A Study of RGLS8429 in Healthy Volunteers
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy Volunteers
In brief
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
Key facts
- Study ID
- NCT05429073
- Run by
- Regulus Therapeutics Inc.
- People needed
- 32
- Starts
- 2022-06-10
- Expected to finish
- 2022-09-08
- Last updated by the study team
- 2025-08-27
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- ICON Early Phase Services — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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