Idiopathic Pulmonary FibrosisPhase 1NCT07407543
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Caucasian Adult Males
A Phase 1 study testing SRN001 and 0.9% sodium chloride (normal saline) in people with Idiopathic Pulmonary Fibrosis, run by siRNAgen Therapeutics Inc. at 1 site in South Korea.
Trial summary
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of repeated doses of SRN001 in healthy adult volunteers. Read more about this study
- Who is it for?
- Ages 19 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- What is being tested?
- SRN001 and 0.9% sodium chloride (normal saline)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 5 Jan 2026to 30 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Korean or Caucasian male volunteers aged 19 to 60 years at the time of screening.
- 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
- Those whose screening results showed a serum amphiregulin concentration of 100 pg/mL or higher.
- 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.
Who cannot join
- 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.
- 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.).
- Those with a positive serum test result (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test).
- Those with a history of drug abuse or a positive urine drug screening test for drugs of abuse.
- 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
Show all 27Show fewer
- Diastolic blood pressure < 45 mmHg or ≥ 90 mmHg
- Pulse < 45 bpm or > 100 bpm
- Body temperature < 35.5 ℃ or > 37.7 ℃
- Those who exhibited the following values or clinically significant abnormal rhythm findings on the electrocardiogram (12-lead ECG) during the screening test:
- -QTcF > 450 msec
- Those who exhibited one or more of the following results in clinical laboratory tests during the screening test, including additional tests:
- AST (SGOT) or ALT (SGPT) > 60 IU/L
- Estimated glomerular filtration rate (CKD-EPI equation) < 60 mL/min/1.73 m2
- Those who have taken any prescription drugs or herbal medicines within two weeks prior to the scheduled first administration of the investigational drug, or have taken any over-the-counter drugs, health functional foods including liver function supplements, or vitamin preparations within one week (however, at the investigator's discretion, subjects may be selected as subjects if other conditions are appropriate) or are expected to take such drugs.
- Those who have taken drug-metabolizing enzyme inducers such as barbiturates or drug metabolism inhibitors such as clarithromycin within one month prior to the scheduled first administration of the investigational drug.
- Those who have participated in another clinical trial (including bioequivalence trials) and received the investigational drug within six months prior to the scheduled first administration of the investigational drug.
- Those who have donated whole blood within two months prior to the scheduled first administration of the investigational drug, or have donated blood components within one month prior to the scheduled first administration of the investigational drug, or have received a blood transfusion.
- Smokers (however, subjects may be selected as subjects if they quit smoking three months prior to the scheduled first administration of the investigational drug) or those who are unable to quit smoking until the completion of the clinical trial.
- Those who have continuously consumed alcohol (21 units/week, 1 unit = 10 g of pure alcohol) or cannot abstain from alcohol from 3 days before the scheduled first dose of the investigational drug until the end of the clinical trial.
- Those who have continuously consumed excessive caffeine (more than 5 units/day, 1 unit = 80 mg of caffeine) or cannot abstain from consuming caffeinated foods and beverages (coffee, tea (black tea, green tea, etc.), carbonated beverages, coffee drinks, coffee milk, tonic drinks, energy drinks, etc.) from 3 days before the scheduled first dose of the investigational drug until the end of the clinical trial.
- Those who cannot abstain from consuming grapefruit (grapefruit), grapefruit juice, or grapefruit-containing foods from 3 days before the scheduled first dose of the investigational drug until the end of the clinical trial.
- Those who have unusual eating habits (e.g., consuming more than 1 L of grapefruit juice per day) or cannot consume the standardized diet provided by the clinical trial center during their hospitalization.
- Those who use their own condoms from 3 days before the scheduled first dose of the investigational drug until the end of the clinical trial. Women of childbearing potential (spouse or partner) who do not consent to a contraceptive method considered highly effective.
- [Contraceptive methods considered highly effective]
- Those who do not agree to refrain from donating sperm from 3 days prior to the scheduled first dose of the investigational drug until the end of the clinical trial.
- Those whom the investigator determines to be unsuitable for clinical trial participation for reasons other than those listed above.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
InJin Jang, +82-10-7573-2458, ijjang@snu.ac.kr
About this study
Official title: 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
To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of repeated doses of SRN001 in healthy adult volunteers.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Being tested
- SRN001, 0.9% sodium chloride (normal saline)
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SRN001Drug
SRN001 is an investigational drug administered at doses of 45 mg, 90 mg, or 180 mg depending on cohort.
0.9% sodium chloride (normal saline)Drug
0.9% sodium chloride solution administered as placebo control.
| Study group | Role | What they receive |
|---|---|---|
| cohort1 Drug: SRN001 45mg | Experimental | cohort1 Drug: SRN001 45mg Receives: Drug: SRN001 |
| cohort2 Drug: SRN001 90mg | Experimental | cohort2 Drug: SRN001 90mg Receives: Drug: SRN001 |
| cohort3 Drug: SRN001 180mg | Experimental | cohort3 Drug: SRN001 180mg Receives: Drug: SRN001 |
| Placebo Comparator | Placebo comparator | Participants receive placebo (0.9% sodium chloride, normal saline) Receives: Drug: 0.9% sodium chloride (normal saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Number of participants experiencing one or more TEAEs during the study period.
