The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ALMB-0166 in patients with acute spinal cord injury.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
24
A single dose of ALMB-0166 injection.
Peking University Third Hospital Medical Science Research Ethic Committee
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
Incidence of Treatment-Emergent Adverse Events of ALMB0166 [Safety and Tolerability]
Assessment of the safety and tolerability of single dose of ALMB-0166
Time frame: Up to 2 months post-dose
Maximum Plasma Concentration [Cmax] of ALMB0166
Assessment of pharmacokinetic (PK) profile
Time frame: Pre-dose and multiple timepoints up to 2 months post-dose
Assessment of anti-drug antibodies (ADA)
Assessment of anti-drug antibodies (ADA)
Time frame: 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.
Time frame: 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
Time frame: Up to 2 months post-dose
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