ID

38494

Beschreibung

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 the Study Conclusion, information on whether a pregnancy has occured during the study, and the investigator's electronic signature. This form is to be completed at the End of Study after the Follow-up period (Day 85) or if the participant has/was withdrawn from the trial.

Link

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

Stichworte

Versionen (1)
  1. 22.10.19 22.10.19 -
Rechteinhaber

GlaxoSmithKline

Hochgeladen am

22. Oktober 2019

DOI

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Lizenz

Creative Commons BY-NC 3.0
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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046

Englisch

Study Conclusion, Pregnancy, Electronic Signature

1 Formulare  
Administrative Data
Beschreibung

Administrative Data

Alias
UMLS CUI-1
C1320722
Subject Number
Beschreibung

Subject Number

Datentyp

integer

Alias
UMLS CUI [1]
C2348585
Date/Time of Assessment
Beschreibung

Date/Time of Assessment

Datentyp

datetime

Alias
UMLS CUI [1,1]
C1516048
UMLS CUI [1,2]
C1264639
Study Conclusion
Beschreibung

Study Conclusion

Alias
UMLS CUI-1
C1707478
UMLS CUI-2
C0008976
Date of last contact
Beschreibung

Date of last contact must match the last actual contact with the subject whether or not the contact was a clinic visit. Do not record dates of unsuccessful attempts to contact the subject (if subject was withdrawn). Note: An ’actual contact’ is defined as an interaction between the subject and the investigator or investigator’s designee, where the investigator/designee has the opportunity to query the subject about the subject’s status. This would include clinic visits and telephone contacts, but normally would not include mail correspondence or third party reports.

Datentyp

date

Alias
UMLS CUI [1]
C0805839
Was the subject withdrawn from the study?
Beschreibung

Subject withdrawn?

Datentyp

text

Alias
UMLS CUI [1]
C0422727
Date of decision to withdraw
Beschreibung

if applicable Date of decision to withdraw must match the date of subject withdrawal.

Datentyp

date

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C0679006
UMLS CUI [1,3]
C0011008
Primary reason for withdrawal
Beschreibung

if 1 = Adverse Event, please record details on the Non-Serious Adverse Events or Serious Adverse Events forms as appropriate. if 7 = Investigator discretion, specify in next question. Select this reason if none of the other primary reasons are appropriate.

Datentyp

integer

Alias
UMLS CUI [1,1]
C0422727
UMLS CUI [1,2]
C1549995
Investigator discretion, specify
Beschreibung

if applicable

Datentyp

text

Alias
UMLS CUI [1,1]
C2348235
UMLS CUI [1,2]
C0008961
UMLS CUI [1,3]
C0022423
Case book ready for signature [hidden]
Beschreibung

Data owner should check the box when data cleaning is complete

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1706256
UMLS CUI [1,2]
C1519316
Office Use 1 [hidden]
Beschreibung

Office Use 1 [hidden]

Datentyp

text

Alias
UMLS CUI [1]
C0442603
Office Use 2 [hidden]
Beschreibung

Office Use 2 [hidden]

Datentyp

integer

Alias
UMLS CUI [1]
C0442603
Pregnancy Information (female)
Beschreibung

Pregnancy Information (female)

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did the subject become pregnant during the study?
Beschreibung

Subject became pregnant during study

Datentyp

text

Alias
UMLS CUI [1]
C3828490
Pregnancy Information (male)
Beschreibung

Pregnancy Information (male)

Alias
UMLS CUI-1
C0032961
UMLS CUI-2
C1533716
Did a female partner of the male subject become pregnant during the study?
Beschreibung

Check "Not Applicable" if female partner not of childbearing potential or no female partner.

Datentyp

text

Alias
UMLS CUI [1,1]
C0919624
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0008976
CRB Electronic Signature Affidavit
Beschreibung

CRB Electronic Signature Affidavit

Alias
UMLS CUI-1
C2346576
First Name
Beschreibung

By my dated signature below, I, [First Name] [Last Name], verify that all case report form pages accurately display the results of the examinations, tests, evaluations and treatments performed on this patient.

Datentyp

text

Alias
UMLS CUI [1,1]
C2826892
UMLS CUI [1,2]
C1443235
Last Name
Beschreibung

By my dated signature below, I, [First Name] [Last Name], verify that all case report form pages accurately display the results of the examinations, tests, evaluations and treatments performed on this patient.

Datentyp

text

Alias
UMLS CUI [1,1]
C2826892
UMLS CUI [1,2]
C1301584
Date of electronic signature
Beschreibung

Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be the legally binding equivalent of my handwritten signature. To this I do attest by supplying my user name and password and clicking the button marked Submit below.

