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RECRUITINGPHASE1

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

A Randomized, Double-blind, Placebo-controlled, Multiple Doses, Dose-escalation Phase 1 Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Caucasian Adult Males

NCT07407543•siRNAgen Therapeutics Inc.

View on ClinicalTrials.gov

Summary

To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of repeated doses of SRN001 in healthy adult volunteers.

Detailed Description

SRN001 is a novel small interfering RNA (siRNA) drug being developed to treat fibrosis using Self Assembled Micelle inhibitory ribonucleic acid (SAMiRNA™) technology. Amphiregulin (AREG) is a growth factor involved in fibroblast proliferation and myofibroblast transformation which is the hallmark of fibrosis in lung and kidney tissues. AREG is a downstream gene overexpressed by Transforming growth factor-β (TGF-β) during fibrosis, promoting fibroblast to myofibroblast transition (FMT). SRN001 is designed to downregulate generating amphiregulin by RNA interference (RNAi). The goal of this clinical trial is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of SRN001 in healthy Korean and Caucasian adult males.

Eligibility

Age

19 - 60 years

Sex

MALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy Korean or Caucasian male volunteers aged 19 to 60 years at the time of screening.
•2. Those who weighed 50.0 kg or more at the time of screening and had a body mass index (BMI) between 18.5 kg/m2 and 29.9 kg/m2.
•Body mass index (BMI, kg/m2) = weight (kg) / {height (m2)} 2
•3. Those whose screening results showed a serum amphiregulin concentration of 100 pg/mL or higher.
•4. Those who voluntarily agreed to participate in this clinical trial after receiving a thorough explanation and fully understanding the clinical trial. Those who decided to participate and gave written consent to comply with the precautions.

Exclusion Criteria

•1. Those with or have a history of clinically significant diseases of the hepatobiliary system (severe liver failure, viral hepatitis, etc.), kidney (severe renal failure, etc.), nervous system, immune system, respiratory system, digestive system, endocrine system, hematological/oncological system, cardiovascular system (heart failure, torsades de pointes, etc.), urinary system, psychiatric system (mood disorder, obsessive-compulsive disorder, etc.), or sexual dysfunction.
•2. Those with a history of hypersensitivity to RNA drugs or other drugs (aspirin, antibiotics, etc.) or a history of clinically significant hypersensitivity reactions (atopy, asthma, etc.).
•3. Those with a positive serum test result (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test).
•4. Those with a history of drug abuse or a positive urine drug screening test for drugs of abuse.
•5. Those who were screened in a sitting position after resting for at least 3 minutes. Those who exhibited the following values in measured vital signs:
•* Systolic blood pressure \< 80 mmHg or ≥ 140 mmHg
•* Diastolic blood pressure \< 45 mmHg or ≥ 90 mmHg
•* Pulse \< 45 bpm or \> 100 bpm
•* Body temperature \< 35.5 ℃ or \> 37.7 ℃
•6. Those who exhibited the following values or clinically significant abnormal rhythm findings on the electrocardiogram (12-lead ECG) during the screening test:
+17 more criteria

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Key Dates

Start Date

January 5, 2026

Primary Completion Date

October 31, 2026

Completion Date

April 30, 2027

Last Updated

February 12, 2026

Enrollment

ESTIMATED participants

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

SRN001

DRUG

0.9% sodium chloride (normal saline)

DRUG

Contacts

Eunkyeong Woo

CONTACT

+82-42-930-8654 wek@sirnagen.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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