Boryeong Si

Researchers are evaluating the safety, tolerability, pharmacokinetics PK, pharmacodynamics PD, and efficacy of NS101, an anti-FAM19A5 antibody, in both healthy volunteers and patients with sudden sensorineural hearing loss SSNHL. This exploratory Phase 1b2a study aims to determine if multiple doses of NS101 are safe and tolerable and whether the treatment can help restore hearing in SSNHL patients who have not sufficiently improved after standard steroid therapy. The study includes a placebo control and uses a double-blind design to ensure unbiased results. Participants receive NS101 or placebo via intravenous infusion at doses of 15 mgkg or 30 mgkg administered every two weeks. Healthy volunteers receive treatment for 6 weeks, whereas SSNHL patients receive treatment for 12 weeks. The study has four groups two dose levels for healthy volunteers with active and placebo arms, and two groups for SSNHL patients receiving either NS101 or placebo. Treatments are given systematically, and participants are randomly assigned to the groups. Throughout the study, participants undergo frequent safety assessments to monitor changes from baseline at multiple time points, including days and weeks after treatment begins. Pharmacokinetic and immunological tests are also performed to track how the drug behaves in the body and its effects. Researchers measure hearing improvement and monitor tolerability closely. The study is expected to continue until January 2027, with participants involved in regular visits and evaluations during and after treatment.

Researchers are evaluating the treatment of anemia in patients with chronic kidney disease CKD who are on hemodialysis. This Phase III, investigator-blinded, randomized, multicenter study compares two drugs, efepoetin alfa and darbepoetin alfa, to see how well they maintain hemoglobin levels in these patients. The study aims to maintain hemoglobin between 10.0 gdL and 12.0 gdL, which is important for managing anemia in CKD. Participants will be randomly assigned in a 21 ratio to receive either efepoetin alfa or darbepoetin alfa. Both drugs are given by intravenous injection, typically after dialysis sessions. Efepoetin alfa is administered weekly from Day 1 to Week 28, with possible interval changes to one or two weeks from Week 29 to Week 52 based on investigator judgment. The study consists of three periods screening up to 28 days, treatment about 52 weeks, and a 4-week follow-up with phone contacts up to Week 56 or the last visit. During the study, participants will undergo regular assessments including hemoglobin level monitoring to evaluate the mean change between Week 20 and Week 28. Safety and efficacy are closely observed, with dosages adjusted to maintain target hemoglobin levels. Follow-up will include phone contacts to monitor participants up to Week 56. The total participation duration is approximately one year, starting from screening through treatment and follow-up.

Researchers are evaluating the safety and effectiveness of 48 weeks of daily oral treatment with ALG-000184 compared to tenofovir disproxil fumarate TDF in adults with chronic hepatitis B virus HBV infection. This Phase 2 randomized, double-blind, active-controlled study includes both untreated HBeAg-positive and HBeAg-negative adults. The study aims to understand how well these treatments control HBV infection and their safety profiles. Participants will receive either ALG-000184 or TDF tablets once daily for 48 weeks. After this double-blind period, all participants may continue treatment with open-label ALG-000184 for an additional 48 weeks, making a total treatment duration of 96 weeks. The study is divided into two parts, focusing separately on HBeAg-positive and HBeAg-negative subjects, with some taking part in an exploratory liver biopsy sub-study. Throughout the study, participants will undergo regular assessments including measuring HBV DNA levels to see if the virus is suppressed below a set detection limit at 48 weeks. Safety and tolerability will be monitored up to 96 weeks. Other evaluations include liver enzyme levels, viral resistance, and drug pharmacokinetics. The study involves blood tests, liver assessments, and ongoing monitoring to track treatment effects and participant health over nearly two years.

