drugset / Trial / NCT04512963

Phase I Study of Progerinin in Healthy Volunteers

NCT04512963

RandomizedSequentialQuadruple-blindTreatment

Summary

PRG-PRO-001 is a Phase I, Randomized, Double-blind, Placebo-Controlled, Single Ascending Dose (SAD) Study including a food interaction study, followed by a Multiple Ascending Dose (MAD) Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Profile of Progerinin in Healthy Volunteers. This is a first-in-human study. The study aims to determine the safety and tolerability of Progerinin after single and multiple doses in healthy volunteers and to evaluate the pharmacokinetics (PK) of Progerinin after single and multiple dose administrations in healthy volunteers.

Timeline

Start
2020-08-24
Primary completion
2021-07-27
Completion
2021-07-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Progerinin Small molecule Oral