Safety and Tolerability of PNT001 in Patients With Acute Traumatic Brain Injury (TBI)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Traumatic Brain Injury
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: Escalating dose level cohorts; each cohort with an active and a placebo armMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Masking Description: Study drug will be administered and assessed in double-blinded fashion.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 21 years and 65 years
- Gender
- Both males and females
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 be randomized to receive three doses of either PNT001 or placebo. Doses studied will be 1000mg and ...
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 be randomized to receive three doses of either PNT001 or placebo. Doses studied will be 1000mg and 2700mg. Patients admitted to the trauma center who meet entrance criteria will receive their first dose of study drug within 24 hours of documented TBI. They will remain in the facility for at least 2 nights. Baseline plasma and CSF biomarker collection and cognitive assessments will be completed. Study medication will be administered as an IV infusion over 30 minutes followed by collection of safety, tolerability, pharmacokinetic, biomarker, imaging, and cognitive data over 12 weeks. Once discharged, patients will be instructed to return for study visits. Subsequent visits for dosing will include a lumbar puncture (LP; Day 28) for pharmacokinetics (PK) and biomarkers followed by safety, PK, biomarker and clinical assessments.
Tracking Information
- NCT #
- NCT04677829
- Collaborators
- Not Provided
- Investigators
- Study Director: Larry Altstiel, MD, PhD Pinteon Therapeutics
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