Actively Recruiting
A Study to Evaluate the 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
68 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of repeated doses of SRN001 in healthy adult volunteers.
CONDITIONS
Official Title
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Caucasian Adult Males
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy Korean or Caucasian male volunteers aged 19 to 60 years at screening
- Weigh 50 kg or more with a body mass index between 18.5 and 29.9 kg/m2
- Serum amphiregulin concentration of 100 pg/mL or higher at screening
- Voluntarily agree to participate and provide written informed consent
You will not qualify if you...
- History or presence of significant diseases affecting liver, kidney, nervous, immune, respiratory, digestive, endocrine, blood, heart, urinary, psychiatric systems, or sexual dysfunction
- History of hypersensitivity to RNA drugs or other drugs, or significant allergic reactions
- Positive tests for hepatitis B, hepatitis C, HIV, or syphilis
- History of drug abuse or positive urine drug screen
- Abnormal vital signs including low or high blood pressure, pulse rate, or body temperature
- Abnormal electrocardiogram findings such as QTcF greater than 450 msec
- Elevated liver enzymes or reduced kidney function based on lab tests
- Recent use of prescription, over-the-counter drugs, herbal medicines, or supplements within 1-2 weeks before dosing
- Use of enzyme inducers or inhibitors like barbiturates or clarithromycin within one month before dosing
- Participation in another clinical trial or receipt of investigational drug within 6 months
- Recent blood donation or transfusion
- Current smokers or unable to quit smoking before and during the trial
- Regular alcohol consumption exceeding limits or inability to abstain before and during the trial
- Excessive caffeine intake or inability to abstain before and during the trial
- Consumption of grapefruit or grapefruit-containing foods before and during the trial
- Unusual eating habits or inability to follow standardized diet during hospitalization
- Use of own condoms during the trial or partners not using effective contraception
- Refusal to abstain from sperm donation during the trial
- Any other condition deemed unsuitable by the investigator for trial participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
Research Team
E
Eunkyeong Woo
CONTACT
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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