Status:
TERMINATED
Safety and Tolerability of PNT001 in Patients With Acute Traumatic Brain Injury (TBI)
Lead Sponsor:
Pinteon Therapeutics, Inc
Collaborating Sponsors:
United States Department of Defense
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
This is a Phase 1, multi-center, randomized, double-blind, placebo-controlled, multiple-ascending- dose trial to evaluate the safety, tolerability, immunogenicity, and pharmacokinetics of intravenous ...
Detailed Description
The Phase 1 study is a double-blind, multiple ascending dose trial evaluating a total of 64 patients across two dose cohort groups. Each cohort will include 32 patients (24 active; 8 placebo) who will...
Eligibility Criteria
Inclusion
- Hospitalization due to documented evidence of TBI with Glasgow Coma Scale (GCS) Score 9-12 or GCS score of 13-15 with radiographic evidence of trauma.
- Duration from documented time of TBI event to time of start of initial dose of study drug will not exceed 24 hours.
- Signed informed consent by patient, or where applicable, patient's legally authorized representative.
- Male and females, 18- 65 years of age at time of screening (State's legal age of majority is minimum age if higher than 18).
- Female patients must meet protocol defined criteria for 1) non-childbearing potential, 2) post menopausal or 3) must have a negative pregnancy test and agree to contraception as outlined in the protocol.
- Male must agree to use acceptable contraception and refrain from sperm donation during the entire study and for 200 days after dosing has been completed.
- Has not participated in a clinical drug trial within 3 months of study start.
- Body Mass Index (BMI) of 18.5-35.0 kg/m2 and for the 4000mg dose group only, weight greater than or equal to 44.8 kg.
- Vision, hearing, speech, motor function, and comprehension sufficient for compliance with all testing procedures and assessments.
Exclusion
- TBI that does not require hospitalization.
- TBI outside 24-hour window.
- GCS \< 9 within 2 hours of dosing.
- History of TBI in past 12 months that resulted in patient seeking medical attention.
- Evidence of penetrating head trauma or depressed skull fracture.
- Clinical or radiographic evidence of mass effect, midline shift, or intracranial hypertension, requiring craniotomy/craniectomy.
- Evidence of symptomatic cervical, thoracic, lumbar spine injury e.g. paresis, radiculopathy, that can be localized to the injury.
- Systemic traumatic injury that would preclude participation in study or is expected to result in long-term disability.
- Any other acute or chronic medical illness that in the judgement of the study physician results in functional impairment or impairs neuropsychiatric function.
- Any acute intoxication that in the judgement of the study physician results in significant functional impairment or impairs neuropsychiatric function.
- Any history of cancer within 5 years of enrollment with the exception of resected skin basal cell carcinoma.
- Any major surgery requiring general anesthesia within 4 weeks of study drug administration.
- Donation of blood or serum ≥500 mL to a blood bank or in a clinical study (except screening visit) within 3 months of study drug administration.
- Known recent (within 6 months of study drug administration) drug or alcohol abuse as defined in DSM V, Diagnostic Criteria for Drug and Alcohol Abuse.
- Evidence of any clinically significant neurological or psychiatric disorder that could interfere with study assessments as determined by investigator and sponsor.
- Patient has history or currently has schizophrenia, schizoaffective disorder or bipolar disorder, untreated major depression (DSM-V or ICD-10 criteria).
- Significant illness within the prior 30 days.
- Abnormalities in creatinine, hepatic transaminases, or QT that would preclude entry into the study.
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2021
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT04677829
Start Date
March 29 2021
End Date
April 12 2021
Last Update
June 29 2022
Active Locations (1)
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1
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104