QBW276 ( 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3

299. 嚢胞性線維症


臨床試験数 : 1,695 薬物数 : 1,527 - (DrugBank : 268) / 標的遺伝子数 : 111 - 標的パスウェイ数 : 174
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT02566044
(ClinicalTrials.gov)
September 27, 201718/9/2015Safety, Pharmacokinetics and Pharmacodynamics Study of Inhaled QBW276 in Patients With Cystic FibrosisA Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Inhaled QBW276 in Patients With Cystic FibrosisPulmonary Cystic FibrosisOther: Placebo;Drug: QBW276Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll16Phase 1/Phase 2United States;Germany;United Kingdom
2EUCTR2014-004915-35-DE
(EUCTR)
26/07/201714/10/2015Safety and effect of QBW276 in patients with cystic fibrosis A randomized, double blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of inhaled QBW276 in patients with cystic fibrosis - Safety,pharmacokinetics and pharmacodynamics study of inhaledQBW276 in patients with cystic fibrosis 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: QBW276 300mcg
Product Code: QBW276
INN or Proposed INN: Not established
Other descriptive name: QBW276 Succinate
Product Name: QBW276 1500mcg
Product Code: QBW276
INN or Proposed INN: Not established
Other descriptive name: QBW276 Succinate
Novartis Pharma AGNULLNot Recruiting Female: yes
Male: yes
56 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Germany;United Kingdom
3EUCTR2014-004915-35-GB
(EUCTR)
02/12/201516/10/2015Safety and effect of QBW276 in patients with cystic fibrosisA randomized, double blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of inhaled QBW276 in patients with cystic fibrosis - Safety,pharmacokinetics and pharmacodynamics study of inhaledQBW276 in patients with cystic fibrosis 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: QBW276 300mcg
Product Code: QBW276
INN or Proposed INN: Not established
Other descriptive name: QBW276 Succinate
Product Name: QBW276 1500mcg
Product Code: QBW276
INN or Proposed INN: Not established
Other descriptive name: QBW276 Succinate
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
56Phase 1;Phase 2United States;Germany;United Kingdom