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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03935568
• Other study ID #: PU-AD-01-001
• Status: Terminated
• Phase: Phase 1
• Start date: June 24, 2019
• Est. completion date: December 23, 2019

Study information

• Verified date: April 2023
• Source: Samus Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: December 23, 2019
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• PU-AD
3 cohorts receiving a single oral dose of PU-AD at one time.
• Placebo
3 cohorts receiving a single oral dose of Placebo at one time
• Placebo
2 cohorts receiving multiple oral dose of Placebo at one time
• PU-AD
2 cohorts receiving multiple oral dose of PU-AD at one time

Locations

Country	Name	City	State
United States	ICON Early Phase Services	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Samus Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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