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Safety and Tolerability of PNT001 in Healthy Adults

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ClinicalTrials.gov Identifier: NCT04096287
Recruitment Status : Recruiting
First Posted : September 19, 2019
Last Update Posted : December 4, 2019
Sponsor:
Information provided by (Responsible Party):
Pinteon Therapeutics, Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy Biological: PNT001 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : September 17, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Experimental: PNT001
Single escalating doses of intravenous PNT001 administered as a 30 minute infusion at doses of 33mg, 100mg, 300mg, 900mg, 2700mg
Biological: PNT001
PNT001 diluted in 5% dextrose

Placebo Comparator: Placebo
Single intravenous dose of vehicle administered as a 30 minute infusion
Drug: Placebo
5% dextrose




Primary Outcome Measures :
  1. Incidence of Treatment Emergent Adverse Events [ Time Frame: 16 weeks ]
    assess adverse events during 16 week duration of study

  2. Incidence of Treatment Emergent Clinical Laboratory Test Abnormalities [ Time Frame: 16 weeks ]
    measure clinical laboratory values during 16 week duration of study

  3. Incidence of Treatment Emergent Abnormalities in Physical Examination Findings [ Time Frame: 16 weeks ]
    observe skin, eyes, ears, nose, throat, cardiac and pulmonary status, abdomen, and extremities for any abnormalities

  4. Incidence of Treatment Emergent Abnormalities in Neurological Examination Findings [ Time Frame: 16 weeks ]
    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

  5. Incidence of Treatment Emergent Abnormalities in Blood Pressure [ Time Frame: 16 weeks ]
    measure resting pulse rate as beats per minute

  6. Incidence of Treatment Emergent Abnormalities in Pulse Rate [ Time Frame: 16 weeks ]
    measure systolic and diastolic blood pressure in mmHg

  7. Incidence of Treatment Emergent Abnormalities in 12 lead Electrocardiogram Assessment [ Time Frame: 16 weeks ]
    measure QT and calculate QTcF value


Secondary Outcome Measures :
  1. Pharmacokinetic properties of PNT001 in Serum [ Time Frame: 16 weeks ]
    measure concentration of PNT001 in serum

  2. Pharmacokinetic properties of PNT001 in Cerebrospinal Fluid (CSF) [ Time Frame: 28 days ]
    measure concentration of PNT001 in CSF


Other Outcome Measures:
  1. Pharmacodynamic effects of PNT001 in Cerebrospinal Fluid - total tau [ Time Frame: 28 days ]
    measure CSF concentrations of total tau

  2. Pharmacodynamic effects of PNT001 in Cerebrospinal Fluid - cis-pT231 tau [ Time Frame: 28 days ]
    measure CSF concentrations of cis-pT231 tau

  3. Pharmacodynamic effects of PNT001 in Cerebrospinal Fluid - total pT231 tau [ Time Frame: 28 days ]
    measure CSF concentrations of total pT231 tau

  4. Pharmacodynamic effects of PNT001 in Cerebrospinal Fluid - NfL [ Time Frame: 28 days ]
    measure CSF concentrations of Neurofilament Light Chain (NfL)

  5. Pharmacodynamic effects of PNT001 in Serum - NfL [ Time Frame: 28 days ]
    measure serum concentrations of Neurofilament Light Chain (NfL)

  6. Immunogenicity of PNT001 - ADA [ Time Frame: 16 weeks ]
    measure presence of antidrug antibodies (ADA) in serum



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096287


Contacts
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Contact: Wendy J Luca 860-319-9938 wluca@pinteon.com

Locations
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United States, Arkansas
Woodland Research Northwest Recruiting
Rogers, Arkansas, United States, 72758
Contact: Petra Stark    479-927-3000    pstark@ergclinical.com   
United States, California
Pacific Research Network, Inc. Recruiting
San Diego, California, United States, 92103
Contact: Dixie Creager    619-294-4302    dcreager@ergclinical.com   
United States, New Jersey
Hassman Research Institute Recruiting
Marlton, New Jersey, United States, 08053
Contact: Lisa Wilkins    856-753-7335    lwilkins@hritrials.com   
United States, Texas
Worldwide Clinical Trials Recruiting
San Antonio, Texas, United States, 78217
Contact: Debbie Miksch    512-615-2285    debbie.miksch@worldwide.com   
Sponsors and Collaborators
Pinteon Therapeutics, Inc
Investigators
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Study Director: Larry D. Altstiel, MD, PhD Pinteon Therapeutics, Inc
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Responsible Party: Pinteon Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT04096287    
Other Study ID Numbers: PNT001-001
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No