NCT03935568

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Samus Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

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

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	PU-AD	3 cohorts receiving a single oral dose of PU-AD at one time.
DRUG	Placebo	3 cohorts receiving a single oral dose of Placebo at one time
DRUG	Placebo	2 cohorts receiving multiple oral dose of Placebo at one time
DRUG	PU-AD	2 cohorts receiving multiple oral dose of PU-AD at one time

Timeline

• Start date: 2019-06-24
• Primary completion: 2019-12-23
• Completion: 2019-12-23
• First posted: 2019-05-02
• Last updated: 2023-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study