VIS649 ( DrugBank: - )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
66IgA腎症3

66. IgA腎症


臨床試験数 : 255 薬物数 : 255 - (DrugBank : 79) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 137
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1NCT04287985
(ClinicalTrials.gov)
July 20, 202010/2/2020Safety and Efficacy Study of VIS649 for IgA NephropathyA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants With Immunoglobulin A (IgA) NephropathyImmunoglobulin A Nephropathy;Glomerular Disease;IgANDrug: Dose-Placebo;Drug: Low Dose-VIS649;Drug: Medium Dose-VIS649;Drug: High Dose-VIS649Visterra, Inc.NULLRecruiting18 YearsN/AAll144Phase 2United States;Australia;Canada;Hong Kong;India;Japan;Korea, Republic of;Malaysia;Philippines;Singapore;Spain;Sri Lanka;Taiwan;Thailand;United Kingdom
2EUCTR2019-002531-29-GB
(EUCTR)
24/03/202017/12/2019A study to look at the effect and how safe drug VIS649 is in patients with kidney diseaseA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants with Immunoglobulin A (IgA) Nephropathy Immunoglobulin A (IgA) Nephropathy
MedDRA version: 20.0;Level: PT;Classification code 10021263;Term: IgA nephropathy;System Organ Class: 10038359 - Renal and urinary disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: VIS649
Product Code: VIS649
INN or Proposed INN: VIS649
Other descriptive name: VIS649
Product Name: VIS649
Product Code: VIS649
INN or Proposed INN: VIS649
Other descriptive name: VIS649
Product Name: VIS649
Product Code: VIS649
INN or Proposed INN: VIS649
Other descriptive name: VIS649
Visterra, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
144Phase 2United States;Philippines;Hong Kong;Taiwan;Thailand;Spain;United Kingdom;India;Czech Republic;Canada;Malaysia;Singapore;Australia;Japan;Korea, Republic of
3NCT03719443
(ClinicalTrials.gov)
October 9, 201810/10/2018First in Human Study to Assess Safety of VIS649 in Healthy SubjectsA Phase 1, Randomized, Placebo-Controlled, Single Ascending Dose First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VIS649 Administered Intravenously in Healthy SubjectsImmunoglobulin A Nephropathy;IgAN - IgA Nephropathy;IgA NephropathyBiological: VIS649;Biological: PlaceboVisterra, Inc.NULLCompleted18 Years55 YearsAll41Phase 1United States