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
CRF Electronic Signature Affidavit
Beschreibung

CRF Electronic Signature Affidavit

Alias
UMLS CUI-1
C2346576
UMLS CUI-2
C1516308
First Name
Beschreibung

By my dated signature below, I, [First Name] [Last Name], verify that this case report form accurately displays the results of the examinations, tests, evaluations and treatments noted within.

Datentyp

text

Alias
UMLS CUI [1,1]
C2826892
UMLS CUI [1,2]
C1443235
Last Name
Beschreibung

By my dated signature below, I, [First Name] [Last Name], verify that this case report form accurately displays the results of the examinations, tests, evaluations and treatments noted within.

Datentyp

text

Alias
UMLS CUI [1,1]
C2826892
UMLS CUI [1,2]
C1301584
Date of electronic signature
Beschreibung

Pursuant to Section 11.100 of Title 21 of the Code of Federal Regulations, this is to certify that I intend that this electronic signature is to be the legally binding equivalent of my handwritten signature. To this I do attest by supplying my user name and password and clicking the button marked Submit below.

Datentyp

date

Alias
UMLS CUI [1,1]
C2346576
UMLS CUI [1,2]
C0011008
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Ähnliche Modelle

Study Conclusion, Pregnancy, Electronic Signature

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Subject Number
Item
Subject Number
integer
C2348585 (UMLS CUI [1])
Date/Time of Assessment
Item
Date/Time of Assessment
datetime
C1516048 (UMLS CUI [1,1])
C1264639 (UMLS CUI [1,2])
Item Group
Study Conclusion
C1707478 (UMLS CUI-1)
C0008976 (UMLS CUI-2)
Date last contact
Item
Date of last contact
date
C0805839 (UMLS CUI [1])
Item
Was the subject withdrawn from the study?
text
C0422727 (UMLS CUI [1])
Subject withdrawn?
Code List
Was the subject withdrawn from the study?
CL Item
No (N)
CL Item
Yes (Y)
Withdrawal decision date
Item
Date of decision to withdraw
date
C0422727 (UMLS CUI [1,1])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Primary reason for withdrawal
integer
C0422727 (UMLS CUI [1,1])
C1549995 (UMLS CUI [1,2])
primary withdrawal reason
Code List
Primary reason for withdrawal
CL Item
Adverse Event (1)
CL Item
Protocol deviation (3)
CL Item
Study closed/terminated (5)
CL Item
Lost to Follow-up (6)
CL Item
Investigator discretion (7)
CL Item
Withdrew consent (8)
Specification investigator discretion
Item
Investigator discretion, specify
text
C2348235 (UMLS CUI [1,1])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
Case book ready for signature [hidden]
Item
Case book ready for signature [hidden]
boolean
C1706256 (UMLS CUI [1,1])
C1519316 (UMLS CUI [1,2])
Item
Office Use 1 [hidden]
text
C0442603 (UMLS CUI [1])
Subject withdrawn?
Code List
Office Use 1 [hidden]
CL Item
No (N)
CL Item
Yes (Y)
Item
Office Use 2 [hidden]
integer
C0442603 (UMLS CUI [1])
Office Use 2 [hidden]
Code List
Office Use 2 [hidden]
CL Item
1 (1)
CL Item
2 (2)
CL Item
3 (3)
CL Item
4 (4)
CL Item
5 (5)
CL Item
6 (6)
CL Item
7 (7)
CL Item
8 (8)
CL Item
9 (9)
Item Group
Pregnancy Information (female)
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did the subject become pregnant during the study?
text
C3828490 (UMLS CUI [1])
Subject withdrawn?
Code List
Did the subject become pregnant during the study?
CL Item
No (N)
CL Item
Yes (Y)
Item Group
Pregnancy Information (male)
C0032961 (UMLS CUI-1)
C1533716 (UMLS CUI-2)
Item
Did a female partner of the male subject become pregnant during the study?
text
C0919624 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
partner became pregnant during study
Code List
Did a female partner of the male subject become pregnant during the study?
CL Item
No (N)
CL Item
Yes (Y)
CL Item
Not Applicable (X)
Item Group
CRB Electronic Signature Affidavit
C2346576 (UMLS CUI-1)
Investigator First Name
Item
First Name
text
C2826892 (UMLS CUI [1,1])
C1443235 (UMLS CUI [1,2])
Investigator Last Name
Item
Last Name
text
C2826892 (UMLS CUI [1,1])
C1301584 (UMLS CUI [1,2])
Electronic signature date
Item
Date of electronic signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item Group
CRF Electronic Signature Affidavit
C2346576 (UMLS CUI-1)
C1516308 (UMLS CUI-2)
Investigator First Name
Item
First Name
text
C2826892 (UMLS CUI [1,1])
C1443235 (UMLS CUI [1,2])
Investigator Last Name
Item
Last Name
text
C2826892 (UMLS CUI [1,1])
C1301584 (UMLS CUI [1,2])
Electronic signature date
Item
Date of electronic signature
date
C2346576 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
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