A Study of RGLS8429 in Healthy Volunteers

Healthy Volunteers Clinical Trial

Official title:

A Phase 1, Double-Blind, Placebo-Controlled, Single Ascending Dose Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of RGLS8429

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05429073
• Other study ID #: RGLS8429-01
• Status: Completed
• Phase: Phase 1
• Start date: June 10, 2022
• Est. completion date: September 8, 2022

Study information

• Verified date: October 2022
• Source: Regulus Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 evaluate the safety, tolerability, and PK of RGLS8429.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 8, 2022
• Est. primary completion date: September 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Male or female, 18 to 55 years of age

2. Body mass index (BMI) 18 to 35 kg/m2

3. Medically healthy, with no clinically significant medical history in the opinion of the Investigator

4. Estimated glomerular filtration rate (eGFR) = 90 mL/min/1.73 m2

5. 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:

1. Subject is mentally incapacitated or has significant emotional problems

2. 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

3. History or presence of alcoholism or drug abuse within the past 2 years prior to Screening

4. 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.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• RGLS8429
solution for subcutaneous injection
• Placebo volume-matching RGLS8429 dose
solution for subcutaneous injection

Locations

Country	Name	City	State
United States	ICON Early Phase Services	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Regulus Therapeutics Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)	Incidence and severity of adverse events after administration of RGLS8429	Baseline to Day 29
Secondary	Incidence of DLT and determination of MTD	Identify dose limiting toxicity and the maximum tolerated dose after RGLS8429 administration	Baseline to Day 29
Secondary	Plasma half-life (T1/2) of RGLS8429	Measure plasma elimination half-life after RGLS8429 administration	Baseline to Day 15
Secondary	Plasma clearance of RGLS8429	Measure plasma clearance after RGLS8429 administration	Baseline to Day 15
Secondary	Area under the plasma concentration vs time curve (AUC) of RGLS8429	Measure area under the plasma concentration vs time curve after RGLS8429 administration	Baseline to Day 15
Secondary	Amount of RGLS8429 excreted in urine	Measure the amount of RGLS8429 excreted in urine after RGLS8429 administration	Baseline to 24-hour