NCT05524103已完成1 期
A Phase Ⅰ, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ALMB-0166 in Patients With Acute Spinal Cord Injury
AlaMab Therapeutics (Shanghai) Inc.2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2022年4月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Incidence of Treatment-Emergent Adverse Events of ALMB0166 [Safety and Tolerability]
研究概览
简要总结
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ALMB-0166 in patients with acute spinal cord injury.
详细描述
This is a phase 1, randomized, double-blinded, placebo-controlled, single ascending dose study to evaluate the safety, tolerability and pharmacokinetics of ALMB-0166 in patients with acute spinal cord injury.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18-75 years old.
- •ASIA (American Spinal Injury Association) impairment scale grade B or C.
- •Spinal cord injury at the cervical and thoracic level (C4-T12).
- •Scheduled to undergo a spinal surgery within 72 hours after the initial injury.
- •Acute spinal cord injury that requires surgery as judged by the investigator.
- •Ability to understand the entire process of this study, voluntarily participate and sign written informed consent form.
- •Female patients with childbearing potential must have a negative serum pregnancy test and must be non-lactating. Male patients with female partners of childbearing age and female patients in childbearing age must use a medically approved contraceptive method during the study period and for 3 months after the administration. Male patients must avoid donating sperm during the study period.
排除标准
- •Surgical treatment is not necessary or impossible according to the judgment of the investigator or for other reasons.
- •Penetrating spinal cord injury or complete spinal cord rupture.
- •Accompanying traumatic brain injury (TBI) with visible structural lesions or diagnostic images, such as intracranial hemorrhage.
- •Patients with acute and chronic diseases that have caused neurological deficits (e.g., multiple sclerosis, Guillain-Barré syndrome, etc.)
- •Body temperature is lower than 35℃.
- •Patients with hemoglobin level <90 g/L.
- •Difficulty in completing the study due to coma, mental illness or other reasons.
- •History of drug abuse or dependence.
- •Allergies to macromolecular drugs or a previous history of severe drug allergies.
- •Positive serology for HIV and syphilis or active Hepatitis B or Hepatitis C.
- •History of serious diseases of other organ systems such as heart, lungs, liver, or kidneys, who are judged by the investigator to be unsuitable to participate in clinical trials; for example, cardiovascular disease such as New York Heart Association (NYHA) Grade II or higher congestive heart failure, unstable angina pectoris, myocardial infarction, etc., and pulmonary fibrosis or interstitial lung disease, etc. within 6 months before the administration.
- •Patients with active malignant tumour, or a history of treatment for invasive tumours within 3 years. Patients with stage I tumours who have received definite local treatments and are considered unlikely to recur can be accepted. Patients with a history of treatment for carcinoma in situ (such as non-invasive) and a history of non-melanoma skin cancer can be accepted.
- •Participated in other clinical trials and received drug treatment within 30 days before enrolment.
- •Patients with contraindications to lumbar puncture.
- •Any other issue which, in the opinion of the investigator, made the patient unsuitable for study participation.
研究组 & 干预措施
ALMB-0166
Experimental
Two-thirds of patients will be randomized to receive a single dose of ALMB-0166 within 72 hours after spinal cord injury.
干预措施: ALMB-0166 (Drug)
Placebo
Placebo Comparator
One-third of patients will be randomized to receive a single dose of placebo within 72 hours after spinal cord injury.
干预措施: ALMB-0166 (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events of ALMB0166 [Safety and Tolerability]
时间窗: Up to 2 months post-dose
Assessment of the safety and tolerability of single dose of ALMB-0166
次要结局
- Maximum Plasma Concentration [Cmax] of ALMB0166(Pre-dose and multiple timepoints up to 2 months post-dose)
- Assessment of anti-drug antibodies (ADA)(Pre-dose and multiple timepoints up to 2 months post-dose)
- Assessment of American Spinal Cord Injury Association (ASIA) sensory, motor and injury grading.(Up to 2 months post-dose)
- Assessment of Short-form Visual Analogue Scale (VAS)(Up to 2 months post-dose)
研究者
研究点 (2)
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