ALN-AAT ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
231α1−アンチトリプシン欠乏症3

231. α1−アンチトリプシン欠乏症


臨床試験数 : 93 薬物数 : 77 - (DrugBank : 8) / 標的遺伝子数 : 10 - 標的パスウェイ数 : 36
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
Inclusion_
agemax
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PhaseCountries
1NCT03767829
(ClinicalTrials.gov)
December 5, 20185/12/2018A Study of ALN-AAT02 in Healthy Participants and Participants With ZZ Type Alpha-1 Antitrypsin Deficiency Liver DiseaseA Phase 1/2, Randomized, Double-blind, Placebo-controlled, Single-ascending and Multiple-dose, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Subcutaneously Administered ALN-AAT02 in Healthy Adult Subjects and Patients With ZZ Type Alpha-1 Antitrypsin Deficiency Liver DiseaseZZ Type Alpha-1 Antitrypsin Deficiency Liver DiseaseDrug: ALN-AAT02;Drug: PlaceboAlnylam PharmaceuticalsNULLTerminated18 Years65 YearsAll32Phase 1/Phase 2United Kingdom
2EUCTR2018-001362-41-GB
(EUCTR)
03/12/201820/06/2019A 2-Part Safety and Tolerability Study of ALN-AAT02 in Healthy Volunteers and Patients with ZZ Type Alpha-1 Antitrypsin Deficiency Liver DiseaseA Phase 1/2, Randomized, Double-blind, Placebo-controlled, Single-ascending and Multiple-dose, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Subcutaneously Administered ALN-AAT02 in Healthy Adult Subjects and Patients with ZZ Type Alpha 1 Antitrypsin Deficiency Liver Disease ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease
MedDRA version: 20.1;Level: PT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ALN-AAT02
Product Code: ALN-AAT02
INN or Proposed INN: ALN-77412
Alnylam Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
96Phase 1;Phase 2United States;Germany;United Kingdom
3EUCTR2015-001297-18-GB
(EUCTR)
29/06/201515/05/2015The First-in-Human Study of an Investigational Drug, ALN-AAT, in Healthy Subjects and Patients with ZZ Type Alpha 1 Antitrypsin Deficiency Liver DiseaseA Phase 1/2, Randomized, Single-Blind, Placebo-Controlled, Single-Ascending, and Multiple-Dose, Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics Study of Subcutaneously Administered ALN-AAT in Healthy Adult Subjects and Patients with ZZ Type Alpha 1 Antitrypsin Deficiency Liver Disease ZZ Type Alpha-1 Antitrypsin Deficiency Liver Disease
MedDRA version: 19.1;Level: PT;Classification code 10001806;Term: Alpha-1 anti-trypsin deficiency;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ALN-AAT
Product Code: ALN-AAT
INN or Proposed INN: ALN-61444
Alnylam Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;United Kingdom