ID
38913
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 protocol deviations, and is filled in by the Sponsor's (GSK) monitoring staff only.
Link
https://clinicaltrials.gov/ct2/show/NCT01476046
Keywords
Versions (2)
- 10/25/19 10/25/19 -
- 11/12/19 11/12/19 - Sarah Riepenhausen
Copyright Holder
GlaxoSmithKline
Uploaded on
November 12, 2019
DOI
To request one please log in.
License
Creative Commons BY-NC 3.0
Model comments :
You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.
Itemgroup comments for :
Item comments for :
In order to download data models you must be logged in. Please log in or register for free.
Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046
Protocol Deviation
- StudyEvent: ODM
Description
Protocol Deviations
Alias
- UMLS CUI-1
- C1705236
Description
Protocol Deviation Number
Data type
integer
Alias
- UMLS CUI [1,1]
- C1705236
- UMLS CUI [1,2]
- C0600091
Description
[hidden]
Data type
integer
Alias
- UMLS CUI [1]
- C2826182
Description
[hidden] Specify Other protocol deviation below; select sub-category for Visit window, Administer/Dispense Study Medication, Study Treatment Supply Procedures, Biological Specimen Sample Procedures, Equipment Procedures, Randomization Procedures
Data type
text
Alias
- UMLS CUI [1]
- C1705236
Description
Specify other protocol deviation
Data type
text
Alias
- UMLS CUI [1,1]
- C0205394
- UMLS CUI [1,2]
- C1705236
- UMLS CUI [1,3]
- C1521902
Description
Protocol deviation: Visit
Data type
text
Alias
- UMLS CUI [1,1]
- C1705236
- UMLS CUI [1,2]
- C0545082
Description
Specify other Protocol Deviation: Visit
Data type
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1705236
- UMLS CUI [1,4]
- C0545082
Description
Protocol Deviation: Administration/Dispensing Study Medication
Data type
text
Alias
- UMLS CUI [1,1]
- C1705236
- UMLS CUI [1,2]
- C1880359
- UMLS CUI [1,3]
- C0304229
- UMLS CUI [2,1]
- C1705236
- UMLS CUI [2,2]
- C1533734
- UMLS CUI [2,3]
- C0304229
Description
Specify other Protocol Deviation: Administration/Dispensing Study Medication
Data type
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1705236
- UMLS CUI [1,4]
- C1880359
- UMLS CUI [1,5]
- C0304229
- UMLS CUI [2,1]
- C1521902
- UMLS CUI [2,2]
- C0205394
- UMLS CUI [2,3]
- C1705236
- UMLS CUI [2,4]
- C1533734
- UMLS CUI [2,5]
- C0304229
Description
Protocol Deviation: Study Treatment Supply
Data type
text
Alias
- UMLS CUI [1,1]
- C1705236
- UMLS CUI [1,2]
- C0243163
- UMLS CUI [1,3]
- C0304229
Description
Specify other Protocol Deviation: Study Treatment Supply
Data type
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1705236
- UMLS CUI [1,4]
- C0243163
- UMLS CUI [1,5]
- C0304229
Description
Protocol Deviation: Biological Specimens
Data type
text
Alias
- UMLS CUI [1,1]
- C1705236
- UMLS CUI [1,2]
- C2347026
Description
Specify other Protocol Deviation: Biological Specimens
Data type
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1705236
- UMLS CUI [1,4]
- C2347026
Description
Protocol Deviation: Equipment
Data type
text
Alias
- UMLS CUI [1,1]
- C1705236
- UMLS CUI [1,2]
- C0014672
Description
Specify other Protocol Deviation: Equipment
Data type
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1705236
- UMLS CUI [1,4]
- C0014672
Description
Protocol Deviation: Randomization
Data type
text
Alias
- UMLS CUI [1,1]
- C1705236
- UMLS CUI [1,2]
- C0034656
Description
Specify other Protocol Deviation: Randomization
Data type
text
Alias
- UMLS CUI [1,1]
- C1521902
- UMLS CUI [1,2]
- C0205394
- UMLS CUI [1,3]
- C1705236
- UMLS CUI [1,4]
- C0034656
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C1705236
- UMLS CUI [1,2]
- C0678257
Description
[hidden]
Data type
partialDate
Alias
- UMLS CUI [1,1]
- C0011008
- UMLS CUI [1,2]
- C1880355
- UMLS CUI [1,3]
- C1705236
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C1705236
- UMLS CUI [1,2]
- C1547656
Description
[hidden]
Data type
text
Alias
- UMLS CUI [1,1]
- C1705236
- UMLS CUI [1,2]
- C0031831
- UMLS CUI [1,3]
- C2347796
- UMLS CUI [1,4]
- C1283169
Similar models
Protocol Deviation
- StudyEvent: ODM
C0600091 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,2])
C1521902 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
C0545082 (UMLS CUI [1,4])
C1880359 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C1705236 (UMLS CUI [2,1])
C1533734 (UMLS CUI [2,2])
C0304229 (UMLS CUI [2,3])
C0205394 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
C1880359 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C1521902 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C1705236 (UMLS CUI [2,3])
C1533734 (UMLS CUI [2,4])
C0304229 (UMLS CUI [2,5])
C0243163 (UMLS CUI [1,2])
C0304229 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
C0243163 (UMLS CUI [1,4])
C0304229 (UMLS CUI [1,5])
C2347026 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
C2347026 (UMLS CUI [1,4])
C0014672 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
C0014672 (UMLS CUI [1,4])
C0034656 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
C0034656 (UMLS CUI [1,4])
C0678257 (UMLS CUI [1,2])
C1880355 (UMLS CUI [1,2])
C1705236 (UMLS CUI [1,3])
C1547656 (UMLS CUI [1,2])
C0031831 (UMLS CUI [1,2])
C2347796 (UMLS CUI [1,3])
C1283169 (UMLS CUI [1,4])