NCT04677829 is a Phase 1 clinical trial of PNT001 in Traumatic Brain Injury, sponsored by Pinteon Therapeutics, Inc.

Who is sponsoring NCT04677829?

NCT04677829 is sponsored by Pinteon Therapeutics, Inc.

What drugs are being tested in NCT04677829?

Interventions in NCT04677829: PNT001, %5 dextrose for infusion.

What condition does NCT04677829 study?

NCT04677829 studies Traumatic Brain Injury.

Is NCT04677829 still recruiting?

NCT04677829 is currently terminated. Last updated 29 June 2022.

Last reviewed 2022-06-29 · How we verify

NCT04677829

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 1 Last updated 29 June 2022

What this trial tests

Phase 1 trial testing PNT001 in Traumatic Brain Injury in 1 participant. Terminated before completion.

Timeline

29 March 2021

Primary endpoint
12 April 2021

12 April 2021

Quick facts

Lead sponsor	Pinteon Therapeutics, Inc
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	1
Start date	29 March 2021
Primary completion	12 April 2021
Estimated completion	12 April 2021
Sites	1 location across United States

Drugs / interventions tested

PNT001 — full drug profile →
%5 dextrose for infusion — full drug profile →

Conditions studied

Traumatic Brain Injury — all drugs for Traumatic Brain Injury →

Sponsor

Pinteon Therapeutics, Inc — full company profile →

Who can join

Adults 18 to 65, any sex, with Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Tau-targeting therapies for Alzheimer disease: current status and future directions.
Congdon EE, Ji C, Tetlow AM, Jiang Y, et al · · 2023 · cited 246× · PMID 37875627 · DOI 10.1038/s41582-023-00883-2
"Don't Phos Over Tau": recent developments in clinical biomarkers and therapies targeting tau phosphorylation in Alzheimer's disease and other tauopathies.
Xia Y, Prokop S, Giasson BI. · · 2021 · cited 160× · PMID 34090488 · DOI 10.1186/s13024-021-00460-5
Current Status of Clinical Trials on Tau Immunotherapies.
Ji C, Sigurdsson EM. · · 2021 · cited 79× · PMID 34101156 · DOI 10.1007/s40265-021-01546-6
The Enigma of Tau Protein Aggregation: Mechanistic Insights and Future Challenges.
Zheng H, Sun H, Cai Q, Tai HC. · · 2024 · cited 37× · PMID 38732197 · DOI 10.3390/ijms25094969
Disentangling tau: One protein, many therapeutic approaches.
Lane-Donovan C, Boxer AL. · · 2024 · cited 32× · PMID 38278659 · DOI 10.1016/j.neurot.2024.e00321
Symptomatic and Disease-Modifying Therapy Pipeline for Alzheimer's Disease: Towards a Personalized Polypharmacology Patient-Centered Approach.
Morató X, Pytel V, Jofresa S, Ruiz A, et al · · 2022 · cited 32× · PMID 36012569 · DOI 10.3390/ijms23169305
Status of precision medicine approaches to traumatic brain injury.
Reddi S, Thakker-Varia S, Alder J, Giarratana AO. · · 2022 · cited 30× · PMID 35259824 · DOI 10.4103/1673-5374.335824
Tau Immunotherapies for Alzheimer's Disease and Related Tauopathies: Status of Trials and Insights from Preclinical Studies.
Sigurdsson EM. · · 2024 · cited 16× · PMID 38427486 · DOI 10.3233/jad-231238

Verify or expand the search:

Other trials of PNT001

Trials testing the same drug.

NCT04096287 — Safety and Tolerability of PNT001 in Healthy Adults · Phase 1 · completed

Other recruiting trials for Traumatic Brain Injury

Currently open trials in the same condition.

NCT07176936 — Improving Speech in Noise Using Noninvasive Stimulation · NA · recruiting
NCT07473505 — Integrative Bilateral Cervical Sympathetic Blocks for Trauma-Related Symptoms in Special Operations Veterans: A Prospect · recruiting
NCT07455136 — A Study to Develop a Blood-based Test for Aiding the Diagnosis/Prognosis of Traumatic Brain Injury in Adults and for Mon · recruiting
NCT07404761 — Safety and Effectiveness of Spatial StimelMD (SSMD) in Subjects With Upper Limb Neuromotor Impairments · NA · recruiting
NCT07230002 — Effects of Moderate/Severe Traumatic Brain Injury in the Subacute or Chronic Phase on Locomotor Strategies Involved in N · NA · recruiting

Other Pinteon Therapeutics, Inc trials

Trials by the same sponsor.

NCT04096287 — Safety and Tolerability of PNT001 in Healthy Adults · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04677829 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Pinteon Therapeutics, Inc
Last refreshed: 29 June 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04677829.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing