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Study to Evaluate the Safety and Pharmacokinetics of ALMB-0166 in Patients With Acute Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05524103
Recruitment Status : Recruiting
First Posted : September 1, 2022
Last Update Posted : September 1, 2022
Sponsor:
Information provided by (Responsible Party):
AlaMab Therapeutics (Shanghai) Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Spinal Cord Injury Drug: ALMB-0166 Phase 1

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : April 15, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: ALMB-0166
Two-thirds of patients will be randomized to receive a single dose of ALMB-0166 within 72 hours after spinal cord injury.
 Drug: ALMB-0166
A single dose of ALMB-0166 injection.
Other Name: ALMB 0166
Placebo Comparator: Placebo
One-third of patients will be randomized to receive a single dose of placebo within 72 hours after spinal cord injury.
 Drug: ALMB-0166
A single dose of ALMB-0166 injection.
Other Name: ALMB 0166


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Maximum Plasma Concentration [Cmax] of ALMB0166 [ Time Frame: Pre-dose and multiple timepoints up to 2 months post-dose ]
    Assessment of pharmacokinetic (PK) profile

  2. Assessment of anti-drug antibodies (ADA) [ Time Frame: Pre-dose and multiple timepoints up to 2 months post-dose ]
    Assessment of anti-drug antibodies (ADA)

  3. Assessment of American Spinal Cord Injury Association (ASIA) sensory, motor and injury grading. [ Time Frame: 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.

  4. Assessment of Short-form Visual Analogue Scale (VAS) [ Time Frame: Up to 2 months post-dose ]
    Scoring range: 0-10 points. Higher scores mean a worse outcome


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05524103


Contacts
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Contact: Du Peng, PD 13871292525 dupeng@mail.ecspc.com

Locations
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China, Beijing
Peking University Third Hospital Medical Science Research Ethic Committee Recruiting
Beijing, Beijing, China, 100191
Contact: Hong Teacher, Doctor    010-82265571      
Peking University Third Hospital Recruiting
Beijing, Beijing, China
Sponsors and Collaborators
AlaMab Therapeutics (Shanghai) Inc.
Investigators
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Principal Investigator: Tian Jiali, Doctor Peking Union Medical College
More Information
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Responsible Party: AlaMab Therapeutics (Shanghai) Inc.
ClinicalTrials.gov Identifier: NCT05524103    
Other Study ID Numbers: ALMB-0166-CN-101
First Posted: September 1, 2022    Key Record Dates
Last Update Posted: September 1, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System