Self-assembled Micelle Interfering RNA for Effective and Safe Targeting of Dysregulated Genes in Pulmonary Fibrosis.
Pyoung Oh Yoon, Jin Wook Park, Chang-Min Lee...
https://pubmed.ncbi.nlm.nih.gov/26817844Actively Recruiting
Phase 1
Age: 19Years - 60Years
MALE
Healthy Volunteers
ID07407543
A Randomized, Double-blind, Placebo-controlled, Multiple Dose, Dose-escalation Phase 1 Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Caucasian Adult Males
Led by siRNAgen Therapeutics Inc. · Updated on 2026-02-12
30
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Caucasian Adult Males
Who Can Participate
Age: 19Years - 60Years
MALE
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Healthy Korean or Caucasian male volunteers aged 19 to 60 years at screening
- Weight of 50.0 kg or more with a body mass index (BMI) between 18.5 and 29.9 kg/m2
- Serum amphiregulin concentration of 100 pg/mL or higher
- Voluntary written consent to participate and comply with trial requirements
You will not qualify if you...
- History or presence of significant diseases affecting liver, kidney, nervous, immune, respiratory, digestive, endocrine, blood, heart, urinary, psychiatric, or sexual function
- History of hypersensitivity to RNA drugs or other drugs such as aspirin or antibiotics
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- History of drug abuse or positive urine drug screen
- Abnormal vital signs including blood pressure, pulse, or body temperature outside specified ranges
- Electrocardiogram abnormalities such as QTcF > 450 msec
- Abnormal lab results including elevated liver enzymes or low kidney function
- Use of prescription, herbal, or over-the-counter drugs within specific timeframes before dosing
- Use of enzyme inducers or inhibitors like barbiturates or clarithromycin within one month before dosing
- Participation in another clinical trial with investigational drugs within six months prior
- Recent blood donation or transfusion within set timeframes
- Current smoker or unable to quit smoking three months before dosing and through study end
- Continuous alcohol consumption above 21 units per week or inability to abstain from alcohol three days before dosing through study end
- Excessive caffeine consumption or inability to abstain from caffeine three days before dosing through study end
- Inability to avoid grapefruit or grapefruit-containing foods three days before dosing through study end
- Unusual eating habits or inability to consume standardized diet during hospitalization
- Use of own condoms or partner not using highly effective contraception during study
- Failure to agree to abstain from sperm donation three days before dosing through study end
- Any other condition making participation unsuitable as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 29 days
Participants receive multiple doses of the investigational drug SRN001 or placebo to evaluate safety, tolerability, and pharmacokinetics.
Visits on Day 1, Day 15, and Day 29 with additional blood sampling visits on Day 1 and Day 29 for pharmacokinetic assessments
Follow-up
Duration - Up to 85 days after treatment
Participants are monitored after the last dose for safety and adverse events.
Follow-up visits as scheduled up to end of study (up to 114 days total)
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
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Research Team
E
Eunkyeong Woo
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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