Asymptomatic

Researchers are evaluating the use of 18FFT8, a diagnostic imaging agent, for detecting amyloidosis, including cardiac amyloidosis. This study aims to assess the safety and effectiveness of 18FFT8 PETCT scans in visualizing AL amyloid deposits in the heart, comparing its performance to established clinical methods such as echocardiography, MRI, and laboratory tests. The goal is to establish a reliable PET imaging protocol for direct diagnosis and differentiation of AL amyloidosis. Participants will receive a single intravenous injection of 10 b1 3 mCi of 18FFT8, followed by a PETCT scan to measure organ uptake using the standardized uptake value SUV. The study includes both healthy volunteers and amyloidosis patients. The imaging and injection occur only once, and no additional treatments are administered. Clinical assessments and lab tests are done before and after the scan to monitor safety and gather diagnostic information. During the study, participants will undergo physical exams, cardiac function assessments, and tests of liver and kidney function before and after the PETCT scan. Researchers will monitor safety from the time of injection up to seven days afterward, and evaluate organ uptake and biodistribution of 18FFT8 at the time of the scan. Radiation exposure is also measured. Total participation involves a single visit for imaging and assessments, with follow-up safety monitoring over one week.

Researchers are evaluating the drug-drug interactions between HDM1002 and several commonly used medications, including metformin, empagliflozin, midazolam, valsartan, and warfarin, in overweight or obese adult subjects. The study aims to assess the safety and tolerability of these drugs when taken alone or together. This Phase I trial involves overweight or obese adults aged 18 to 45 years in good general health. Participants are grouped into two cohorts one focusing on the interaction between HDM1002 and metformin or empagliflozin, and the other on interactions between HDM1002 and midazolam, valsartan, or warfarin. All drugs are administered orally, with some given as single doses. The study follows a fixed-sequence, open-label design conducted at a single center. Throughout the study, participants will be monitored for pharmacokinetic parameters such as drug concentration over time AUC and Cmax over an average of 11 weeks. Safety assessments include recording adverse events and clinical evaluations like vital signs, ECGs, and laboratory tests. The study ensures thorough observation of how these drugs interact and affect the body during the trial period.

This research aims to evaluate the safety, tolerability, pharmacokinetics, and immune response of single and multiple doses of MT-201 in healthy adult volunteers. It is a first-in-human, phase 1 clinical trial designed to gather initial data on how MT-201 behaves in the body and its potential effects in a controlled setting. Participants will receive either single or multiple doses of MT-201 or a placebo, administered through intravenous or subcutaneous routes. The study includes randomized assignment to one of the four groups single ascending dose of MT-201, multiple ascending dose of MT-201, single ascending dose of placebo, or multiple ascending dose of placebo. Both dosing strategies will be carefully monitored to assess safety and tolerability. During the study, participants will be closely observed for any adverse events, with safety assessments conducted up to 40 weeks. Researchers will monitor vital signs, laboratory tests, and immune responses to understand MT-201s effects fully. The trial involves healthy volunteers aged between 19 and 55 years, who will be required to provide written consent and comply with study procedures throughout the duration of the trial.

Researchers are evaluating GTX-B001, a humanized bispecific antibody targeting proteins on mast cells, in a first-in-human phase 1 study. The trial aims to assess the safety, pharmacokinetics, and pharmacodynamics of a single dose of GTX-B001. It includes both healthy adults and patients with chronic inducible urticaria, specifically cold urticaria and symptomatic dermographism, who remain symptomatic despite antihistamine treatment. This study is randomized, double-blind, and placebo-controlled. The study has two parts Part A enrolls up to 48 healthy participants in five ascending dose cohorts, and Part B enrolls 24 patients with chronic inducible urticaria in two ascending dose cohorts. Participants in both parts are randomly assigned to receive a single intravenous infusion of either GTX-B001 at various doses or a placebo of normal saline. The treatment is administered on Day 1 with follow-up visits extending up to 12 weeks after dosing. Participants will undergo up to 9 visits including screening over 4 weeks and follow-up assessments for 12 weeks post-treatment. Safety is monitored by tracking adverse events, while pharmacokinetics and pharmacodynamics of GTX-B001 are evaluated. For patients in Part B, preliminary efficacy on urticaria signs and symptoms is also assessed. The total participation period covers screening, treatment, and post-treatment monitoring to ensure thorough safety and response evaluation.

Researchers are conducting a first-in-human, phase 1 clinical trial to study S-1117, a drug being tested in healthy adult volunteers. The study aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of S-1117. It is a randomized, placebo-controlled, double-blind trial sponsored by Seismic Therapeutic AU Pty Ltd, designed to collect important data on how the drug behaves in the human body. The trial is divided into two parts Part 1 involves single ascending doses SAD of S-1117, and Part 2 involves multiple ascending doses MAD. Both S-1117 and placebo are administered either subcutaneously or intravenously. Participants will receive varying doses to help assess how the drug is processed and tolerated over time. Participants will be monitored closely with assessments over approximately two months, including tracking any treatment-related adverse events. Researchers will measure drug levels in the blood, including maximum concentration, time to reach peak levels, elimination half-life, clearance, volume of distribution, and bioavailability. Immunologic responses, such as changes in immunoglobulin G and the development of antidrug antibodies, will also be evaluated. The study includes regular safety monitoring and follow-up to ensure participant well-being throughout the trial.

