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

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ClinicalTrials.gov Identifier: NCT03935568
Recruitment Status : Recruiting
First Posted : May 2, 2019
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Samus Therapeutics, Inc.

Brief Summary:
This is a first in human Phase 1 study in healthy volunteers receiving a single dose of PU AD in three small cohorts.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: PU-AD Drug: Placebo Phase 1

Detailed Description:
This is a Phase 1, double-blind trial. A single ascending dose study in approximately 3 cohorts receiving a single oral dose of PU-AD or placebo. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Single Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of PU-AD in Healthy Subjects
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Single Dose Placebo
Patients randomized to receive Placebo
Drug: Placebo
3 cohorts receiving a single oral dose of Placebo at one time

Experimental: Single Dose Active (PU-AD)
Patients randomized to receive Active (PU-AD)
Drug: PU-AD
3 cohorts receiving a single oral dose of PU-AD at one time.




Primary Outcome Measures :
  1. To evaluate the safety and tolerability of single doses of PU-AD in healthy subjects [ Time Frame: Day 1 to Day 3 ]
    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.

  2. To evaluate the safety and tolerability of single doses of PU-AD in healthy subjects [ Time Frame: Day 1 to Day 3 ]
    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.

  3. To evaluate the safety and tolerability of single doses of PU-AD in healthy subjects [ Time Frame: 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 :
  1. To determine the pharmacokinetics (PK) PU-AD in healthy subjects [ Time Frame: 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. (Maximum observed concentration (Cmax).

  2. To determine the pharmacokinetics (PK) PU-AD in healthy subjects [ Time Frame: 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. (Time to maximum observed concentration (tmax).

  3. To determine the pharmacokinetics (PK) PU-AD in healthy subjects [ Time Frame: 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).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female (Women of non-child bearing potential)
  2. 18 to 60 years of age

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03935568


Contacts
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Contact: Beverlee Loeser 646-902-9271 loeserb@samustherapeutics.com

Locations
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United States, Texas
ICON Early Phase Services Recruiting
San Antonio, Texas, United States, 78209
Contact: Cassandra Key, MD    210-283-4500      
Sponsors and Collaborators
Samus Therapeutics, Inc.
Investigators
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Study Director: Hagop Youssoufian, M.D. Samus Therapeutics

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Responsible Party: Samus Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03935568     History of Changes
Other Study ID Numbers: PU-AD-01-001
First Posted: May 2, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by Samus Therapeutics, Inc.:
PU-AD

Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders