
- UMLS CUI [1,2]
- C0005516
- UMLS CUI [1,3]
- C0370231
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1]
- C1705236
Description
Liver Event
Alias
- UMLS CUI-1
- C0023884
- UMLS CUI-2
- C0877248
Description
If yes, please complete the Liver Event form(s).
Data type
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])