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Safety and Tolerability of PNT001 in Patients With Acute Traumatic Brain Injury (TBI)

NCT04677829 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-06-29

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

PNT001

30 minute infusion for PNT001 1000mg; 60 minute infusion for PNT001 4000mg

BIOLOGICAL

%5 dextrose for infusion

30 min placebo infusion for 1000mg; 60 minute placebo infusion for 4000mg

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Pinteon Therapeutics, Inc

    lead INDUSTRY

Principal Investigators

  • Larry Altstiel, MD, PhD · Pinteon Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-29
Primary Completion
2021-04-12
Completion
2021-04-12
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04677829 on ClinicalTrials.gov