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Safety and Efficacy of ABX-101 in Participants Aged 18 to 50 Years of Age With Moderate to Severe Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

Official title:
A Parallel Group Treatment, Phase 2A, Double-blind, 3-arm Study to Investigate Safety and Efficacy of ABX-101 Compared With Placebo in Male and Female Participants, Aged 18 to 50 Years, With Moderate-to-severe Traumatic Brain Injury

Clinical Trial Summary

The purpose of this study is to investigate the clinical improvement measured by the Glasgow Outcome Scale Extended (GOS-E) with ABX-101 compared with Placebo intramuscular injection in participants with moderate to severe TBI.

Clinical Trial Description

Study details include: - The study duration will be up to 180 days per participant. - The treatment duration will be up to 7 days. - The visits post-treatment will be on day 30 and day 180 of the study. Number of Participants: A maximum of 45 participants will be enrolled into the study and randomized to each treatment arm in a ratio of 1:1:1. i.e., fifteen participants per arm. Study Arms and Duration: Participants will be screened, enrolled and receive the assigned treatment within 12 hours of the primary TBI insult. Enrolled participants will be stratified 1:1 (in each arm) by GCS score (GCS 4-8 in one group and GCS 9 - 12 in the other). The treatment period, which involves 6 hourly, i.e., quarter in die (QID), ABX-101 (1 mg OR 2 mg) intramuscular injections, is seven days. Enrolled participant will continue with the in-hospital standard of care, as decided by the external treating physician, and will be followed up by the study team on days 30 and days 180. The ABX-101 1 mg and 2 mg arm will be enrolled simultaneously. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06096415
Study type Interventional
Source Abalonex, LLC
Contact
Status Not yet recruiting
Phase Phase 2
Start date December 2023
Completion date May 2024
View Details
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