Phase 1 Study to Assess Safety, Tolerability, and Effects of Multiple Doses of SRN001 in Healthy Korean and Caucasian Adult Males Aged 19 to 60

What this Trial Is About

Researchers are studying SRN001, a new small interfering RNA drug designed to reduce fibrosis by targeting amphiregulin, a growth factor involved in fibroblast activity in lung and kidney tissues. This phase 1 clinical trial aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of repeated SRN001 doses in healthy adult males who are Korean or Caucasian. Participants will receive one of three doses of SRN001 45 mg, 90 mg, or 180 mg or a placebo 0.9% sodium chloride solution in a randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation study. The trial compares these groups to understand how SRN001 is processed in the body and its effects at different dose levels. During the study, participants will be monitored for treatment-emergent adverse events, serious adverse events, and abnormal lab results over up to 114 days. Blood samples will be collected at specific times before and after dosing to measure drug concentration and pharmacokinetic parameters. The trial includes careful safety monitoring and evaluation of how the body absorbs, distributes, metabolizes, and eliminates SRN001.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Caucasian Adult Males