Experimental drug ALMB-0166 tested in spinal cord injury patients
NCT ID NCT05524103
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute spinal cord injury are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Spinal stimulation may tame blood pressure swings after injury
- Electric jolts to abdominal muscles may restore cough power after spinal injury
- New ultrasound method spots low blood flow in spinal cord injuries
- Spinal injury patients may keep stronger bones with simple infusion
- Diabetes drug shows promise for spinal cord injury in early trial
- Spinal zaps could stop dizziness after injury