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Experimental drug ALMB-0166 tested in spinal cord injury patients

NCT ID NCT05524103

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested a single dose of an experimental drug called ALMB-0166 in 24 people with acute spinal cord injury. The main goal was to check safety and how the drug moves through the body. Participants had moderate to severe injuries and were scheduled for surgery within 72 hours. Results will help decide if further studies are warranted.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ALMB-0166 (an experimental drug given as a single injection)
What this could lead to
If this drug is safe and shows promise, it could point toward a treatment that helps limit damage after a spinal cord injury.
What could go wrong
This is a very early phase 1 trial with only 24 participants, focused on safety, not effectiveness. The drug may not work or could have side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

24 people

The number who actually took part.

Started

Apr 2022

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Peking University Third Hospital

    Beijing, Beijing Municipality, China

  • Peking University Third Hospital Medical Science Research Ethic Committee

    Beijing, Beijing Municipality, 100191, China

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