A Study of RGLS8429 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: RGLS8429; Drug: Placebo volume-matching RGLS8429 dose

• Registration Number: NCT05429073
• Lead Sponsor: Regulus Therapeutics Inc.

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 tolerated dose (MTD) of a single SC dose of RGLS8429

* To characterize the pharmacokinetic (PK) properties of RGLS8429

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 evaluate the safety, tolerability, and PK of RGLS8429.

Study Timeline

• Study First Submitted: 2022-05-26
• Study Start: 2022-06-10
• Study First Submitted QC: 2022-06-17
• Study First Posted: 2022-06-23
• Primary Completion: 2022-09-08
• Study Completion: 2022-09-08
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-12
• Last Update Posted: 2022-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
RGLS8429, first dose level	RGLS8429	Eligible participants will receive subcutaneous injection of the first dose level RGLS8429 or placebo
RGLS8429, first dose level	Placebo volume-matching RGLS8429 dose	Eligible participants will receive subcutaneous injection of the first dose level RGLS8429 or placebo
RGLS8429, second dose level	RGLS8429	Eligible participants will receive subcutaneous injection of the second dose level RGLS8429 or placebo
RGLS8429, second dose level	Placebo volume-matching RGLS8429 dose	Eligible participants will receive subcutaneous injection of the second dose level RGLS8429 or placebo
RGLS8429, third dose level	RGLS8429	Eligible participants will receive subcutaneous injection of the third dose level RGLS8429 or placebo
RGLS8429, third dose level	Placebo volume-matching RGLS8429 dose	Eligible participants will receive subcutaneous injection of the third dose level RGLS8429 or placebo
RGLS8429, fourth dose level	RGLS8429	Eligible participants will receive subcutaneous injection of the fourth dose level RGLS8429 or placebo
RGLS8429, fourth dose level	Placebo volume-matching RGLS8429 dose	Eligible participants will receive subcutaneous injection of the fourth dose level RGLS8429 or placebo

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs)	Baseline to Day 29	Incidence and severity of adverse events after administration of RGLS8429

Secondary Outcome Measures

Name	Time	Method
Incidence of DLT and determination of MTD	Baseline to Day 29	Identify dose limiting toxicity and the maximum tolerated dose after RGLS8429 administration
Plasma clearance of RGLS8429	Baseline to Day 15	Measure plasma clearance after RGLS8429 administration
Plasma half-life (T1/2) of RGLS8429	Baseline to Day 15	Measure plasma elimination half-life after RGLS8429 administration
Area under the plasma concentration vs time curve (AUC) of RGLS8429	Baseline to Day 15	Measure area under the plasma concentration vs time curve after RGLS8429 administration
Amount of RGLS8429 excreted in urine	Baseline to 24-hour	Measure the amount of RGLS8429 excreted in urine after RGLS8429 administration

Trial Locations

Locations (1)

ICON Early Phase Services; 🇺🇸 San Antonio, Texas, United States