127. 前頭側頭葉変性症 Frontotemporal lobar degeneration Clinical trials / Disease details
臨床試験数 : 90 / 薬物数 : 87 - (DrugBank : 30) / 標的遺伝子数 : 39 - 標的パスウェイ数 : 88
| 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 | EUCTR2021-005733-16-ES (EUCTR) | 19/07/2022 | 12/05/2022 | A 3 Part first-in-human study of DNL593 in healthy volunteers and patients with frontotemporal dementia (FTD) | A Phase 1/2, Multicenter, Randomized, Placebo-Controlled, Double-Blind Single Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia Followed by an Open-Label Extension - Part B, C of first in human study of DNL593 in healthy volunteers & FTD patients | Frontotemporal Dementia (FTD) MedDRA version: 21.1;Level: PT;Classification code 10068968;Term: Frontotemporal dementia;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: DNL593 Sterile Lyophilisate Product Code: DNL593 INN or Proposed INN: N/A Other descriptive name: DNL593 | Denali Therapeutics Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 40 | Phase 1;Phase 2 | United States;Portugal;Serbia;Czechia;Spain;Turkey;Colombia;United Kingdom;Italy;France;Argentina;Brazil;Belgium;Netherlands;Sweden | ||
| 2 | NCT05262023 (ClinicalTrials.gov) | February 1, 2022 | 1/2/2022 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia (FTD-GRN) | A Phase 1/2, Multicenter, Randomized, Placebo-Controlled, Double Blind Single Dose and Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL593 in Healthy Participants and Participants With Frontotemporal Dementia Followed by an Open-Label Extension | Frontotemporal Dementia | Drug: DNL593;Drug: Placebo | Denali Therapeutics Inc. | Takeda | Recruiting | 18 Years | 80 Years | All | 106 | Phase 1/Phase 2 | Netherlands;Spain;Turkey;United Kingdom |