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

Phase 1 Terminated 40 enrolled Samus Therapeutics, Inc.

RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start: 2019-06-24
Primary completion: 2019-12-23
Completion: 2019-12-23

Outcome

Outcome not reported

Stopped: “Company ceased operations”

Publications

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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Icapamespib	Small molecule	10 mg	Oral
Subject	Icapamespib	Small molecule	20 mg	Oral
Subject	Icapamespib	Small molecule	30 mg	Oral