Safety and Tolerability of PNT001 in Healthy Adults

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