AP-101 ( DrugBank: - )


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


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.TrialIDDate_
enrollment
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registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
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sponsor
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Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2020-005971-11-DE
(EUCTR)
22/12/202111/06/2021A 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, AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
63Phase 2United States;Canada;Germany;Sweden;Korea, Republic of
2NCT03981536
(ClinicalTrials.gov)
October 10, 201930/5/2019A 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 SclerosisDrug: AP-101AL-S PharmaNULLActive, not recruiting18 YearsN/AAll18Phase 1Canada