Status:
COMPLETED
A Study of RGLS8429 in Healthy Volunteers
Lead Sponsor:
Regulus Therapeutics Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief 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 tolerate...
Detailed Description
In this randomized, double-blind, placebo-controlled Phase 1 study, a single ascending dose of RGLS8429 or placebo will be administered via subcutaneous (SC) injection to healthy volunteers to evaluat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2022
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT05429073
Start Date
June 10 2022
End Date
September 8 2022
Last Update
August 27 2025
Active Locations (1)
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1
ICON Early Phase Services
San Antonio, Texas, United States, 78209