Study to Evaluate the Safety and Pharmacokinetics of ALMB-0166 in Patients With Acute Spinal Cord… (NCT05524103) | Clinical Trial Compass
CompletedPhase 1
Study to Evaluate the Safety and Pharmacokinetics of ALMB-0166 in Patients With Acute Spinal Cord Injury
China24 participantsStarted 2022-04-15
Plain-language summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of ALMB-0166 in patients with acute spinal cord injury.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events of ALMB0166 [Safety and Tolerability]