Acute Spinal Cord InjuryPhase 1NCT05524103
Study to Evaluate the Safety and Pharmacokinetics of ALMB-0166 in Patients With Acute Spinal Cord Injury
A Phase 1 study testing ALMB-0166 in people with Acute Spinal Cord Injury, run by AlaMab Therapeutics (Shanghai) Inc. at 2 sites in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Spinal Cord Injury
- What is being tested?
- ALMB-0166
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesChina
- Study dates
- 15 Apr 2022to 8 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Peking University Third Hospital Medical Science Research Ethic Committee
Beijing, Beijing Municipality, 100191
Peking University Third Hospital
Beijing, Beijing Municipality
About this study
Official title: 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
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.
- Conditions
- Acute Spinal Cord Injury
- Being tested
- ALMB-0166
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALMB-0166Drug
Also called ALMB 0166
A single dose of ALMB-0166 injection.
| Study group | Role | What they receive |
|---|---|---|
| ALMB-0166 | Experimental | Two-thirds of patients will be randomized to receive a single dose of ALMB-0166 within 72 hours after spinal cord injury. Receives: Drug: ALMB-0166 |
| Placebo | Placebo comparator | One-third of patients will be randomized to receive a single dose of placebo within 72 hours after spinal cord injury. Receives: Drug: ALMB-0166 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events of ALMB0166 [Safety and Tolerability]
Assessment of the safety and tolerability of single dose of ALMB-0166
Measured: Up to 2 months post-dose
Secondary outcomes (4)
Maximum Plasma Concentration [Cmax] of ALMB0166
Assessment of pharmacokinetic (PK) profile
Measured: Pre-dose and multiple timepoints up to 2 months post-dose
Assessment of anti-drug antibodies (ADA)
Assessment of anti-drug antibodies (ADA)
Measured: Pre-dose and multiple timepoints up to 2 months post-dose
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.
Measured: Up to 2 months post-dose
Assessment of Short-form Visual Analogue Scale (VAS)
Scoring range: 0-10 points. Higher scores mean a worse outcome
Measured: Up to 2 months post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start15 Apr 2022
- Primary completion8 Feb 2025
- Study completion8 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- AlaMab Therapeutics (Shanghai) Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tian Jiali, Doctor, Principal investigator, Peking Union Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524103
- Sponsor's protocol ID
- ALMB-0166-CN-101
- Status last verified
- Aug 2022
- First submitted
- 26 Aug 2022
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05524103
- Acronym / sponsor ID
- ALMB-0166-CN-101
- Conditions
- Acute Spinal Cord Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- AlaMab Therapeutics (Shanghai) Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Apr 2022 (actual)
- Primary completion
- 8 Feb 2025 (actual)
- Study completion
- 8 Feb 2025 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALMB-0166 | Experimental | Drug: ALMB-0166Two-thirds of patients will be randomized to receive a single dose of ALMB-0166 within 72 hours after spinal cord injury. |
| Placebo | Placebo comparator | Drug: ALMB-0166One-third of patients will be randomized to receive a single dose of placebo within 72 hours after spinal cord injury. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (15 listed)
- 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℃.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALMB-0166Also: ALMB 0166A single dose of ALMB-0166 injection. | Drug | ALMB-0166, Placebo |
Primary outcome
Incidence of Treatment-Emergent Adverse Events of ALMB0166 [Safety and Tolerability]
Time frame: Up to 2 months post-dose
Assessment of the safety and tolerability of single dose of ALMB-0166
4 secondary outcomes
Maximum Plasma Concentration [Cmax] of ALMB0166
Time frame: Pre-dose and multiple timepoints up to 2 months post-dose
Assessment of anti-drug antibodies (ADA)
Time frame: Pre-dose and multiple timepoints up to 2 months post-dose
Assessment of American Spinal Cord Injury Association (ASIA) sensory, motor and injury grading.
Time frame: Up to 2 months post-dose
Assessment of Short-form Visual Analogue Scale (VAS)
Time frame: Up to 2 months post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tian Jiali, Doctor principal investigator
Peking Union Medical College
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ALMB-0166 in people with Acute Spinal Cord Injury, run by AlaMab Therapeutics (Shanghai) Inc. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events of ALMB0166 [Safety and Tolerability] (time frame: Up to 2 months post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.