Traumatic Brain InjuryPhase 1NCT04677829
Safety and Tolerability of PNT001 in Patients With Acute Traumatic Brain Injury (TBI)
A Phase 1 study testing PNT001 and %5 dextrose for infusion in people with Traumatic Brain Injury, run by Pinteon Therapeutics, Inc at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- PNT001 and %5 dextrose for infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2021to 12 Apr 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Phase 1, 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 (TBI)
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.
Read the 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 be randomized to receive three doses of either PNT001 or placebo. Doses studied will be 1000mg and 4000mg.
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 24 hours after initial dose. Baseline biomarker collection and cognitive assessments will be completed. Study medication will be administered as an IV infusion over 30 minutes (for 1000mg cohort) or 60 minutes (for 4000mg cohort) followed by collection of safety, tolerability, pharmacokinetic, biomarker, imaging, and cognitive data over 12 weeks. Subsequent dosing visits will be at Days 28 and 56. All visits after initial discharge will be on an outpatient basis.
- Conditions
- Traumatic Brain Injury
- Being tested
- PNT001, %5 dextrose for infusion
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNT001Biological
30 minute infusion for PNT001 1000mg; 60 minute infusion for PNT001 4000mg
%5 dextrose for infusionBiological
30 min placebo infusion for 1000mg; 60 minute placebo infusion for 4000mg
| Study group | Role | What they receive |
|---|---|---|
| PNT001 1000mg | Experimental | PNT001 diluted in 5% dextrose for infusion Receives: Biological: PNT001 |
| PNT001 4000mg | Experimental | PNT001 diluted in 5% dextrose for infusion Receives: Biological: %5 dextrose for infusion |
| Placebo | Placebo comparator | 5% dextrose for infusion Receives: Biological: PNT001; Biological: %5 dextrose for infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment Emergent Adverse Events
assess adverse events
Measured: 84 day study duration
Incidence of Treatment Emergent Clinical Laboratory Test Abnormalities
measure clinical laboratory values
Measured: 84 day study duration
Incidence of Treatment Emergent Abnormalities in Physical Examination Findings
perform physical examination
Measured: 84 day study duration
Incidence of Treatment Emergent Abnormalities in Neurological Examination Findings
perform neurological examination
Measured: 84 day study duration
Incidence of Treatment Emergent Abnormalities in Vital Signs
assess blood pressure, pulse, temperature, respiratory rate
Measured: 84 day study duration
Incidence of Treatment Emergent Abnormalities in 12-lead Electrocardiogram Assessment
measure ECG parameters
Measured: 84 day duration of study
Secondary outcomes (1)
Pharmacokinetic Properties of PNT001 in Serum
measure concentration of PNT001 in serum
Measured: 84 day duration of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2020
- Study start29 Mar 2021
- Primary completion12 Apr 2021
- Study completion12 Apr 2021
Why it stopped: The study was terminated due to administrative, non-safety related reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Escalating dose level cohorts; each cohort with an active and a placebo arm
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pinteon Therapeutics, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Larry Altstiel, MD, PhD, Study director, Pinteon Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04677829
- Sponsor's protocol ID
- PNT001-002
- Status last verified
- Jun 2022
- First submitted
- 6 Dec 2020
- Last updated
- 29 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1, 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 (TBI)
- ClinicalTrials.gov ID
- NCT04677829
- Acronym / sponsor ID
- PNT001-002
- Conditions
- Traumatic Brain Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to administrative, non-safety related reasons.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Pinteon Therapeutics, IncIndustry (pharma, biotech, devices)
- Collaborators
- United States Department of Defense
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 12 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 21 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 be randomized to receive three doses of either PNT001 or placebo. Doses studied will be 1000mg and 4000mg.
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 24 hours after initial dose. Baseline biomarker collection and cognitive assessments will be completed. Study medication will be administered as an IV infusion over 30 minutes (for 1000mg cohort) or 60 minutes (for 4000mg cohort) followed by collection of safety, tolerability, pharmacokinetic, biomarker, imaging, and cognitive data over 12 weeks. Subsequent dosing visits will be at Days 28 and 56. All visits after initial discharge will be on an outpatient basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Escalating dose level cohorts; each cohort with an active and a placebo arm
| Arm | Type | Receives |
|---|---|---|
| PNT001 1000mg | Experimental | Biological: PNT001PNT001 diluted in 5% dextrose for infusion |
| PNT001 4000mg | Experimental | Biological: %5 dextrose for infusionPNT001 diluted in 5% dextrose for infusion |
| Placebo | Placebo comparator | Biological: PNT001, Biological: %5 dextrose for infusion5% dextrose for infusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNT00130 minute infusion for PNT001 1000mg; 60 minute infusion for PNT001 4000mg | Biological | PNT001 1000mg, Placebo |
| %5 dextrose for infusion30 min placebo infusion for 1000mg; 60 minute placebo infusion for 4000mg | Biological | PNT001 4000mg, Placebo |
Primary outcome
Incidence of Treatment Emergent Adverse Events
Time frame: 84 day study duration
assess adverse events
Incidence of Treatment Emergent Clinical Laboratory Test Abnormalities
Time frame: 84 day study duration
measure clinical laboratory values
Incidence of Treatment Emergent Abnormalities in Physical Examination Findings
Time frame: 84 day study duration
perform physical examination
Incidence of Treatment Emergent Abnormalities in Neurological Examination Findings
Time frame: 84 day study duration
perform neurological examination
Incidence of Treatment Emergent Abnormalities in Vital Signs
Time frame: 84 day study duration
assess blood pressure, pulse, temperature, respiratory rate
Incidence of Treatment Emergent Abnormalities in 12-lead Electrocardiogram Assessment
Time frame: 84 day duration of study
measure ECG parameters
1 secondary outcome
Pharmacokinetic Properties of PNT001 in Serum
Time frame: 84 day duration of study
Results and safety
The study was stopped early (reason given: The study was terminated due to administrative, non-safety related reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Larry Altstiel, MD, PhD study director
Pinteon Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PNT001 and %5 dextrose for infusion in people with Traumatic Brain Injury, run by Pinteon Therapeutics, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was terminated due to administrative, non-safety related reasons.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment Emergent Adverse Events (time frame: 84 day study duration). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2022.