Asymptomatic

Researchers are evaluating the use of [18F]FT8, a diagnostic imaging agent, for detecting amyloidosis, including cardiac amyloidosis. This study aims to assess the safety and effectiveness of [18F]FT8 PET/CT 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 [18F]FT8, followed by a PET/CT 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 PET/CT scan. Researchers will monitor safety from the time of injection up to seven days afterward, and evaluate organ uptake and biodistribution of [18F]FT8 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-201's 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 the safety and tolerability of ABBV-932 in healthy adult male participants. This Phase 1 study focuses on how the body absorbs, processes, and eliminates a single oral dose of ABBV-932, a drug given to volunteers without any known health conditions. The study is sponsored by AbbVie and aims to gather important data on the drug’s behavior in the body. Participants will receive one oral dose of ABBV-932 on the first day of the study. The trial is designed to observe this single administration without any placebo or comparison group. The study period includes monitoring for up to approximately 86 days to assess drug levels and effects over time. During the study, participants will undergo various assessments including measuring the maximum concentration of ABBV-932 in the blood, the time it takes to reach this peak level, and how quickly the drug is eliminated from the body. Researchers will also track any adverse events for up to around 103 days after dosing. Participation will last over this extended period to ensure thorough safety and tolerability evaluations.

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 clinical trial to evaluate the safety and how the body processes two oral drugs, ABBV-722 and Upadacitinib, in healthy adult volunteers. The study aims to understand the interaction between these drugs when given multiple doses and to monitor any side effects that may occur. Participants will receive multiple oral doses of Upadacitinib, ABBV-722, or a combination of both during different periods of the study. The trial includes several groups and treatment periods, with dosing schedules extending up to 17 days in some periods. Healthy adults will be monitored closely throughout these treatment phases. During the study, participants will undergo various assessments including blood tests to measure drug levels in the body at different times, physical exams, vital sign checks, and ECGs. Researchers will track any adverse events for up to 91 days to evaluate safety. The study lasts several weeks, involving careful monitoring of how the drugs behave in the body and their safety profile.

Researchers are evaluating how repeated doses of ABBV-722 affect the levels of ethinyl estradiol and levonorgestrel, which are components of a combined oral contraceptive, in healthy adult female participants. This Phase 1 study aims to understand the drug interactions and pharmacokinetics to ensure safe and effective use. The study is sponsored by AbbVie and involves healthy volunteers aged 18 to 65 years. The study consists of two periods. In Period 1, participants receive a single dose of ethinyl estradiol and levonorgestrel to establish baseline drug levels. In Period 2, participants take multiple daily doses of ABBV-722 alongside a single dose of ethinyl estradiol and levonorgestrel to observe how ABBV-722 influences the pharmacokinetics of the contraceptive drugs. Participants will be monitored for various pharmacokinetic measures such as maximum plasma concentration, time to maximum concentration, elimination rate, half-life, and plasma concentration over time for both ethinyl estradiol and levonorgestrel. Safety is assessed by tracking adverse events for up to approximately 82 days. The study involves medical history review, physical exams, laboratory tests, vital signs, and ECGs to ensure participant health throughout the trial.

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.