CTIS2024-510895-18-00进行中（未招募）1 期
(ASK-HD-01-CS-101) An Open-Label Phase I/II Dose Finding Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of Striatal Administration of AB-1001 in Adult Subjects with Early Manifest Huntington’s Disease (HD) - ASK-HD-01-CS-101
Brainvectis0 个研究点目标入组 18 人开始时间: 2024年2月29日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Male or Female subjects between ages 18 and 65 years (both inclusive) at time of consenting, able to provide Informed Consent and able to understand and comply with all study procedures., Documented genetic confirmation of pathological CAG expansion in the huntingtin gene = 40, Early manifest HD as defined by a UHDRS total functional capacity (TFC) score of 9 to 13 and a diagnostic classification level (DCL) of 4, or a DCL of 3 if present with cognitive impairment and clear evidence of disease progression., Striatal MRI volumes per hemisphere compatible with the local delivery of the study drug: Putamen = 2.3 cm3 (per side); Caudate = 1.7 cm3 on Screening MRI., All HD concomitant medications are stable for at least 30 days prior to screening at the investigator’s discretion.
排除标准
- •Subjects with prior metastatic neoplasms, Subjects with active psychosis, Subjects with confused state, Subjects with violent and/or suicidal behavior, Subjects with prior strokes, Subjects with intracranial hemorrhage, Subjects with active infection, Subjects with contraindication to MRI or gadolinium and any other medical condition that in the investigator’s opinion would interfere with the study conduct and assessments will be excluded.
研究者
相似试验
已完成
1 期
A PHASE 1, OPEN-LABEL, DOSE-FINDING STUDY TO ASSESS THE SAFETY, TOLERABILITY, PHARMACOKINETICS AND PRELIMINARY EFFICACY OF CC-90010 IN SUBJECTS WITH ADVANCED SOLID TUMORS AND RELAPSED/REFRACTORY NONHODGKIN LYMPHOMASJPRN-jRCT2080225176Bristol-Myers Squibb6
招募中
1 期
A Open Label, Dose-Escalation study evaluating the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of AUR103 Calcium in patients with relapsed advanced malignanciesCTRI/2024/04/065493Aurigene Oncology Limited
进行中（未招募）
1 期
Phase I/II Safety and Tolerability Study of striatal administration of BV-101 in adult subjects with Early Manifest Huntington's Disease (HD)Huntington's diseaseMedDRA version: 20.0Level: PTClassification code 10070668Term: Huntington's diseaseSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2021-003052-16-FRBrainvectis18
进行中（未招募）
1 期
A Study Of Phase I dose escalation trial of ZYIL1 Via Oral Route To Investigate The Safety, Tolerability, Pharmacokinetics And Pharmacodynamics In Healthy Adult Human SubjectsCTRI/2020/12/030045Cadila Healthcare Ltd
进行中（未招募）
1 期
An open label, Phase Ia/Ib dose finding study with BI 894999 orally administered once a day in patients with advanced malignancies, with repeated administration in patients with clinical benefit - BI 894999 first in human dose finding study in advanced malignanciesAdvanced, unresectable and/or metastatic solid tumours, which have failed with conventional treatment or for which no therapy of proven efficacy exists, or in patients who are not amenable to standard therapies and patients with diffuse large B-cell lymphoma (DLBCL) for whom there are limited or no standard treatment options availableMedDRA version: 20.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10012820Term: Diffuse large B-cell lymphoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10041067Term: Small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10010029Term: Colorectal cancer NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10076506Term: Castration-resistant prostate cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10078295Term: NUT midline carcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-001111-12-BESCS Boehringer Ingelheim Comm.V158