AP-101 ( DrugBank: - )

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1 disease

告示番号	疾患名（ページ内リンク）	臨床試験数
2	筋萎縮性側索硬化症	2

2. 筋萎縮性側索硬化症

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臨床試験数 : 645 /  薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2020-005971-11-DE (EUCTR)	22/12/2021	11/06/2021	A Phase 2a study to evaluate, safety, tolerability, pharmacodynamic markers, and pharmacokinetics of AP-101 in patients with amyotrophic lateral sclerosis (ALS)	A Phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, pharmacodynamic markers, and pharmacokinetics of AP-101 in patients with familial amyotrophic lateral sclerosis (fALS) and sporadic amyotrophic lateral sclerosis (sALS)	Amyotrophic Lateral Sclerosis (ALS) MedDRA version: 21.1;Level: PT;Classification code 10002026;Term: Amyotrophic lateral sclerosis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: AP-101 Product Code: AP-101 INN or Proposed INN: Not yet available Other descriptive name: Anti-(misfolded human superoxide dismutase 1) human IgG1m3 monoclonal antibody	AL-S Pharma, AG	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	63	Phase 2	United States;Canada;Germany;Sweden;Korea, Republic of
2	NCT03981536 (ClinicalTrials.gov)	October 10, 2019	30/5/2019	A Study to Evaluate AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS)	A Multicenter, Open Label, Single-Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of AP-101 in Familial and Sporadic Amyotrophic Lateral Sclerosis (ALS)	Amyotrophic Lateral Sclerosis	Drug: AP-101	AL-S Pharma	NULL	Active, not recruiting	18 Years	N/A	All	18	Phase 1	Canada