POL6014 ( 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 : 1,696 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_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT03748199
(ClinicalTrials.gov)
November 8, 20185/11/2018Clinical Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of POL6014 in Patients With CFPhase-Ib/IIa Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Inhaled Multiple Doses of POL6014 in Patients With Cystic FibrosisCystic FibrosisDrug: POL6014;Drug: PlaceboSanthera PharmaceuticalsNULLCompleted18 Years55 YearsAll32Phase 1/Phase 2Germany
2EUCTR2018-002550-71-DE
(EUCTR)
12/09/201818/07/2018A clinical study to investigate safety, tolerability and dose of orally inhaled multiple doses of POL6014 in patients with Cystic FibrosisPhase-Ib/IIa study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: POL6014
INN or Proposed INN: lonodelestat
Other descriptive name: CYCLO[L-ALANYL-L-SERYL-L-ISOLEUCYL-L-PROLYL-L-PROLYL-L-GLUTAMINYL-L-LYSYL-L-TYROSYL-D-PROLYL-L-PROLYL-(2S)-2-AMINODECANOYL-L-ALPHA-GLUTAMYL-L-THREONYL]
Santhera Pharmaceuticals (Switzerland) LtdNULLNot RecruitingFemale: yes
Male: yes
32Phase 1;Phase 2Germany
3EUCTR2016-005110-22-DE
(EUCTR)
20/11/201723/06/2017A clinical study to investigate safety, tolerability and dose of orally inhaled multiple doses of POL6014 in patients with Cystic FibrosisPhase-Ib/IIa study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: POL6014Santhera Pharmaceuticals (Switzerland) LtdNULLNot RecruitingFemale: yes
Male: yes
40Phase 1;Phase 2Germany