This trial evaluates the safety and effectiveness of GSK4532990 in adults aged 18 to 70 who have alcohol-related liver disease, including those with advanced chronic liver disease. The study aims to understand how this drug affects liver health, including changes in liver stiffness and liver disease severity over time, compared to a placebo. It is a phase 2, double-blind, placebo-controlled trial sponsored by GlaxoSmithKline. Participants will be assigned to receive one of four doses of GSK4532990 or a placebo. The study uses a sequential design where dosing and treatment effects are monitored closely. Treatment and safety assessments are conducted up to 8 weeks, with liver measurements taken at baseline and at 52 weeks to evaluate long-term effects. During the trial, participants will undergo regular safety evaluations including monitoring for adverse events, heart and vital sign checks, and laboratory tests. Liver stiffness and disease severity scores will be measured at the start and after one year. Additional blood tests will assess drug levels and liver function. The total study participation includes initial screening, treatment, and follow-up visits lasting up to 52 weeks.

This research focuses on patients who have had an Embolic Stroke of Undetermined Source ESUS and have received an Implantable Cardiac Monitor ICM. It evaluates the use of an artificial intelligence tool called SmartECG-AF, which analyzes standard 12-lead ECGs taken during normal heart rhythm to predict the risk of developing atrial fibrillation AF. The study aims to understand if this AI tool can help identify which patients are more likely to experience AF and major cardiovascular events after ESUS. Participants will be divided into two groups based on the AIs risk assessment a High Risk group and a Low to Intermediate Risk group. The study will follow these groups over time to compare the frequency and timing of AF events detected by the ICM. This multicenter, prospective study will also explore the relationship between the AI risk scores and the occurrence of major adverse cardiovascular events, helping to assess the value of AI-guided risk stratification. During the study, patients baseline ECGs will be analyzed by the AI algorithm, and their heart rhythm will be monitored continuously through the ICM. Researchers will track the time to AF events and record any major cardiovascular incidents over a follow-up period of up to 12 months. Participants will be monitored for safety and clinical outcomes, providing data on how well the AI tool predicts cardiac risks in this population.

Researchers are evaluating the use of CART BP Pro, a wearable cuffless blood pressure monitoring device, to guide blood pressure management in Korean adults with uncontrolled hypertension. This device uses photoplethysmography technology to provide continuous ambulatory blood pressure monitoring. The study compares this method to usual care based on office blood pressure measurements, aiming to assess whether CART BP Pro-guided treatment improves blood pressure control and safety. Participants with uncontrolled hypertension despite ongoing antihypertensive therapy will be randomly assigned to either a group managed using CART BP Pro data or a usual care group following conventional office measurements. Both groups will receive antihypertensive medications according to clinical guidelines, including drugs like angiotensin receptor blockers, calcium channel blockers, and thiazide diuretics. The study period includes 24 weeks of follow-up, with an optional extension to 48 weeks for further observation. During the trial, participants will have their blood pressure monitored continuously with the CART BP Pro device or measured in the office. Researchers will assess blood pressure control using 24-hour ambulatory blood pressure monitoring at 24 weeks and track safety by recording any treatment-emergent adverse events. Additional measures include blood pressure load, achievement of target blood pressure, daytime and nighttime blood pressure averages, and changes in office blood pressure. The study takes place at multiple centers and monitors participants closely for efficacy and safety outcomes.

Researchers are evaluating the clinical outcomes of stopping versus continuing antiplatelet therapy in patients with chronic coronary syndrome who have a high risk of bleeding HBR. The study focuses on patients treated with drug-coated balloon DCB angioplasty and standard dual antiplatelet therapy DAPT for 1 to 3 months, followed by maintenance of a single antiplatelet agent for at least one year. This trial explores whether lifelong antiplatelet therapy is necessary after DCB angioplasty in this population, as current evidence mainly involves patients with drug-eluting stents and acute conditions. Participants will be randomly assigned after one year from their DCB angioplasty procedure and standard DAPT. One group will discontinue antiplatelet therapy at randomization, including those still on DAPT, while the other group will continue lifelong antiplatelet monotherapy, either aspirin or clopidogrel, based on physician choice. The study compares these two approaches to better understand post-treatment management in high bleeding risk patients. During the trial, participants will be closely monitored for major bleeding events and other cardiovascular outcomes over one year following the last patient enrollment. Researchers will assess safety and clinical events such as myocardial infarction, death, and revascularization procedures. The study also includes ongoing evaluation of patient status to ensure adherence and track any complications or benefits from the different antiplatelet strategies.

