ID
38182
Descrição
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 participant's demographic data (as well as the items taken from the Inform Screening and Inform Enrolment forms) and is to be filled in at Screening. Cohorts and Randomisation information from the Screening Visit is recorded in the IV Dosing Form.
Link
https://clinicaltrials.gov/ct2/show/NCT01476046
Palavras-chave
Versões (1)
- 24/09/2019 24/09/2019 -
Titular dos direitos
GlaxoSmithKline
Transferido a
24 de setembro de 2019
DOI
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Licença
Creative Commons BY-NC 3.0
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Phase I Trial of Intravenous TNFR1 Antagonist GSK1995057 in Healthy Subjects - NCT01476046
Demography
- StudyEvent: ODM
Descrição
Demography
Alias
- UMLS CUI-1
- C0011298
Descrição
Enter subject’s date of birth, if you are unable to provide a full date of birth, enter a partial date of birth. It be imputed if a partial date is entered based on the following conditions: If partial date of birth of UNK/MMM/YYYY = 15/MMM/YYYY If partial date of birth of UNK/UNK/YYYY = 30/JUN/YYYY
Tipo de dados
partialDate
Alias
- UMLS CUI [1]
- C0421451
Descrição
hidden and set to "---"
Tipo de dados
text
Alias
- UMLS CUI [1]
- C2986440
Descrição
Female: Record child-bearing potential
Tipo de dados
text
Alias
- UMLS CUI [1]
- C0079399
Descrição
if applicable
Tipo de dados
integer
Alias
- UMLS CUI [1]
- C3831118
Descrição
Ethnicity
Tipo de dados
integer
Alias
- UMLS CUI [1]
- C0015031
Descrição
Geographic ancestry
Alias
- UMLS CUI-1
- C3841890
Descrição
African American/African Heritage
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0085756
- UMLS CUI [2]
- C0027567
Descrição
American Indian or Alaskan Native
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C1515945
Descrição
Central/South Asian Heritage
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0238696
- UMLS CUI [2]
- C1519427
Descrição
East Asian Heritage
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C4540996
Descrição
Japanese Heritage
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C1556094
Descrição
South East Asian Heritage
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0238697
Descrição
Native Hawaiian or Other Pacific Islander
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C1513907
Descrição
White - Arabic/North African Heritage
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0238604
- UMLS CUI [2]
- C2698217
Descrição
White/Caucasian/European Heritage
Tipo de dados
boolean
Alias
- UMLS CUI [1]
- C0043157
Similar models
Demography
- StudyEvent: ODM
C1264639 (UMLS CUI [1,2])
C0027567 (UMLS CUI [2])
C1519427 (UMLS CUI [2])
C2698217 (UMLS CUI [2])