Back to resultsA Single and Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of PU-AD in Healthy Subjects
Primary Purpose
Alzheimer's Disease
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PU-AD
Placebo
Placebo
PU-AD
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease focused on measuring PU-AD
Eligibility Criteria
Inclusion Criteria:
- Male or female (Women of non-child bearing potential)
- 18 to 60 years of age for part one, >/= 60 years of age for part two
Exclusion Criteria:
- Women of child bearing potential or Female with positive pregnancy test or who is lactating.
- 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.
- History or presence of conditions that may place the subject at increased risk as determined by the PI.
- Has taken other investigational drugs or participated in any clinical study within 30 days.
- 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
Sites / Locations
- ICON Early Phase Services
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Single Dose Placebo
Single Dose Active (PU-AD)
Multiple Dose (Placebo)
Multiple Dose Active (PU-AD)
Arm Description
Patients randomized to receive Placebo
Patients randomized to receive Active (PU-AD)
Patients randomized to receive Placebo
Patients randomized to receive Active (PU-AD)
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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).
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).
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).
Full Information
NCT ID
NCT03935568
First Posted
April 24, 2019
Last Updated
April 13, 2023
Sponsor
Samus Therapeutics, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03935568
Brief Title
A Single and Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of PU-AD in Healthy Subjects
Official Title
A Single and Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of PU-AD in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Terminated
Why Stopped
Company ceased operations
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
December 23, 2019 (Actual)
Study Completion Date
December 23, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samus Therapeutics, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
PU-AD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Dose Placebo
Arm Type
Experimental
Arm Description
Patients randomized to receive Placebo
Arm Title
Single Dose Active (PU-AD)
Arm Type
Experimental
Arm Description
Patients randomized to receive Active (PU-AD)
Arm Title
Multiple Dose (Placebo)
Arm Type
Experimental
Arm Description
Patients randomized to receive Placebo
Arm Title
Multiple Dose Active (PU-AD)
Arm Type
Experimental
Arm Description
Patients randomized to receive Active (PU-AD)
Intervention Type
Drug
Intervention Name(s)
PU-AD
Intervention Description
3 cohorts receiving a single oral dose of PU-AD at one time.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
3 cohorts receiving a single oral dose of Placebo at one time
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 cohorts receiving multiple oral dose of Placebo at one time
Intervention Type
Drug
Intervention Name(s)
PU-AD
Intervention Description
2 cohorts receiving multiple oral dose of PU-AD at one time
Primary Outcome Measure Information:
Title
To evaluate the safety and tolerability of single and multiple doses of PU-AD in healthy subjects
Description
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.
Time Frame
Day 1 to Day 3
Title
To evaluate the safety and tolerability of single and multiple doses of PU-AD in healthy subjects
Description
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.
Time Frame
Day 1 to Day 3
Title
To evaluate the safety and tolerability of single and multiple doses of PU-AD in healthy subjects
Description
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.
Time Frame
Day 1 to Day 3
Secondary Outcome Measure Information:
Title
To determine the pharmacokinetics (PK) PU-AD in healthy subjects
Description
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).
Time Frame
Day 1 to Day 3
Title
To determine the pharmacokinetics (PK) PU-AD in healthy subjects
Description
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).
Time Frame
Day 1 to Day 3
Title
To determine the pharmacokinetics (PK) PU-AD in healthy subjects
Description
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).
Time Frame
Day 1 to Day 3
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female (Women of non-child bearing potential)
18 to 60 years of age for part one, >/= 60 years of age for part two
Exclusion Criteria:
Women of child bearing potential or Female with positive pregnancy test or who is lactating.
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.
History or presence of conditions that may place the subject at increased risk as determined by the PI.
Has taken other investigational drugs or participated in any clinical study within 30 days.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael H Silverman, M.D.
Organizational Affiliation
Samus Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
ICON Early Phase Services
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Single and Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of PU-AD in Healthy Subjects
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