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

Drug

General health

Online since 7 February 2023, updated 437 days ago

About this trial

This trial is enrolling individuals with acute (less than 72 hours), incomplete cervical and thoracic spinal cord injuries to test the safety, tolerability and overall activity in the body (pharmacokinetics) of an experimental drug (ALMB-0166). The drug is believed to reduce local inflammation and scar formation, thus improving nerve growth and recovery. If included, participants will either receive a single dose of: 1) the active drug; or 2) a placebo (inactive) drug. Outcomes will be followed for up to 2 months.

Included participants

Gender

All

Age

18 - 75 years

Injury level

C4 - T12

Severity (AIS)?

AIS-B

AIS-C

Time since injury

≤ 72 null

Healthy volunteers

C4-T12

Additionally, participants must

be scheduled to undergo a spinal surgery within 72 hours after initial injury.

What’s involved

Type

Drug

Details

Participants will either receive a single dose of 1) the active drug or 2) the placebo within 72 hours after injury.

Potential benefits

Main benefits

General health

Additional benefits

Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

Wings for Life supports SCITrialsFinder

Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

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