Measured: From first dose through end of study (up to 114 days)
Number of participants with serious adverse events (SAEs)
Number of participants with SAEs as defined in protocol.
Measured: From first dose through end of study (up to 114 days)
Number of participants with clinically significant abnormal laboratory results
Counts of clinically significant abnormal lab tests during study.
Measured: From first dose through end of study (up to 114 days)
Maximum Observed Plasma Concentration (Cmax) of SRN001
Maximum observed plasma concentration (Cmax) following IV administration of SRN001.
Measured: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose)
Time to Maximum Plasma Concentration (Tmax) of SRN001
Time to reach maximum observed plasma concentration following IV administration.
Measured: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Area Under the Curve from time zero to last measurable concentration (AUClast)
AUClast of SRN001 plasma concentration versus time curve.
Measured: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Area Under the Plasma Concentration-Time Curve over the Dosing Interval (AUCtau) of SRN001
AUCtau will be calculated as the area under the plasma concentration versus time curve over one complete dosing interval following multiple escalating intravenous doses of SRN001.
Measured: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Terminal Half-Life (t½) of SRN001
Terminal elimination half-life (t½) will be calculated from the plasma concentration-time profile at steady state following multiple doses.
Measured: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Clearance (CL) of SRN001
Systemic clearance (CL) will be determined from non-compartmental analysis of plasma concentrations at steady state after multiple dosing.
Measured: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Apparent Volume of Distribution (Vz) of SRN001
Apparent volume of distribution (Vz) will be calculated from plasma concentration data at steady state following multiple doses.
Measured: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Time to Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of SRN001
Time to reach maximum observed plasma concentration at steady state following multiple intravenous doses.
Measured: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of SRN001
Maximum observed plasma concentration at steady state following multiple intravenous doses.
Measured: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Minimum Observed Plasma Concentration at Steady State (Cmin,ss) of SRN001
Minimum observed plasma concentration at steady state following multiple doses.
Measured: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Average Plasma Concentration at Steady State (Cavg,ss) of SRN001
Average plasma concentration at steady state following multiple intravenous doses.
Measured: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Trough Plasma Concentration at Steady State (Ctrough) of SRN001
Plasma concentration just prior to the next dose at steady state following multiple dosing.
Measured: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Area Under the Plasma Concentration-Time Curve over the Dosing Interval at Steady State (AUCtau,ss) of SRN001
AUCtau,ss will be calculated over one dosing interval at steady state following multiple intravenous doses.
Measured: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Peak-to-Trough Fluctuation (PTF) of SRN001 at Steady State Description: Peak-to-trough fluctuation in plasma concentration at steady state, defined as (Cmax,ss - Cmin,ss)/Cavg,ss.
Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose)
Measured: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Accumulation Ratio (R) of SRN001 at Steady State
Accumulation ratio (R) comparing exposure at steady state with that after the first dose (e.g., based on Cmax or AUC).
Measured: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start5 Jan 2026
- Primary completion31 Oct 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Idiopathic Pulmonary FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- siRNAgen Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07407543
- Sponsor's protocol ID
- SRN001-CA-25001A
- Status last verified
- Feb 2026
- First submitted
- 5 Jan 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yoon PO, Park JW, Lee CM, Kim SH, Kim HN, Ko Y, Bae SJ, Yun S, Park JH, Kwon T, Kim WS, Lee J, Lu Q, Kang HR, Cho WK, Elias JA, Yang JS, Park HO, Lee K, Lee CG. Self-assembled Micelle Interfering RNA for Effective and Safe Targeting of Dysregulated Genes in Pulmonary Fibrosis. J Biol Chem. 2016 Mar 18;291(12):6433-46. doi: 10.1074/jbc.M115.693671. Epub 2016 Jan 27.
PubMed 26817844
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07407543
- Acronym / sponsor ID
- SRN001-CA-25001A
- Conditions
- Idiopathic Pulmonary Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- siRNAgen Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Jan 2026 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 12 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cohort1 Drug: SRN001 45mg | Experimental | Drug: SRN001cohort1 Drug: SRN001 45mg |
| cohort2 Drug: SRN001 90mg | Experimental | Drug: SRN001cohort2 Drug: SRN001 90mg |
| cohort3 Drug: SRN001 180mg | Experimental | Drug: SRN001cohort3 Drug: SRN001 180mg |
| Placebo Comparator | Placebo comparator | Drug: 0.9% sodium chloride (normal saline)Participants receive placebo (0.9% sodium chloride, normal saline) |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Korean or Caucasian male volunteers aged 19 to 60 years at the time of screening.
- 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
- Those whose screening results showed a serum amphiregulin concentration of 100 pg/mL or higher.
- 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.
Key exclusion criteria (27 listed)
- 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.
- 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.).
- Those with a positive serum test result (hepatitis B test, hepatitis C test, human immunodeficiency virus (HIV) test, syphilis test).
