Study to Evaluate the Safety and Pharmacokinetics of ALMB-0166 in Patients With Acute Spinal Cord Injury
- Registration Number
- NCT05524103
- Lead Sponsor
- AlaMab Therapeutics (Shanghai) Inc.
- Brief Summary
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 45
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ALMB-0166 ALMB-0166 Two-thirds of patients will be randomized to receive a single dose of ALMB-0166 within 72 hours after spinal cord injury. Placebo ALMB-0166 One-third of patients will be randomized to receive a single dose of placebo within 72 hours after spinal cord injury.
- Primary Outcome Measures
Name Time Method Incidence of Treatment-Emergent Adverse Events of ALMB0166 [Safety and Tolerability] Up to 2 months post-dose Assessment of the safety and tolerability of single dose of ALMB-0166
- Secondary Outcome Measures
Name Time Method Maximum Plasma Concentration [Cmax] of ALMB0166 Pre-dose and multiple timepoints up to 2 months post-dose Assessment of pharmacokinetic (PK) profile
Assessment of anti-drug antibodies (ADA) Pre-dose and multiple timepoints up to 2 months post-dose Assessment of anti-drug antibodies (ADA)
Assessment of American Spinal Cord Injury Association (ASIA) sensory, motor and injury grading. Up to 2 months post-dose Sensory score range: 0-224 points; Sports score range: 0-100 points; Classification range: A-E. Higher scores mean a better outcome.
Assessment of Short-form Visual Analogue Scale (VAS) Up to 2 months post-dose Scoring range: 0-10 points. Higher scores mean a worse outcome
Trial Locations
- Locations (2)
Peking University Third Hospital Medical Science Research Ethic Committee
🇨🇳Beijing, Beijing, China
Peking University Third Hospital
🇨🇳Beijing, Beijing, China