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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Dose Placebo | Experimental | Patients randomized to receive Placebo |
|
| Single Dose Active (PU-AD) | Experimental | Patients randomized to receive Active (PU-AD) |
|
| Multiple Dose (Placebo) | Experimental | Patients randomized to receive Placebo |
|
| Multiple Dose Active (PU-AD) | Experimental | Patients randomized to receive Active (PU-AD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PU-AD | Drug | 3 cohorts receiving a single oral dose of PU-AD at one time. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| To determine the pharmacokinetics (PK) PU-AD in healthy subjects |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael H Silverman, M.D. | Samus Therapeutics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON Early Phase Services | San Antonio | Texas | 78209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36281667 | Derived | Silverman MH, Duggan S, Bardelli G, Sadler B, Key C, Medlock M, Reynolds L, Wallner B. Safety, Tolerability and Pharmacokinetics of Icapamespib, a Selective Epichaperome Inhibitor, in Healthy Adults. J Prev Alzheimers Dis. 2022;9(4):635-645. doi: 10.14283/jpad.2022.71. |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Placebo |
| Drug |
3 cohorts receiving a single oral dose of Placebo at one time |
|
| Placebo | Drug | 2 cohorts receiving multiple oral dose of Placebo at one time |
|
| PU-AD | Drug | 2 cohorts receiving multiple oral dose of PU-AD at one time |
|
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 |
| 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 |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |