NCT05429073

A Study of RGLS8429 in Healthy Volunteers

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Regulus Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	RGLS8429	solution for subcutaneous injection
DRUG	Placebo volume-matching RGLS8429 dose	solution for subcutaneous injection

Timeline

• Start date: 2022-06-10
• Primary completion: 2022-09-08
• Completion: 2022-09-08
• First posted: 2022-06-23
• Last updated: 2025-08-27
• Results posted: 2025-08-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study