BridgeMD
Tests treatment safety and results for Idiopathic Pulmonary Fibrosis
Official title A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SRN001 in Healthy Korean and Caucasian Adult Males
ClinicalTrials.gov ID: NCT07407543
What this study is testing
What is SRN001?
SRN001 is an investigational medicine, being studied as a potential treatment for idiopathic pulmonary fibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- To evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of repeated doses of SRN001 in healthy adult volunteers.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 60, men only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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...
You likely can't join if
- Those with or have a history of clinically significant diseases of the hepatobiliary system (severe liver failure, viral hepatitis, etc.), kidney...
- Those with a history of hypersensitivity to RNA drugs or other drugs (aspirin, antibiotics, etc.) or a history of clinically significant...
- 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
See the full eligibility criteria
- 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...
- 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...
- 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
- Diastolic blood pressure \< 45 mmHg or ≥ 90 mmHg
- Pulse \ 100 bpm
- Body temperature \ 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...
- 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...
- Smokers (however, people may be selected as people 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...
- 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...
- 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.)...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 19 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.