A Phase 1 interventional study of PU-AD and Placebo in Alzheimer's Disease, sponsored by Samus Therapeutics, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-18.
Sponsored by Samus Therapeutics, Inc. · Phase 1, Interventional, and Treatment
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 40 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Samus Therapeutics, Inc. is the lead sponsor of 8 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients randomized to receive Placebo
Drug: Placebo
Patients randomized to receive Active (PU-AD)
Drug: PU-AD
Patients randomized to receive Placebo
Drug: Placebo
Patients randomized to receive Active (PU-AD)
Drug: PU-AD
3 cohorts receiving a single oral dose of PU-AD at one time.
3 cohorts receiving a single oral dose of Placebo at one time
2 cohorts receiving multiple oral dose of Placebo at one time
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
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
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.
Time frame: 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.
Time frame: 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. (Maximum observed concentration (Cmax).
Time frame: 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. (Time to maximum observed concentration (tmax).
Time frame: 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).
Time frame: Day 1 to Day 3
Plan to share: No
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This study is terminated, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Samus Therapeutics, Inc.