Researchers are evaluating S-4321 in this first-in-human, phase 1 clinical trial to gather information on its safety, tolerability, and how the body processes and responds to it. The study involves healthy adult volunteers and aims to provide initial data on potential effects and biological activity of S-4321 compared to a placebo. This randomized, double-blind, placebo-controlled study is sponsored by Seismic Therapeutic AU Pty Ltd and includes two parts to test different dosing schedules. The trial has two parts Part 1 where participants receive single ascending doses of S-4321 or placebo, and Part 2 where participants receive multiple ascending doses, administered either subcutaneously or intravenously. This design allows researchers to carefully monitor how the drug behaves in the body at different dose levels and over time. Both S-4321 and placebo are given under controlled conditions during these periods. Participants are closely monitored through various safety assessments and laboratory tests over about two months. The main focus is on any treatment-related adverse events. Researchers will also measure how much of the drug enters the bloodstream, how long it stays, and how it affects receptor occupancy. Additional evaluations include antibody response against the drug. Participants must be available for the entire study period and follow-up to ensure complete data collection.

Researchers are conducting a phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISM8969 in healthy adults, elderly participants, and obese adults at risk of cardiovascular disease. The study aims to understand how the drug is processed and tolerated in these populations. Participants will receive ISM8969 tablets or placebo orally in different groups. Healthy adults will be assigned to single ascending dose SAD cohorts with up to 6 dose levels or multiple ascending dose MAD cohorts for up to 14 days. Elderly participants and obese adults at cardiovascular risk will also receive ISM8969 or placebo up to 14 days. The study is conducted sequentially to evaluate single and multiple doses. During the study, participants will be monitored for adverse events, laboratory abnormalities, vital signs, physical exams, and ECG changes up to 14 days after the last dose. Pharmacokinetic measures such as drug concentration and clearance will be assessed at various time points. Safety assessments include suicide severity rating scores and changes in blood markers like high sensitivity C-reactive protein. The total participation time includes dosing and follow-up periods lasting up to several weeks.

Researchers are evaluating a Multi-Cancer Early Detection MCED platform using whole genome sequencing of circulating tumor DNA combined with machine learning. This prospective, multi-center observational study aims to validate this MCED platform for the early detection of invasive cancers. The study plans to enroll 4,000 subjects including cancer patients and healthy volunteers across up to 10 clinical institutions in South Korea. Participants include those diagnosed with invasive solid tumors at various stages before treatment and healthy volunteers scheduled for cancer screening tests. Blood samples and clinical information will be collected from all participants. The study does not involve experimental treatments but focuses on analyzing circulating DNA to detect cancer early. During the study, participants will provide blood samples and clinical data for analysis. Researchers will assess the diagnostic accuracy of the MCED platform by measuring the positive and negative predictive values for invasive cancer diagnosis and the concordance rate for predicting the cancer origin over a 36-month period. Participants will be monitored for up to three years to evaluate these outcomes.

Researchers are evaluating the recovery and lifespan of autologous red blood cells RBCs treated with the INTERCEPT Blood System for RBCs with AS-1 in healthy adult subjects. This Phase 2, randomized, controlled, single-blind study compares 35-day-old INTERCEPT-treated RBCs to untreated RBCs stored for the same period. The objective is to measure the 24-hour post-infusion recovery and the lifespan of these RBCs to assess their viability after storage and treatment. Participants will donate a unit of whole blood that is processed to produce RBC components treated either with the INTERCEPT Blood System Test group or untreated as per standard procedures Control group. These RBCs are stored at 1C to 6C for 35 days. On Day 35, subjects receive a single intravenous infusion of approximately 10 to 30 mL of their own radiolabeled RBCs. The study involves infusions of 51Cr-labeled RBCs from treated or untreated blood, alongside 99mTc-labeled fresh RBCs, to measure recovery and blood volume. Participants will provide multiple blood samples at various times after infusion to measure RBC recovery, volume, and lifespan up to 35 days post-infusion. Safety is monitored for 24 hours after blood donation and infusion, focusing on adverse events and transfusion reactions. Additional laboratory testing of RBC samples at different stages will evaluate in vitro RBC properties. The total study duration and detailed monitoring ensure comprehensive evaluation of RBC viability and safety.

Researchers are evaluating a new medicine called NNC9733-0001 for its potential to help people with type 2 diabetes manage high blood sugar levels. The study also includes healthy participants to compare safety and tolerance. This Phase 1 trial aims to assess how safe and tolerable the medicine is when given as a single dose. Participants will be randomly assigned to receive either the study medicine or a placebo, which contains no active medicine. The dose strength is determined by when the participant enters the study, and the medicine is given as one or up to four injections around the abdomen by medical staff. The total study duration is about 40 weeks 10 months. During the study, participants will be monitored for side effects and any low blood sugar events from dosing until the end of the study at week 36. Blood samples will be collected to measure how the medicine behaves in the body over 48 hours after dosing. Participants will have regular assessments including physical exams, vital signs, ECGs, and laboratory tests to track safety and how the medicine is processed. The study includes healthy volunteers and people with type 2 diabetes aged 18 to 64 years.