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HealthyPhase 1NCT04096287

Safety and Tolerability of PNT001 in Healthy Adults

A Phase 1 study testing PNT001 in people with Healthy, run by Pinteon Therapeutics, Inc at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This first in human study is a multi-center, randomized, double-blind, placebo-controlled single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of intravenous PNT001 in healthy adult participants. Read more about this study

Who is it for?
Ages 21 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
PNT001
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
49 participants
Where
4 sitesUnited States
Study dates
17 Sep 2019to 15 Feb 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 21 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The participant provides written informed consent.
  • The participant is a male or female (not of childbearing potential), 21 to 65 years of age at time of screening.
  • Female participants must have documented proof that they are not of childbearing potential and must not currently be breastfeeding.
  • Male participants must agree to use barrier contraceptives plus spermicide and refrain from sperm donation during the entire study and for 200 days after dosing has been completed.
  • The participant must not have participated in a clinical drug trial within 3 months of study start, or within 5 half-lives, unless the study blind has been broken and the participant was known to be on placebo
  • The participant must have a body mass index of 18.5 to 30 kg/m^2

Who cannot join

  • Any contraindication or inability to undergo lumbar puncture due to anticoagulant use, platelet level, or coagulation study/INR result
  • Any significant acute or chronic medical illness
  • Any history of cancer within 5 years of enrollment, with the exception of resected skin basal cell carcinoma
  • Any major surgery 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
  • Inability to undergo venipuncture or tolerate venous access
Show all 19Show fewer
  • A history of smoking or using tobacco products within 3 months before study drug administration
  • A history of 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
  • A history or current status of schizophrenia, schizoaffective disorder or bipolar disorder, untreated major depression (DSM-V or ICD-10 criteria)
  • Any significant illness or infection requiring intervention within the prior 30 days as determined by the investigator and sponsor
  • An indication of potential suicidality risk based on the C-SSRS assessment
  • Any of the following abnormalities:
  • serum creatinine > 1.5 mg/dL at screening
  • AST or ALT > 2x the upper limit of normal at screening
  • blood pressure > 140/90 Hg at screening or baseline
  • QTcF > 470 msec at screening or baseline
  • A known hypersensitivity to any components of the PNT001 drug product or placebo (5% dextrose)
  • Current use of or plan to use any medication (prescription or over-the-counter) that would potentially affect the assessment of the pharmacokinetics, pharmacodynamics, or immunogenicity of PNT001

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Hassman Research Institute

    Marlton, New Jersey, 08053

  • Woodland Research Northwest

    Rogers, Arkansas, 72758

  • Worldwide Clinical Trials

    San Antonio, Texas, 78217

  • Pacific Research Network, Inc.

    San Diego, California, 92103

Other trials in United States

About this study

Official title: A Phase 1, Randomized, Double-blind, Placebo-controlled, Single-Ascending-Dose Trial to Evaluate the Safety, Tolerability, Immunogenicity, and Pharmacokinetics of Intravenous PNT001 in Healthy Volunteers

This first in human study is a multi-center, randomized, double-blind, placebo-controlled single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of intravenous PNT001 in healthy adult participants.

Read the detailed description

This Phase 1 clinical trial is a multicenter, double-blind, single ascending dose trial evaluating safety in up to a total of 48 participants across up to 6 dose cohorts, 5 planned and 1 to be determined if an additional dose group is required. Each cohort will include 8 participants (6 active, 2 placebo) who will receive a single dose of either PNT001 or placebo. Within each cohort a sentinel group of 2 participants (1 active, 1 placebo) will be enrolled to evaluate safety and tolerability before enrolling the full cohort. If there are no safety concerns (as determined by the data and safety monitoring board [DSMB]), the remaining 6 participants (randomized as 5 active, 1 placebo) will be enrolled. This process will be followed for all additional cohorts.

After screening, and laboratory assessments at Day -1, eligible participants will be admitted to the research unit on Day 1 (or Day -1 at Investigator's discretion), where they will remain for three (or four) nights with standardized meals provided during their inpatient stay. On Day 1, participants will be randomized to receive either active drug or placebo. Study medication will be administered as a single i.v. infusion over 30 minutes (up to 60 minutes for doses greater than 2,700 mg), followed by collection of safety, tolerability, and PK data over 16 weeks. Participants will be discharged on Day 4 and will return for an outpatient study visit on Day 5 (may be phone or clinic visit), and to the study site on Days 7, 14, 28, 42, 56, 70, 84, 98, and 112.

Conditions
Healthy
Being tested
PNT001, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PNT001Biological

    PNT001 diluted in 5% dextrose

  • PlaceboDrug

    5% dextrose

Study groups in NCT04096287
Study groupRoleWhat they receive
PNT001ExperimentalSingle escalating doses of intravenous PNT001 administered as a 30 minute infusion at doses of 33mg, 100mg, 300mg, 900mg, 2700mg, and as a 60 minute infusion at 4000 mg
Receives: Biological: PNT001
PlaceboPlacebo comparatorSingle intravenous dose of vehicle administered as a 30 minute infusion up to 2700 mg and as a 60 minute infusion at 4000 mg
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment Emergent Adverse Events

    assess adverse events during 16 week duration of study

    Measured: 16 weeks

  2. Incidence of Treatment Emergent Clinical Laboratory Test Abnormalities

    measure clinical laboratory values during 16 week duration of study

    Measured: 16 weeks

  3. Incidence of Treatment Emergent Abnormalities in Physical Examination Findings

    observe skin, eyes, ears, nose, throat, cardiac and pulmonary status, abdomen, and extremities for any abnormalities

    Measured: 16 weeks

  4. Incidence of Treatment Emergent Abnormalities in Neurological Examination Findings

    perform a neurological assessment of orientation, cranial nerve function, limb function for presence of involuntary movements, muscle mass, tone, and strength, coordination, reflexes, sensation, joint position, gait, Romberg test

    Measured: 16 weeks

  5. Incidence of Treatment Emergent Abnormalities in Blood Pressure

    measure resting pulse rate as beats per minute

    Measured: 16 weeks

  6. Incidence of Treatment Emergent Abnormalities in Pulse Rate

    measure systolic and diastolic blood pressure in mmHg

    Measured: 16 weeks

  7. Incidence of Treatment Emergent Abnormalities in 12 lead Electrocardiogram Assessment

    measure QT and calculate QTcF value

    Measured: 16 weeks

Secondary outcomes (2)

  1. Pharmacokinetic properties of PNT001 in Serum

    measure concentration of PNT001 in serum

    Measured: 16 weeks

  2. Pharmacokinetic properties of PNT001 in Cerebrospinal Fluid (CSF)

    measure concentration of PNT001 in CSF

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2019
  2. Study start17 Sep 2019
  3. Primary completion15 Feb 2021
  4. Study completion15 Feb 2021

Resources

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04096287
Sponsor's protocol ID
PNT001-001
Status last verified
Feb 2021
First submitted
17 Sep 2019
Last updated
23 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Luca W, Foster K, McClure K, Ahlijanian MK, Jefson M. A Phase 1 Single-Ascending-Dose Trial in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravenous PNT001, a Novel Mid-domain Tau Antibody Targeting cis-pT231 Tau. J Prev Alzheimers Dis. 2024;11(2):366-374. doi: 10.14283/jpad.2024.25.

    PubMed 38374743

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PNT001 in people with Healthy, run by Pinteon Therapeutics, Inc at 4 sites 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 6 inclusion and 19 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: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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: 16 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04096287, which also lists 1 linked publication.

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 23 Feb 2021.

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