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Antisense Oligonucleotide

RGLS8429, first dose level for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Regulus Therapeutics Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to day 29
Awards & highlights

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to day 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to day 29 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (AEs)
Secondary outcome measures
Amount of RGLS8429 excreted in urine
Area under the plasma concentration vs time curve (AUC) of RGLS8429
Incidence of DLT and determination of MTD
+2 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: RGLS8429, third dose levelExperimental Treatment2 Interventions
Eligible participants will receive subcutaneous injection of the third dose level RGLS8429 or placebo
Group II: RGLS8429, second dose levelExperimental Treatment2 Interventions
Eligible participants will receive subcutaneous injection of the second dose level RGLS8429 or placebo
Group III: RGLS8429, fourth dose levelExperimental Treatment2 Interventions
Eligible participants will receive subcutaneous injection of the fourth dose level RGLS8429 or placebo
Group IV: RGLS8429, first dose levelExperimental Treatment2 Interventions
Eligible participants will receive subcutaneous injection of the first dose level RGLS8429 or placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RGLS8429
2022
Completed Phase 1
~40
Placebo volume-matching RGLS8429 dose
2022
Completed Phase 1
~40

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Regulus Therapeutics Inc.Lead Sponsor
2 Previous Clinical Trials
55 Total Patients Enrolled
Karl Cremer, PharmDStudy DirectorRegulus Therapeutics
1 Previous Clinical Trials
19 Total Patients Enrolled
Rekha Garg, MDStudy DirectorRegulus Therapeutics
1 Previous Clinical Trials
36 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What site did they apply to?
ICON Early Phase Services
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Average response time
  • < 2 Days
Typically responds via
Phone Call
Most responsive sites:
  1. ICON Early Phase Services: < 48 hours
Recent research and studies
clinicaltrials.govStudy
A Study of RGLS8429 in Healthy Volunteers
2022. "A Study of RGLS8429 in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05429073.
~13 spots leftby Apr 2025
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