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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-24

Study Completion Date

2019-12-23

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.

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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.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Single Dose Placebo

Patients randomized to receive Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

3 cohorts receiving a single oral dose of Placebo at one time

Single Dose Active (PU-AD)

Patients randomized to receive Active (PU-AD)

Group Type EXPERIMENTAL

PU-AD

Intervention Type DRUG

3 cohorts receiving a single oral dose of PU-AD at one time.

Multiple Dose (Placebo)

Patients randomized to receive Placebo

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

2 cohorts receiving multiple oral dose of Placebo at one time

Multiple Dose Active (PU-AD)

Patients randomized to receive Active (PU-AD)

Group Type EXPERIMENTAL

PU-AD

Intervention Type DRUG

2 cohorts receiving multiple oral dose of PU-AD at one time

Interventions

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PU-AD

3 cohorts receiving a single oral dose of PU-AD at one time.

Intervention Type DRUG

Placebo

3 cohorts receiving a single oral dose of Placebo at one time

Intervention Type DRUG

Placebo

2 cohorts receiving multiple oral dose of Placebo at one time

Intervention Type DRUG

PU-AD

2 cohorts receiving multiple oral dose of PU-AD at one time

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female (Women of non-child bearing potential)
2. 18 to 60 years of age for part one, \>/= 60 years of age for part two

Exclusion Criteria

1. Women of child bearing potential or Female with positive pregnancy test or who is lactating.
2. 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.
3. History or presence of conditions that may place the subject at increased risk as determined by the PI.
4. Has taken other investigational drugs or participated in any clinical study within 30 days.
5. 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes