Phase 1
N=32
A Study of RGLS8429 in Healthy Volunteers
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT05429073 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Incidence of Adverse Events (AEs) — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- RGLS8429 (Drug); Placebo volume-matching RGLS8429 dose (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regulus Therapeutics Inc.
- Primary completion
- Sep 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Adverse Events (AEs) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Incidence of DLT and Determination of MTD |
— | — |
| SECONDARY Plasma Half-life (T1/2) of RGLS8429 |
— | — |
| SECONDARY Plasma Clearance of RGLS8429 |
— | — |
| SECONDARY Area Under the Plasma Concentration vs Time Curve (AUC) of RGLS8429 |
— | — |
| SECONDARY Amount of RGLS8429 Excreted in Urine |
— | — |
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
Eligibility Criteria
Inclusion Criteria
- Male or female, 18 to 55 years of age
- Body mass index (BMI) 18 to 35 kg/m2
- Medically healthy, with no clinically significant medical history in the opinion of the Investigator
- Estimated glomerular filtration rate (eGFR) ≥ 90 mL/min/1.73 m2
- Must understand and consent to the study procedures explained in the informed consent form (ICF) and be willing and able to comply with the protocol
Exclusion Criteria
- Subject is mentally incapacitated or has significant emotional problems
- Any medical condition or social circumstance that, in the opinion of the Investigator, may make the subject unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the subject's safety
- History or presence of alcoholism or drug abuse within the past 2 years prior to Screening
- Participation in another clinical trial and/or exposure to any investigational drug or approved therapy for investigational use within 28 days or 5 half-lives of the investigational drug's dosing, whichever is longer, prior to dosing. The 28-day and 5-half-life windows will be calculated from the date of the last dosing in the previous study to Day 1 of the current study.
Data sourced from ClinicalTrials.gov (NCT05429073). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.