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CompletedNCT05524103Updated Nov 18, 2025

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

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

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Apr 2022, registered Aug 2022).
Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Acute Spinal Cord Injury
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In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    ALMB-0166

    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

  • Placebo comparator
    Placebo

    One-third of patients will be randomized to receive a single dose of placebo within 72 hours after spinal cord injury.

    Drug: ALMB-0166

Interventions

  • DrugALMB-0166

    A single dose of ALMB-0166 injection.

    Also known as: ALMB 0166

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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Maximum Plasma Concentration [Cmax] of ALMB0166

    Assessment of pharmacokinetic (PK) profile

    Time frame: Pre-dose and multiple timepoints up to 2 months post-dose

  2. 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

  3. 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

  4. 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

07

Study locations

2 sites
  • Peking University Third Hospital Medical Science Research Ethic Committee
    Beijing, Beijing Municipality 100191, China
  • Peking University Third Hospital
    Beijing, Beijing Municipality, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05524103
Lead sponsor
AlaMab Therapeutics (Shanghai) Inc.
Responsible party
Sponsor
First posted
Sep 1, 2022
Start date
Apr 15, 2022
Primary completion
Feb 8, 2025
Completion
Feb 8, 2025
Last update
Nov 18, 2025

Study contacts

Tian Jiali, Doctor
principal investigator · Peking Union Medical College

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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