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Study to Evaluate the Safety and Pharmacokinetics of ALMB-0166 in Patients With Acute Spinal Cord Injury | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT05524103•AlaMab Therapeutics (Shanghai) Inc.

View on ClinicalTrials.gov

Summary

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

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

Locations (2)

Peking University Third Hospital Medical Science Research Ethic Committee

Beijing, Beijing Municipality, China

Peking University Third Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

April 15, 2022

Primary Completion Date

February 8, 2025

Completion Date

February 8, 2025

Last Updated

November 18, 2025

Enrollment

ACTUAL participants

Conditions

Acute Spinal Cord Injury

Interventions

ALMB-0166

DRUG

Contrast-enhanced Ultrasound in the Treatment of Acute Spinal Cord Injury

NCT06654804

Acute Spinal Cord Injury

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UNKNOWNPHASE2/PHASE3

Stem Cells in Spinal Cord Injury

NCT03935724

Spinal Cord InjuriesAcute Spinal Cord Injury+2 more

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UNKNOWN

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Contrast-enhanced Ultrasound in the Treatment of Acute Spinal Cord Injury

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