None listed
Conditions
Brief summary
This is a 15-day, single-blind, placebo-controlled study intended to assess the safety and tolerability as well as pharmacokinetics of the food product, AXA3359 administered over 8 days in adult participants with mild traumatic brain injury (mTBI). Up to 30 participants will be enrolled and randomised to receive either AXA3359 or matched placebo at a 2:1 ratio respectively. Participants will receive their first administration of study product within 24 hours of a mTBI and will receive a total of 3 study product administrations on the first study day regardless of food. On Days 2-7 participants will received study product twice daily 30 minutes before breakfast and dinner respectively. On Day 8, participants will have blood samples collected before and after administration to assess the pharmacokinetic properties of AXA3359. Safety follow up will extend to 15 days post first dose.
Interventions
Participants will be randomised to receive either 51.3g of active food product (AXA3359) or matched placebo per administration at a 2:1 ratio respectively; a total of 16 administrations over 8 Days. The amount of study product per administration may be reduced based on ongoing safety data. AXA3359/ placebo will be dissolved in 350 ml water for consumption. Participants will receive their first administration of study product within 24hrs of a concussion/ mild Traumatic Brain Injury at the study
Participants will be randomised to receive either 51.3g of active food product (AXA3359) or matched placebo per administration at a 2:1 ratio respectively; a total of 16 administrations over 8 Days. The amount of study product per administration may be reduced based on ongoing safety data. AXA3359/ placebo will be dissolved in 350 ml water for consumption. Participants will receive their first administration of study product within 24hrs of a concussion/ mild Traumatic Brain Injury at the study centre. The 2nd administration will then be 1-3 hours after the first at the study centre. Participants will then be sent home with sufficient study product to self administer for their 3rd administration on Day 1 either before dinner or at bedtime whichever is sooner; and twice daily, before breakfast and dinner, on Days 2 -7. On Day 8 participants will return to the study centre and will received a single administration of study product before breakfast. Adherence will be monitored via study product accountability by study personnel, and by review of the participant diary by study personnel in person with the participant on Day 8. Adherence will also be discussed with the participant either at the study centre or by phone on Days 2, 3, 4, 5, and 7. Blood samples will be collected on Day 1 and on Day 8 to assess blood levels of study product to assist with adherence.
Sponsors
Axcella Health Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
1. Males or females aged 18-35 years (inclusive) 2. Body Mass Index < 32 kg/m2 3. Confirmed medical diagnosis of concussion/mTBI from a study investigator within 24 hours or less of the injury event. 4. Otherwise in generally good health, and be nonsmokers and abstain from any alcohol use for the duration of the study. 6. A Brain Function Index (BFI) of <= 40 percentile
Exclusion criteria
1. Individuals with any clinically significant or unstable medical conditions, other than mTBI, requiring acute intervention. 2. Individuals with a concussion or a prior concussion or hospitalization for a head injury within 60 days 4. Any head trauma that is considered “moderate” or “severe” by the study investigator as measured by Glasgow Coma Scale (GCS) score of <13 within 24 hours of injury. 15. Receipt of an investigational drug or any investigational dietary supplement/food product (including, but not limited to creatine, Lacetyl carnitine, N-acetyl cysteine, any amino acids, protein drinks, fish oils, etc.), or participation in a trial of an investigational device within 1 month (or 5 half-lives), whichever is longer, before Screening.
Outcome results
None listed