SPX-101 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
299嚢胞性線維症5

299. 嚢胞性線維症


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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PhaseCountries
1EUCTR2016-005230-30-IT
(EUCTR)
15/11/201705/11/2020A research study to find out if SPX-101 helps people with Cystic Fibrosis and to find out if it is safe.A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects with Cystic Fibrosis (HOPE-1 STUDY: HYDRATION FOR OPTIMAL PULMONARY EFFECTIVENESS) - HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: SPX-101
Product Code: [SPX-101]
INN or Proposed INN: SPX-101
SPYRYX BIOSCIENCES, INC.NULLNot RecruitingFemale: yes
Male: yes
90Phase 2Portugal;France;Canada;Australia;United Kingdom;Italy
2EUCTR2016-005230-30-PT
(EUCTR)
28/08/201731/05/2017A research study to find out if SPX-101 helps people with Cystic Fibrosis and to find out if it is safe.A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects with Cystic Fibrosis (HOPE-1 STUDY: HYDRATION FOR OPTIMAL PULMONARY EFFECTIVENESS) - HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: SPX-101
INN or Proposed INN: SPX-101
Product Name: SPX-101
INN or Proposed INN: SPX-101
Spyryx Biosciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 2France;Portugal;Canada;Australia;Italy;United Kingdom
3NCT03229252
(ClinicalTrials.gov)
August 1, 201714/7/2017An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic FibrosisA Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis (HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness)Cystic FibrosisDrug: Placebo Inhalation Solution;Drug: SPX-101Spyryx Biosciences, Inc.NULLCompleted18 Years50 YearsAll91Phase 2Canada;France;Italy;Portugal;United Kingdom
4EUCTR2016-005230-30-GB
(EUCTR)
14/07/201703/05/2017A research study to find out if SPX-101 helps people with Cystic Fibrosis and to find out if it is safe.A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects with Cystic Fibrosis (HOPE-1 STUDY: HYDRATION FOR OPTIMAL PULMONARY EFFECTIVENESS) - HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: SPX-101
INN or Proposed INN: SPX-101
Product Name: SPX-101
INN or Proposed INN: SPX-101
Spyryx Biosciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 2Portugal;France;Canada;Australia;Italy;United Kingdom
5NCT03056989
(ClinicalTrials.gov)
May 31, 201715/2/2017A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic FibrosisA Phase 1, Single-Center, Open-Label Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic FibrosisCystic FibrosisDrug: SPX-101Spyryx Biosciences, Inc.NULLCompleted18 Years50 YearsAll5Phase 1Canada