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NCT05429073 · ClinicalTrials.gov registry record · Phase 1
A Study of RGLS8429 in Healthy Volunteers
A Phase 1 study of Healthy Volunteers, sponsored by Regulus Therapeutics.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
- 1
- Study location
NCT05429073: Completed Phase 1 study of Healthy Volunteers, sponsored by Regulus Therapeutics.
NCT05429073 is a Phase 1 study of Healthy Volunteers that has completed, run by Regulus Therapeutics. The registered enrollment target is 32 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05429073, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Regulus Therapeutics.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
- 1
- Study location
Study Summary
Primary Objective • To assess the safety and tolerability of single ascending doses of RGLS8429 Secondary Objectives * To identify dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) of a single SC dose of RGLS8429 * To characterize the pharmacokinetic (PK) properties of RGLS8429
Primary Outcome
Incidence and severity of adverse events after administration of RGLS8429
Conditions Studied
Interventions
- DRUG RGLS8429
- DRUG Placebo volume-matching RGLS8429 dose
Study Locations (1)
Texas
- ICON Early Phase Services - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2022-06-10 |
| Est. Completion | 2022-09-08 |
| Phase | Phase 1 |
What the finished NCT05429073 record still lists
NCT05429073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which RGLS8429 is the first listed.
NCT05429073 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT05429073 about?
NCT05429073 is a clinical study titled "A Study of RGLS8429 in Healthy Volunteers". Primary Objective • To assess the safety and tolerability of single ascending doses of RGLS8429 Secondary Objectives * To identify dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) of a single SC dose of RGLS8429 * To characterize the pharmacokinetic (PK) properties o...
What is the current status of trial NCT05429073?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2022-06-10. Estimated completion is 2022-09-08.
What conditions does trial NCT05429073 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT05429073?
The interventions under investigation include: RGLS8429 (DRUG), Placebo volume-matching RGLS8429 dose (DRUG).
Who is sponsoring clinical trial NCT05429073?
This trial is sponsored by Regulus Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05429073 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05429073's enrollment target sits among peer trials
32 171st of 283 higher than 99 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
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