- Those with a history of drug abuse or a positive urine drug screening test for drugs of abuse.
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SRN001SRN001 is an investigational drug administered at doses of 45 mg, 90 mg, or 180 mg depending on cohort. | Drug | cohort1 Drug: SRN001 45mg, cohort2 Drug: SRN001 90mg, cohort3 Drug: SRN001 180mg |
| 0.9% sodium chloride (normal saline)0.9% sodium chloride solution administered as placebo control. | Drug | Placebo Comparator |
Primary outcome
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose through end of study (up to 114 days)
Number of participants experiencing one or more TEAEs during the study period.
Number of participants with serious adverse events (SAEs)
Time frame: From first dose through end of study (up to 114 days)
Number of participants with SAEs as defined in protocol.
Number of participants with clinically significant abnormal laboratory results
Time frame: From first dose through end of study (up to 114 days)
Counts of clinically significant abnormal lab tests during study.
Maximum Observed Plasma Concentration (Cmax) of SRN001
Time frame: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose)
Maximum observed plasma concentration (Cmax) following IV administration of SRN001.
Time to Maximum Plasma Concentration (Tmax) of SRN001
Time frame: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Time to reach maximum observed plasma concentration following IV administration.
Area Under the Curve from time zero to last measurable concentration (AUClast)
Time frame: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
AUClast of SRN001 plasma concentration versus time curve.
Area Under the Plasma Concentration-Time Curve over the Dosing Interval (AUCtau) of SRN001
Time frame: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
AUCtau will be calculated as the area under the plasma concentration versus time curve over one complete dosing interval following multiple escalating intravenous doses of SRN001.
Terminal Half-Life (t½) of SRN001
Time frame: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Terminal elimination half-life (t½) will be calculated from the plasma concentration-time profile at steady state following multiple doses.
Clearance (CL) of SRN001
Time frame: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Systemic clearance (CL) will be determined from non-compartmental analysis of plasma concentrations at steady state after multiple dosing.
Apparent Volume of Distribution (Vz) of SRN001
Time frame: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Apparent volume of distribution (Vz) will be calculated from plasma concentration data at steady state following multiple doses.
Time to Maximum Observed Plasma Concentration at Steady State (Tmax,ss) of SRN001
Time frame: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Time to reach maximum observed plasma concentration at steady state following multiple intravenous doses.
Maximum Observed Plasma Concentration at Steady State (Cmax,ss) of SRN001
Time frame: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Maximum observed plasma concentration at steady state following multiple intravenous doses.
Minimum Observed Plasma Concentration at Steady State (Cmin,ss) of SRN001
Time frame: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Minimum observed plasma concentration at steady state following multiple doses.
Average Plasma Concentration at Steady State (Cavg,ss) of SRN001
Time frame: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Average plasma concentration at steady state following multiple intravenous doses.
Trough Plasma Concentration at Steady State (Ctrough) of SRN001
Time frame: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Plasma concentration just prior to the next dose at steady state following multiple dosing.
Area Under the Plasma Concentration-Time Curve over the Dosing Interval at Steady State (AUCtau,ss) of SRN001
Time frame: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
AUCtau,ss will be calculated over one dosing interval at steady state following multiple intravenous doses.
Peak-to-Trough Fluctuation (PTF) of SRN001 at Steady State Description: Peak-to-trough fluctuation in plasma concentration at steady state, defined as (Cmax,ss - Cmin,ss)/Cavg,ss.
Time frame: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose)
Accumulation Ratio (R) of SRN001 at Steady State
Time frame: Pre-dose samples: Day 1, Day 15, and Day 29 (pre-dose) Post-dose samples (Day 1 and Day 29): 0 (end of infusion), 10, 20, 30, and 45 minutes, and 1, 1.5, 2, 3, 6, 12, 24, and 48 hours after dosing
Accumulation ratio (R) comparing exposure at steady state with that after the first dose (e.g., based on Cmax or AUC).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Background: PubMed 26817844Yoon PO, Park JW, Lee CM, Kim SH, Kim HN, Ko Y, Bae SJ, Yun S, Park JH, Kwon T, Kim WS, Lee J, Lu Q, Kang HR, Cho WK, Elias JA, Yang JS, Park HO, Lee K, Lee CG. Self-assembled Micelle Interfering RNA for Effective and Safe Targeting of Dysregulated Genes in Pulmonary Fibrosis. J Biol Chem. 2016 Mar 18;291(12):6433-46. doi: 10.1074/jbc.M115.693671. Epub 2016 Jan 27.
- Related InfoLink provided by the sponsor.
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RecruitingPhase 2
A Phase 2 Study of LTI-03 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Not yet recruitingPhase 2
A Phase 2 Study of HB0056 in Patients With Idiopathic Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis (IPF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SRN001 and 0.9% sodium chloride (normal saline) in people with Idiopathic Pulmonary Fibrosis, run by siRNAgen Therapeutics Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eunkyeong Woo (+82-42-930-8654, wek@sirnagen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (TEAEs) (time frame: From first dose through end of study (up to 114 days)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07407543, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.