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

Phase 1

Terminated

• Conditions: Alzheimer's Disease
• Interventions: Drug: Placebo; Drug: PU-AD

• Registration Number: NCT03935568
• Lead Sponsor: Samus Therapeutics, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-04-30
• Study First Posted: 2019-05-02
• Study Start: 2019-06-24
• Primary Completion: 2019-12-23
• Study Completion: 2019-12-23
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-13
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple Dose (Placebo)	Placebo	Patients randomized to receive Placebo
Single Dose Placebo	Placebo	Patients randomized to receive Placebo
Single Dose Active (PU-AD)	PU-AD	Patients randomized to receive Active (PU-AD)
Multiple Dose Active (PU-AD)	PU-AD	Patients randomized to receive Active (PU-AD)

Primary Outcome Measures

Name	Time	Method
To evaluate the safety and tolerability of single and multiple doses of PU-AD in healthy subjects	Day 1 to Day 3	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.

Secondary Outcome Measures

Name	Time	Method
To determine the pharmacokinetics (PK) PU-AD in healthy subjects	Day 1 to Day 3	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).

Trial Locations

Locations (1)

ICON Early Phase Services; 🇺🇸 San Antonio, Texas, United States