Researchers are studying the safety and immune response of MG1111 BARICELA Inj. when used as a second varicella vaccination in healthy children aged 4 to 6 years who have previously received a first varicella vaccination. This Phase 2 clinical trial aims primarily to assess safety up to 42 days after vaccination and secondarily to evaluate immune responses and ongoing safety. The study is designed as a double-blind, randomized, multi-center trial comparing MG1111 with two other varicella vaccines, VARIVAX and Suduvax. Participants receive a single 0.5ml dose of their assigned vaccine by subcutaneous injection as the second varicella vaccination. The trial includes three groups MG1111, VARIVAX, and Suduvax arms, each receiving the same dose and method of administration. The study monitors participants closely for safety and immune response over multiple time points, including an initial 42-day period and extended monitoring for up to three years for immune markers and varicella-related events. During the study, children will be monitored for fever, local and systemic side effects, physical exams, and vital signs within 42 days post-vaccination. Serious adverse events are tracked for up to one year. Blood samples will be taken to assess antibody levels and cellular immune responses before vaccination and at 42 days post-vaccination, with additional antibody testing up to three years. Researchers also evaluate any varicella-like rash and virus genetics during the extended follow-up. Participation involves regular visits for assessments and safety monitoring throughout the study duration.

Researchers are evaluating whether the risk of major adverse cardiac events over two years differs between two methods of guiding Percutaneous Coronary Intervention PCI in patients with Left Main Coronary Artery LMCA disease. The study compares Fractional Flow Reserve FFR-guided PCI and angiography-guided PCI to understand which approach may better influence treatment decisions and outcomes for this condition. Participants will be randomly assigned to receive either FFR-guided PCI or angiography-guided PCI. Both procedures involve using drug-eluting stents to treat significant LMCA disease and may include patients with other coronary artery diseases. The study will monitor participants for two years after their procedure, capturing various heart-related events and treatment outcomes during this period. During the two-year follow-up, participants will have clinical visits and assessments to track events such as death, heart attacks, hospitalizations, repeat procedures, stroke, bleeding, and stent problems. Researchers will also evaluate hospital stay length, procedure details, heart function, quality of life related to angina and health, and medication use. The study aims to provide comprehensive information on the safety and effectiveness of both PCI guidance strategies over this time frame.

This research aims to evaluate a guideline-oriented approach to lipid lowering in patients hospitalized with Type I myocardial infarction across the Asia-Pacific region. The study uses a randomized, multi-phase design to compare an early multifaceted intervention against standard care, with a focus on improving lipid management and patient engagement. It is designed to reflect real-world clinical practice by embedding the intervention within routine care. Participants are randomly assigned to receive the intervention either early, at baseline continuing through 6 months, or late, after 6 months. The intervention includes a patient-and-clinician cholesterol score card to track LDL cholesterol levels, medication adherence, clinician decisions, and prescribed therapies. Additionally, risk stratification using a SMART Risk score and Lpa measurement is provided to both patients and their primary care clinicians. Those in the late group receive standard-of-care during the first 6 months, which involves regular lipid profile reporting to their general practitioner. Participants will be involved in follow-up visits during the study where the score card is updated and adherence, lipid levels, and treatment changes are monitored. Primary outcomes include the proportion of patients achieving LDL cholesterol levels below 1.4 mmolL at 6 months. Secondary outcomes assess lipid therapy intensification, statin use, and patient activation. The study spans 12 months, with the late group receiving the intervention after the initial 6-month control period, and ongoing follow-up to measure treatment effects and adherence.