Study Stopped
Company ceased operations
A Single and Multiple Ascending Dose Study to Evaluate the Safety and Pharmacokinetics of PU-AD in Healthy Subjects
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2019
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2019
CompletedFirst Posted
Study publicly available on registry
May 2, 2019
CompletedStudy Start
First participant enrolled
June 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2019
CompletedApril 18, 2023
April 1, 2023
6 months
April 24, 2019
April 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (3)
To determine the pharmacokinetics (PK) PU-AD in healthy subjects
Day 1 to Day 3
To determine the pharmacokinetics (PK) PU-AD in healthy subjects
Day 1 to Day 3
To determine the pharmacokinetics (PK) PU-AD in healthy subjects
Day 1 to Day 3
Study Arms (4)
Single Dose Placebo
EXPERIMENTALPatients randomized to receive Placebo
Single Dose Active (PU-AD)
EXPERIMENTALPatients randomized to receive Active (PU-AD)
Multiple Dose (Placebo)
EXPERIMENTALPatients randomized to receive Placebo
Multiple Dose Active (PU-AD)
EXPERIMENTALPatients randomized to receive Active (PU-AD)
Interventions
Eligibility Criteria
You may qualify if:
- Male or female (Women of non-child bearing potential)
- to 60 years of age for part one, \>/= 60 years of age for part two
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ICON Early Phase Services
San Antonio, Texas, 78209, United States
Related Publications (1)
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.
PMID: 36281667DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael H Silverman, M.D.
Samus Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2019
First Posted
May 2, 2019
Study Start
June 24, 2019
Primary Completion
December 23, 2019
Study Completion
December 23, 2019
Last Updated
April 18, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share