drugset / Trial / NCT04677829
Safety and Tolerability of PNT001 in Patients With Acute Traumatic Brain Injury (TBI)
Phase 1
Terminated
1 enrolled
Pinteon Therapeutics, Inc
United States Department of Defense · collab
RandomizedSequentialQuadruple-blindTreatment
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 PNT001 in hospitalized patients with traumatic brain injury.
Timeline
- Start
- 2021-03-29
- Primary completion
- 2021-04-12
- Completion
- 2021-04-12
Outcome
Outcome not reported
Stopped: “The study was terminated due to administrative, non-safety related reasons.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PNT001 | Unknown | 1000 mg | Intravenous |
| Subject | PNT001 | Unknown | 4000 mg | Intravenous |