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

Samus Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: Placebo; Drug: PU-AD

Study type: Interventional

Funder types: Industry

Identifiers

NCT03935568

PU-AD-01-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 4 patient groups

Single Dose Placebo

Experimental group

Description:

Patients randomized to receive Placebo

Treatment:

Drug: Placebo

Drug: Placebo

Single Dose Active (PU-AD)

Experimental group

Description:

Patients randomized to receive Active (PU-AD)

Treatment:

Drug: PU-AD

Drug: PU-AD

Multiple Dose (Placebo)

Experimental group

Description:

Patients randomized to receive Placebo

Treatment:

Drug: Placebo

Drug: Placebo

Multiple Dose Active (PU-AD)

Experimental group

Description:

Patients randomized to receive Active (PU-AD)

Treatment:

Drug: PU-AD

Drug: PU-AD