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.
Age range
18 Years – 45 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Incidence of Dose Limiting Toxicities (DLTs)
Timeframe: Day 1 through 7 days after the last study drug administration
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Timeframe: Day 1 through 7 days after the last study drug administration
Incidence of withdrawals due to Adverse Events (AEs)
Timeframe: Day 1 through 7 days after the last study drug administration
Incidence of abnormal blood work tests results, abnormal Urinalysis and positive Pregnancy test
Timeframe: At baseline, 72 to 96 hours after the last study drug administration, and on Day 7 after the first and the last study drug administration
Change in vital signs
Timeframe: At pre-dose, over 96 hours after study drug administration, and on Day 7 after the last study drug administration
Incidence of abnormal ECG parameters
Timeframe: At pre-dose, over 96 hours after study drug administration, and on Day 7 after the last study drug administration
Incidence of abnormal physical examination findings
Timeframe: At baseline, 96 hours after the last study drug administration, and on Day 7 after the last study drug administration
Maximum observed plasma drug concentration (Cmax)
Timeframe: 0-96 hours
Apparent terminal elimination half-life (t1/2)
Timeframe: 0-96 hours
Time to maximum observed plasma drug concentration (Tmax)
Timeframe: 0-96 hours
Area under the plasma drug concentration-time curve (AUC)
Timeframe: 0-96 hours
Percentage of AUC0-∞ extrapolated from Tlast to infinity (AUCext)
Timeframe: 0-96 hours
Apparent plasma clearance (CL/F)
Timeframe: 0-96 hours
Apparent Volume of distribution (Vz/F)
Timeframe: 0-96 hours