A Phase 1 interventional study of ALMB-0166 in Acute Spinal Cord Injury, sponsored by AlaMab Therapeutics (Shanghai) Inc.. Completed at 2 sites in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by AlaMab Therapeutics (Shanghai) Inc. · Phase 1, Interventional, and Treatment
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.
AlaMab Therapeutics (Shanghai) Inc. is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
One-third of patients will be randomized to receive a single dose of placebo within 72 hours after spinal cord injury.
Drug: ALMB-0166
A single dose of ALMB-0166 injection.
Also known as: ALMB 0166
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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AlaMab Therapeutics (Shanghai) Inc.