NCT07264270招募中1 期
A Phase 1, Randomized, Double-Blind, Single Dose Escalation Study to Assess the Safety and Tolerability of Transforaminal Epidural Administration of C-1101 Versus Sterile Saline in Adults With Chronic Painful Lumbosacral Radiculopathy
Consano Bio3 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年12月3日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 24
- 试验地点
- 3
- 主要终点
- Incidence and severity of treatment emergent adverse events (TEAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of C-1101 administered as a single dose, transforaminal epidural injection compared to sterile saline
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of painful LSR (sciatica) radiating to or below the knee, with an inadequate response to conservative care
- •Body mass index < 35 kg/m2.
排除标准
- •Presence of clinically significant disease or any other painful condition that may interfere with assessments.
- •Any condition that currently requires blood or platelet transfusions.
- •Diagnosed with schizophrenia, bipolar disorder, or major depressive disorder.
- •Increased risk of bleeding or is taking anticoagulants or platelet aggregation inhibitors.
- •History or presence of autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathies.
- •History of myocardial infarction within the last 6 months or congestive heart failure.
- •The presence of an active malignancy or tumor.
- •Have undergone a surgical procedure for back pain.
- •Recent use of immunosuppressants, oral steroids, or intravenous steroids.
研究组 & 干预措施
Cohort 1 - Low dose
Experimental
干预措施: C-1101 (Drug)
Cohort 2 - Mid dose
Experimental
干预措施: C-1101 (Drug)
Cohort 3 - High dose
Experimental
干预措施: C-1101 (Drug)
Cohort 3 - High dose
Experimental
干预措施: Placebo: Sterile Saline (Other)
Cohort 1 - Low dose
Experimental
干预措施: Placebo: Sterile Saline (Other)
Cohort 2 - Mid dose
Experimental
干预措施: Placebo: Sterile Saline (Other)
结局指标
主要结局
Incidence and severity of treatment emergent adverse events (TEAEs)
时间窗: From Day 1 to Week 24
Incidence and severity of adverse events of special interest (AESIs)
时间窗: From Day 1 to Week 24
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
相似试验
招募中
1 期
KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell LymphomaDiffuse Large B Cell Lymphoma (DLBCL)NCT07260812TCRx Therapeutics Co.Ltd18
招募中
1 期
Evaluation of the Safety, Tolerability and Pharmacokinetics of HY6725 in Healthy Adult ParticipantsNCT07262281Newsoara Biopharma Co., Ltd.74
招募中
1 期
Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid TumorsColorectal CancerNon-Small Cell Lung CancerNCT07261631Novartis Pharmaceuticals180
已完成
4 期
This is a study to evaluate dose-flexibility of Upadacitinib in Adult Subjects with Moderate to Severe Atopic Dermatitis2023-504869-23-00AbbVie Deutschland GmbH & Co. KG272
招募中
1 期
A Phase I Study Evaluating the Safety, Tolerability, and Pharmacokinetics of VVN432 Nasal SprayNCT07259538VivaVision Biotech, Inc60