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NCT04512963 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Progerinin in Healthy Volunteers
A Phase 1 study of Hutchinson-Gilford Progeria Syndrome and Werner Syndrome, sponsored by PRG Science & Technology Co..
- Completed
- Registry status
- Phase 1
- Development phase
- 64
- Enrollment target
- 1
- Study location
NCT04512963: Completed Phase 1 study of Hutchinson-Gilford Progeria Syndrome and Werner Syndrome, sponsored by PRG Science & Technology Co..
NCT04512963 is a Phase 1 study of Hutchinson-Gilford Progeria Syndrome and Werner Syndrome that has completed, run by PRG Science & Technology Co.. The registered enrollment target is 64 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04512963, a Phase 1 study of Hutchinson-Gilford Progeria Syndrome and Werner Syndrome, has completed, sponsored by PRG Science & Technology Co..
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 64 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Any clinically significant adverse event (AE)/serious adverse event (SAE) or clinically significant laboratory abnormality which is classified as \> Grade 2 (according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0), where applicable, deemed by the investigator as at least "possibly, probably or definitely related" to Progerinin but unrelated to concurrent illness, or concomitant medications.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Progerinin
Study Locations (1)
California
- PRG S&T Investigational Site - Glendale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 64 participants |
| Start Date | 2020-08-24 |
| Est. Completion | 2021-07-27 |
| Phase | Phase 1 |
What the finished NCT04512963 record still lists
NCT04512963 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 64 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 2 conditions, with Hutchinson-Gilford Progeria Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04512963 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT04512963 about?
NCT04512963 is a clinical study titled "Phase I Study of Progerinin in Healthy Volunteers". 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 ...
What is the current status of trial NCT04512963?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 64 participants. The study started on 2020-08-24. Estimated completion is 2021-07-27.
What conditions does trial NCT04512963 study?
This clinical trial studies the following conditions: Hutchinson-Gilford Progeria Syndrome, Werner Syndrome.
What interventions are being tested in trial NCT04512963?
The interventions under investigation include: Placebo (DRUG), Progerinin (DRUG).
Who is sponsoring clinical trial NCT04512963?
This trial is sponsored by PRG Science & Technology Co., which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04512963 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04512963's enrollment target sits among peer trials
64 808th of 2000 higher than 1,181 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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