A Single and Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of PU-AD in Healthy Subjects

Study Overview
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Brief Summary
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This is a first in human Phase 1 study in two parts with healthy volunteers receiving a single dose of PU AD in three small cohorts and a multiple ascending dose in two small cohorts.

Detailed Description
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This is a Phase 1, double-blind trial in two parts. A single ascending dose study in approximately 3 cohorts receiving a single oral dose of PU-AD or placebo and a multiple ascending dose study in 2 cohorts. Each subject in all cohorts will be administered an oral solution of PU AD or placebo under fasting conditions. Each cohort will contain subjects randomized to active treatment or placebo, evaluating safety and tolerance.

Official Title
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A Single and Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of PU-AD in Healthy Subjects

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: PU-AD
* Drug: Placebo
* Drug: Placebo
* Drug: PU-AD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female (Women of non-child bearing potential) 18 to 60 years of age for part one, >/= 60 years of age for part two Exclusion Criteria: Women of child bearing potential or Female with positive pregnancy test or who is lactating. History or presence of conditions, which in the judgment of the PI, are known to interfere with the absorption distribution, metabolism, or excretion of drugs. History or presence of conditions that may place the subject at increased risk as determined by the PI. Has taken other investigational drugs or participated in any clinical study within 30 days. Any other condition or prior therapy that, in the PI's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Dose Placebo<br>Patients randomized to receive Placebo | Drug: Placebo<br>* 3 cohorts receiving a single oral dose of Placebo at one time<br>|
| Experimental: Single Dose Active (PU-AD)<br>Patients randomized to receive Active (PU-AD) | Drug: PU-AD<br>* 3 cohorts receiving a single oral dose of PU-AD at one time.<br>|
| Experimental: Multiple Dose (Placebo)<br>Patients randomized to receive Placebo | Drug: Placebo<br>* 2 cohorts receiving multiple oral dose of Placebo at one time<br>|
| Experimental: Multiple Dose Active (PU-AD)<br>Patients randomized to receive Active (PU-AD) | Drug: PU-AD<br>* 2 cohorts receiving multiple oral dose of PU-AD at one time<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of single and multiple doses of PU-AD in healthy subjects | Adverse Event (AE) incidence and changes from baseline in clinical laboratory test results. Number and percentage of subjects reporting any treatment emergent AE will be tabulated by system organ class and preferred term for each treatment (coded using Medical Dictionary for Regulatory Activities). Treatment-emergent AEs will be further classified by severity and relationship to treatment. | Day 1 to Day 3 | 
| To evaluate the safety and tolerability of single and multiple doses of PU-AD in healthy subjects | Adverse event incidence and changes from baseline in Electrocardiogram. Number and percentage of subjects reporting any treatment emergent AE will be tabulated by system organ class and preferred term for each treatment (coded using Medical Dictionary for Regulatory Activities). Treatment-emergent AEs will be further classified by severity and relationship to treatment. | Day 1 to Day 3 | 
| To evaluate the safety and tolerability of single and multiple doses of PU-AD in healthy subjects | Adverse event incidence and changes from baseline in vital signs . Number and percentage of subjects reporting any treatment emergent AE will be tabulated by system organ class and preferred term for each treatment (coded using Medical Dictionary for Regulatory Activities). Treatment-emergent AEs will be further classified by severity and relationship to treatment. | Day 1 to Day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the pharmacokinetics (PK) PU-AD in healthy subjects | Collect PK parameters to estimate human exposure,after dose administration for each cohort will be evaluated using a power model for dose proportionality. (Maximum observed concentration (Cmax). | Day 1 to Day 3 | 
| To determine the pharmacokinetics (PK) PU-AD in healthy subjects | Collect PK parameters to estimate human exposure,after dose administration for each cohort will be evaluated using a power model for dose proportionality. (Time to maximum observed concentration (tmax). | Day 1 to Day 3 | 
| To determine the pharmacokinetics (PK) PU-AD in healthy subjects | Collect PK parameters to estimate human exposure,after dose administration for each cohort will be evaluated using a power model for dose proportionality. (Area under the concentration-time curve (AUC). | Day 1 to Day 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PU-AD