A Single and Multiple 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 :
Completed
First Posted : May 2, 2019
Last Update Posted : December 26, 2019
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Condition or disease | Intervention/treatment | Phase |
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Alzheimer's Disease | Drug: PU-AD Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
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 24, 2019 |
Actual Primary Completion Date : | December 23, 2019 |
Actual Study Completion Date : | December 23, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Single Dose Placebo
Patients randomized to receive Placebo
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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)
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Drug: PU-AD
3 cohorts receiving a single oral dose of PU-AD at one time. |
Experimental: Multiple Dose (Placebo)
Patients randomized to receive Placebo
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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)
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Drug: PU-AD
2 cohorts receiving multiple oral dose of PU-AD at one time |
- 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.
- 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.
- 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.
- 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).
- 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).
- 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 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

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
United States, Texas | |
ICON Early Phase Services | |
San Antonio, Texas, United States, 78209 |
Study Director: | Michael H Silverman, M.D. | Samus Therapeutics |
Responsible Party: | Samus Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT03935568 |
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.: | No |
PU-AD |
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |