Safety and Tolerability of PNT001 in Healthy Adults

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT04096287

Run by

Pinteon Therapeutics, Inc

People needed

49

Starts

2019-09-17

Expected to finish

2021-02-15

Last updated by the study team

2021-02-23

Who can join

Age: 21 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Woodland Research Northwest — Rogers, Arkansas, United States
• Pacific Research Network, Inc. — San Diego, California, United States
• Hassman Research Institute — Marlton, New Jersey, United States
• Worldwide Clinical Trials — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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