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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/28/2021.

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

Clinicaltrials.gov identifier NCT03935568

Recruitment Status Completed

First Posted May 2, 2019

Last update posted December 26, 2019

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.

  • Condition or Disease:Alzheimer's Disease
  • Intervention/Treatment: Drug: PU-AD
    Drug: Placebo
    Drug: Placebo
    Drug: PU-AD
  • Phase: Phase 1
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 Design
  • Study Type: Interventional
  • Actual Enrollment: 40 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Triple (Participant, Care Provider, Investigator)
  • Primary Purpose: Treatment
  • Official Title: A Single and Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of PU-AD in Healthy Subjects
  • Actual Study Start Date: June 2019
  • Actual Primary Completion Date: December 2019
  • Actual Study Completion Date: December 2019
Arms and interventions
Arm Intervention/treatment
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.
Experimental: Single Dose Placebo
Patients randomized to receive Placebo
Drug: Placebo
3 cohorts receiving a single oral dose of Placebo at one time
Experimental: Multiple Dose (Placebo)
Patients randomized to receive Placebo
Drug: Placebo
2 cohorts receiving multiple oral dose of Placebo at one time
Experimental: Multiple Dose Active (PU-AD)
Patients randomized to receive Active (PU-AD)
Drug: PU-AD
2 cohorts receiving multiple oral dose of PU-AD at one time
Outcome Measures
  • Primary Outcome Measures: 1. To evaluate the safety and tolerability of single and multiple 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 and multiple 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 and multiple 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).
Eligibility Criteria
  • Ages Eligible for Study: 18 to 75 Years (Adult, Older 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 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

Contacts and Locations
Contacts
Locations

United States, Texas
ICON Early Phase Services
San Antonio

Sponsors and Collaborators

Samus Therapeutics, Inc.

Investigators

Study Director: Michael H Silverman, M.D. Samus Therapeutics

More Information
  • 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: December 26, 2019
  • Last Verified: December 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • 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.: Yes
  • Keywords provided by Samus Therapeutics, Inc.: PU-AD
  • Additional relevant MeSH terms: Alzheimer Disease