ID

38908

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 (repeatedly, if necessary) during the study and/or at the end of the study in case of non-serious adverse events.

Link

https://clinicaltrials.gov/ct2/show/NCT01476046

Keywords

Versions (3)
  1. 10/22/19 10/22/19 -
  2. 10/22/19 10/22/19 -
  3. 11/12/19 11/12/19 - Sarah Riepenhausen
Copyright Holder

GlaxoSmithKline

Uploaded on

November 12, 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

English

Non-serious AE

1 forms  
  1. StudyEvent: ODM
    1. Non-serious AE
Administrative data
Description

Administrative data

Alias
UMLS CUI-1
C1320722
Date/Time of Assessment
Description

Date/Time of Assessment

Data type

datetime

Alias
UMLS CUI [1,1]
C2985720
UMLS CUI [1,2]
C1264639
Subject Number
Description

Subject Number

Data type

integer

Alias
UMLS CUI [1]
C2348585
Non-serious adverse event
Description

Non-serious adverse event

Alias
UMLS CUI-1
C1518404
Sequence Number
Description

Hidden

Data type

text

Alias
UMLS CUI [1,1]
C2348184
UMLS CUI [1,2]
C1518404
Event Diagnosis Only (if known) Otherwise Sign/Symptom
Description

Diagnosis or Sign/Symptom

Data type

text

Alias
UMLS CUI [1]
C0011900
UMLS CUI [2]
C3540840
Adverse Event Modified Reported Term
Description

Hidden

Data type

text

Alias
UMLS CUI [1]
C2826798
MedDRA synonym
Description

Hidden

Data type

text

Alias
UMLS CUI [1]
C1140263
MedDRA lower level term code
Description

Hidden

Data type

text

Alias
UMLS CUI [1]
C3898442
Failed coding
Description

Hidden

Data type

boolean

Alias
UMLS CUI [1,1]
C0805701
UMLS CUI [1,2]
C0231175
Start Date and Time
Description

Start Date/Time

Data type

partialDatetime

Alias
UMLS CUI [1]
C2826806
Outcome
Description

if Recovered/Resolved (with or without sequelae) provide End Date and Time

Data type

integer

Alias
UMLS CUI [1]
C1705586
End Date and Time
Description

if applicable

Data type

partialDatetime

Alias
UMLS CUI [1]
C2826793
Non-serious adverse event frequency
Description

Non-serious adverse event frequency

Data type

integer

Alias
UMLS CUI [1,1]
C0439603
UMLS CUI [1,2]
C1518404
Adverse Event Maximum Intensity
Description

[hidden]

Data type

text

Alias
UMLS CUI [1]
C1710066
Adverse Event Maximum Grade
Description

Adverse Event Maximum Grade

Data type

text

Alias
UMLS CUI [1,1]
C0441799
UMLS CUI [1,2]
C1710066
Adverse Event Maximum Grade or Intensity
Description

[hidden]

Data type

text

Alias
UMLS CUI [1,1]
C0441799
UMLS CUI [1,2]
C1710066
UMLS CUI [2,1]
C0518690
UMLS CUI [2,2]
C1518404
Action Taken with Investigational Product(s) as a Result of the AE
Description

Action regarding Investigational Product because of non-serious adverse event

Data type

text

Alias
UMLS CUI [1,1]
C1704758
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1518404
Did the subject withdraw from study as a result of this AE?
Description

subject withdrawal because of non-serious adverse event

Data type

text

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0566251
UMLS CUI [1,3]
C1518404
Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
Description

AE possibly caused by investigational product

Data type

text

Alias
UMLS CUI [1,1]
C0304229
UMLS CUI [1,2]
C0085978
UMLS CUI [1,3]
C1518404
Duration of AE if < 24 hours
Description

[hidden] If AE start and end time are used this item must be hidden.

Data type

time

Alias
UMLS CUI [1,1]
C0449238
UMLS CUI [1,2]
C1518404
Time to Onset Since Last Dose
Description

[hidden]

Data type

time

Alias
UMLS CUI [1,1]
C1272706
UMLS CUI [1,2]
C1517741
UMLS CUI [1,3]
C0178602
UMLS CUI [1,4]
C0439659
UMLS CUI [1,5]
C1518404
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Similar models

Non-serious AE

1 forms
  1. StudyEvent: ODM
    1. Non-serious AE
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative data
C1320722 (UMLS CUI-1)
Date/Time of Assessment
Item
Date/Time of Assessment
datetime
C2985720 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Item Group
Non-serious adverse event
C1518404 (UMLS CUI-1)
Non-serious AE Sequence Number
Item
Sequence Number
text
C2348184 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Diagnosis or Sign/Symptom
Item
Event Diagnosis Only (if known) Otherwise Sign/Symptom
text
C0011900 (UMLS CUI [1])
C3540840 (UMLS CUI [2])
Adverse Event Modified Reported Term
Item
Adverse Event Modified Reported Term
text
C2826798 (UMLS CUI [1])
MedDRA synonym
Item
MedDRA synonym
text
C1140263 (UMLS CUI [1])
MedDRA lower level term code
Item
MedDRA lower level term code
text
C3898442 (UMLS CUI [1])
Failed coding
Item
Failed coding
boolean
C0805701 (UMLS CUI [1,1])
C0231175 (UMLS CUI [1,2])
Start Date/Time
Item
Start Date and Time
partialDatetime
C2826806 (UMLS CUI [1])
Item
Outcome
integer
C1705586 (UMLS CUI [1])
Outcome
Code List
Outcome
CL Item
Recovered/Resolved,  (1)
CL Item
Recovering/Resolving (2)
CL Item
Not recovered/Not resolved (3)
CL Item
Recovered/Resolved with sequelae (4)
End Date/Time
Item
End Date and Time
partialDatetime
C2826793 (UMLS CUI [1])
Item
Non-serious adverse event frequency
integer
C0439603 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Frequency
Code List
Non-serious adverse event frequency
CL Item
Single Episode (1)
CL Item
Intermittent (2)
Item
Adverse Event Maximum Intensity
text
C1710066 (UMLS CUI [1])
Maximum Intensity
Code List
Adverse Event Maximum Intensity
CL Item
Mild (1)
CL Item
Moderate (2)
CL Item
Severe (3)
CL Item
Not applicable (X)
Item
Adverse Event Maximum Grade
text
C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
Maximum Grade
Code List
Adverse Event Maximum Grade
CL Item
Grade 1 (1)
CL Item
Grade 2 (2)
CL Item
Grade 3 (3)
CL Item
Grade 4 (4)
Item
Adverse Event Maximum Grade or Intensity
text
C0441799 (UMLS CUI [1,1])
C1710066 (UMLS CUI [1,2])
C0518690 (UMLS CUI [2,1])
C1518404 (UMLS CUI [2,2])
Maximum Grade
Code List
Adverse Event Maximum Grade or Intensity
CL Item
Mild or Grade 1 (1)
CL Item
Moderate or Grade 2 (2)
CL Item
Severe or Grade 3 (3)
CL Item
Grade 4 (4)
CL Item
Grade 5 (5)
CL Item
Not applicable (X)
Item
Action Taken with Investigational Product(s) as a Result of the AE
text
C1704758 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
Action regarding Investigational Product
Code List
Action Taken with Investigational Product(s) as a Result of the AE
CL Item
Investigational product(s) withdrawn (1)
CL Item
Dose reduced (2)
CL Item
Dose increased (3)
CL Item
Dose not changed (4)
CL Item
Dose interrupted (5)
CL Item
Not applicable (X)
Item
Did the subject withdraw from study as a result of this AE?
text
C0422727 (UMLS CUI [1,1])
C0566251 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
subject withdrawal because of non-serious adverse event
Code List
Did the subject withdraw from study as a result of this AE?
CL Item
Yes (Y)
CL Item
No (N)
Item
Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
text
C0304229 (UMLS CUI [1,1])
C0085978 (UMLS CUI [1,2])
C1518404 (UMLS CUI [1,3])
AE possibly caused by investigational product
Code List
Is there a reasonable possibility that the AE may have been caused by the investigational product(s)?
CL Item
Yes (Y)
CL Item
No (N)
Duration of AE
Item
Duration of AE if < 24 hours
time
C0449238 (UMLS CUI [1,1])
C1518404 (UMLS CUI [1,2])
Interval between Last Dose and AE Onset
Item
Time to Onset Since Last Dose
time
C1272706 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0439659 (UMLS CUI [1,4])
C1518404 (UMLS CUI [1,5])
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