Study to Evaluate the Safety and Pharmacokinetics of ALMB-0166 in Patients With Acute Spinal Cord Injury

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ALMB-0166 in patients with acute spinal cord injury.

Detailed Description
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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.

Official Title
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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

Conditions
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Acute Spinal Cord Injury

Intervention / Treatment
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* Drug: ALMB-0166


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ALMB-0166<br>Two-thirds of patients will be randomized to receive a single dose of ALMB-0166 within 72 hours after spinal cord injury. | Drug: ALMB-0166<br>* A single dose of ALMB-0166 injection.<br>* Other names: ALMB 0166;|
| Placebo Comparator: Placebo<br>One-third of patients will be randomized to receive a single dose of placebo within 72 hours after spinal cord injury. | Drug: ALMB-0166<br>* A single dose of ALMB-0166 injection.<br>* Other names: ALMB 0166;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events of ALMB0166 [Safety and Tolerability] | Assessment of the safety and tolerability of single dose of ALMB-0166 | Up to 2 months post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Plasma Concentration [Cmax] of ALMB0166 | Assessment of pharmacokinetic (PK) profile | Pre-dose and multiple timepoints up to 2 months post-dose | 
| Assessment of anti-drug antibodies (ADA) | 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. | Sensory score range: 0-224 points; Sports score range: 0-100 points; Classification range: A-E. Higher scores mean a better outcome. | Up to 2 months post-dose | 
| Assessment of Short-form Visual Analogue Scale (VAS) | Scoring range: 0-10 points. Higher scores mean a worse outcome | Up to 2 months post-dose |