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A Study of RGLS8429 in Healthy Volunteers

NCT05429073 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-08-27

Study results available
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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

Conditions

  • Healthy Volunteers

Interventions

DRUG

RGLS8429

solution for subcutaneous injection

DRUG

Placebo volume-matching RGLS8429 dose

solution for subcutaneous injection

Sponsors & Collaborators

  • Regulus Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Rekha Garg, MD · Regulus Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-10
Primary Completion
2022-09-08
Completion
2022-09-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05429073 on ClinicalTrials.gov