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

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Spinal Cord Injury
• Intervention / Treatment: Drug: ALMB-0166

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 Type: Interventional
• Enrollment (Anticipated): 45
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Du Peng, PD; Phone Number: 13871292525; Email: dupeng@mail.ecspc.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital Medical Science Research Ethic Committee
      • Contact: Hong Teacher, Doctor; Phone Number: 010-82265571

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: ALMB 0166

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Treatment-Emergent Adverse Events of ALMB0166 [Safety and Tolerability]	Assessment of the safety and tolerability of single dose of ALMB-0166	Up to 2 months post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration [Cmax] of ALMB0166	Assessment of pharmacokinetic (PK) profile	Pre-dose and multiple timepoints up to 2 months post-dose
Assessment of anti-drug antibodies (ADA)	Assessment of anti-drug antibodies (ADA)	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.	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	Up to 2 months post-dose

Collaborators and Investigators

• Sponsor: AlaMab Therapeutics (Shanghai) Inc.
• Investigators: Principal Investigator: Tian Jiali, Doctor, Peking Union Medical College

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: August 26, 2022
• First Submitted That Met QC Criteria: August 29, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): September 1, 2022
• Last Update Submitted That Met QC Criteria: August 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: ALMB-0166-CN-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No