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A Study of RGLS8429 in Health...

A Study of RGLS8429 in Healthy Volunteers

NCT ID: NCT05429073

Last Updated: 2025-08-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-10

Study Completion Date

2022-09-08

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

This will be a double-blinded, randomized, placebo-controlled study.

Study Groups

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RGLS8429, first dose level

Eligible participants will receive subcutaneous injection of the first dose level RGLS8429 or placebo

Group Type EXPERIMENTAL

RGLS8429

Intervention Type DRUG

solution for subcutaneous injection

Placebo volume-matching RGLS8429 dose

Intervention Type DRUG

solution for subcutaneous injection

RGLS8429, second dose level

Eligible participants will receive subcutaneous injection of the second dose level RGLS8429 or placebo

Group Type EXPERIMENTAL

RGLS8429

Intervention Type DRUG

solution for subcutaneous injection

Placebo volume-matching RGLS8429 dose

Intervention Type DRUG

solution for subcutaneous injection

RGLS8429, third dose level

Eligible participants will receive subcutaneous injection of the third dose level RGLS8429 or placebo

Group Type EXPERIMENTAL

RGLS8429

Intervention Type DRUG

solution for subcutaneous injection

Placebo volume-matching RGLS8429 dose

Intervention Type DRUG

solution for subcutaneous injection

RGLS8429, fourth dose level

Eligible participants will receive subcutaneous injection of the fourth dose level RGLS8429 or placebo

Group Type EXPERIMENTAL

RGLS8429

Intervention Type DRUG

solution for subcutaneous injection

Placebo volume-matching RGLS8429 dose

Intervention Type DRUG

solution for subcutaneous injection

Interventions

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RGLS8429

solution for subcutaneous injection

Intervention Type DRUG

Placebo volume-matching RGLS8429 dose

solution for subcutaneous injection

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regulus Therapeutics Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rekha Garg, MD

Role: STUDY_DIRECTOR

Regulus Therapeutics

Locations

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ICON Early Phase Services

San Antonio, Texas, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

Document Type: Statistical Analysis Plan

Other Identifiers

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RGLS8429-01

Identifier Type: -

Identifier Source: org_study_id

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