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

NCT ID: NCT06096415

Last Updated: 2023-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-31
• Study Completion Date: 2024-05-31

Brief 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.

Detailed 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.

Conditions

Traumatic Brain Injury; Cerebral Edema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental: ABX-101 1mg

Participants will be screened, enrolled and receive the assigned treatment within 12 hours of the primary TBI insult (or estimated less than 12 hours if the exact time is unknown).

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.

Group Type: EXPERIMENTAL

ABX-101 1mg

Intervention Type: DRUG

ABX-101 1mg will be provided to patients stratified 1:1 by GCS scoring (GCS 4-8; GCS 9-12)

ABX-101 2mg

Intervention Type: DRUG

ABX-101 2mg will be provided to patients stratified 1:1 by GCS scoring (GCS 4-8; GCS 9-12)

Experimental: ABX-101 2mg

Participants will be screened, enrolled and receive the assigned treatment within 12 hours of the primary TBI insult (or estimated less than 12 hours if the exact time is unknown).

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.

Group Type: EXPERIMENTAL

ABX-101 1mg

Intervention Type: DRUG

ABX-101 1mg will be provided to patients stratified 1:1 by GCS scoring (GCS 4-8; GCS 9-12)

ABX-101 2mg

Intervention Type: DRUG

ABX-101 2mg will be provided to patients stratified 1:1 by GCS scoring (GCS 4-8; GCS 9-12)

Placebo Comparator: Saline

Placebo to the ABX-101 will be administered to patients.

Group Type: PLACEBO_COMPARATOR

ABX-101 1mg

Intervention Type: DRUG

ABX-101 1mg will be provided to patients stratified 1:1 by GCS scoring (GCS 4-8; GCS 9-12)

ABX-101 2mg

Intervention Type: DRUG

ABX-101 2mg will be provided to patients stratified 1:1 by GCS scoring (GCS 4-8; GCS 9-12)

Interventions

ABX-101 1mg

ABX-101 1mg will be provided to patients stratified 1:1 by GCS scoring (GCS 4-8; GCS 9-12)

Intervention Type: DRUG

ABX-101 2mg

ABX-101 2mg will be provided to patients stratified 1:1 by GCS scoring (GCS 4-8; GCS 9-12)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Written informed consent from patient, patient's legal guardian or legal representative, or deferred consent procedure, according to local requirements
• 18 - 50 years of age, inclusive
• Expected to survive more than 24 hours after admission
• Clearly defined time of injury no more than 12 hours before administration of study drug/placebo

o Subjects stratified 1:1 (in each arm) by treatment administered 0-12 hrs

• TBI with Glasgow Coma Score (GCS) 4-12 requiring intracranial pressure (ICP) monitoring according to the assessment of the treating physician

o Subjects stratified 1:1 (in each arm) by GCS 4-8 and GCS 9-12

• Catheter placement (intraventricular or intraparenchymal, only) for monitoring and management of increased ICP
• [Brain computed tomography (CT) showing intracranial parenchymal abnormality and hemodynamically stable]

Exclusion Criteria

• Penetrating head injury (e.g. missile, stab wound)
• Concurrent, but not pre-existing, spinal cord injury
• Not expected to survive more than 24 hours after admission
• Pregnant, or a positive pregnancy test
• Coma due to an exclusive epidural hematoma (lucid interval and absence of structural brain damage on CT scan)
• Patient pupils are unresponsive (dilation) in both eyes
• The subject has a neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors.
• Coma suspected to be primarily due to other causes than head injury (e.g. drug overdose intoxication, drowning/near drowning
• Known or CT scan evidence of pre-existing major cerebral damage
• Any severe concomitant condition (cancer; hematologic, renal, hepatic, coronary disease; major psychiatric disorder; alcohol or drug abuse), that can be ascertained at admission
• Known to have received an experimental drug within 4 weeks prior to current injury
• Patients who cannot be monitored with regard to their recovery (GOS-E and QOLIBRI)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abalonex, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

ABX-TBI-001

Identifier Type: -

Identifier Source: org_study_id