A Study of RGLS8429 in Healthy Volunteers

Regulus Therapeutics

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Placebo volume-matching RGLS8429 dose; Drug: RGLS8429

Study type: Interventional

Funder types: Industry

Identifiers

NCT05429073

RGLS8429-01

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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32 participants in 4 patient groups

RGLS8429, first dose level

Experimental group

Description:

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

Treatment:

Drug: Placebo volume-matching RGLS8429 dose

Drug: RGLS8429

RGLS8429, second dose level

Experimental group

Description:

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

Treatment:

Drug: Placebo volume-matching RGLS8429 dose

Drug: RGLS8429

RGLS8429, third dose level

Experimental group

Description:

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

Treatment:

Drug: Placebo volume-matching RGLS8429 dose

Drug: RGLS8429

RGLS8429, fourth dose level

Experimental group

Description:

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

Treatment:

Drug: Placebo volume-matching RGLS8429 dose

Drug: RGLS8429