ID
38494
Descripción
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 This form is to be completed at the End of Study after the Follow-up period (Day 85) or if the participant has/was withdrawn from the trial.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
Palabras clave
Versiones (1)
- 22/10/19 22/10/19 -
Titular de derechos de autor
GlaxoSmithKline
Subido en
22 de octubre de 2019
DOI
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Licencia
Creative Commons BY-NC 3.0
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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046
Study Conclusion, Pregnancy, Electronic Signature
- StudyEvent: ODM
Descripción
Study Conclusion
Alias
- UMLS CUI-1
- C1707478
- UMLS CUI-2
- C0008976
Descripción
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.
Tipo de datos
date
Alias
- UMLS CUI [1]
- C0805839
Descripción
Subject withdrawn?
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0422727
Descripción
if applicable Date of decision to withdraw must match the date of subject withdrawal.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C0679006
- UMLS CUI [1,3]
- C0011008
Descripción
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.
Tipo de datos
integer
Alias
- UMLS CUI [1,1]
- C0422727
- UMLS CUI [1,2]
- C1549995
Descripción
if applicable
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2348235
- UMLS CUI [1,2]
- C0008961
- UMLS CUI [1,3]
- C0022423
Descripción
Data owner should check the box when data cleaning is complete
Tipo de datos
boolean
Alias
- UMLS CUI [1,1]
- C1706256
- UMLS CUI [1,2]
- C1519316
Descripción
Office Use 1 [hidden]
Tipo de datos
text
Alias
- UMLS CUI [1]
- C0442603
Descripción
Office Use 2 [hidden]
Tipo de datos
integer
Alias
- UMLS CUI [1]
- C0442603
Descripción
Pregnancy Information (female)
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Descripción
Pregnancy Information (male)
Alias
- UMLS CUI-1
- C0032961
- UMLS CUI-2
- C1533716
Descripción
Check "Not Applicable" if female partner not of childbearing potential or no female partner.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C0919624
- UMLS CUI [1,2]
- C0439659
- UMLS CUI [1,3]
- C0347984
- UMLS CUI [1,4]
- C0008976
Descripción
CRB Electronic Signature Affidavit
Alias
- UMLS CUI-1
- C2346576
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2826892
- UMLS CUI [1,2]
- C1443235
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2826892
- UMLS CUI [1,2]
- C1301584
Descripción
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.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Descripción
CRF Electronic Signature Affidavit
Alias
- UMLS CUI-1
- C2346576
- UMLS CUI-2
- C1516308
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2826892
- UMLS CUI [1,2]
- C1443235
Descripción
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.
Tipo de datos
text
Alias
- UMLS CUI [1,1]
- C2826892
- UMLS CUI [1,2]
- C1301584
Descripción
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.
Tipo de datos
date
Alias
- UMLS CUI [1,1]
- C2346576
- UMLS CUI [1,2]
- C0011008
Similar models
Study Conclusion, Pregnancy, Electronic Signature
- StudyEvent: ODM
C1264639 (UMLS CUI [1,2])
C0679006 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
C1549995 (UMLS CUI [1,2])
C0008961 (UMLS CUI [1,2])
C0022423 (UMLS CUI [1,3])
C1519316 (UMLS CUI [1,2])
C1533716 (UMLS CUI-2)
C1533716 (UMLS CUI-2)
C0439659 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0008976 (UMLS CUI [1,4])
C1443235 (UMLS CUI [1,2])
C1301584 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])
C1516308 (UMLS CUI-2)
C1443235 (UMLS CUI [1,2])
C1301584 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,2])