Control Condition

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 safety, tolerability, and how the body processes SPH9788 tablets in healthy adult volunteers aged 18 to 45 years. This randomized, double-blind, placebo-controlled Phase I study aims to understand the effects of single and multiple increasing doses of SPH9788 in a healthy Chinese population. The study is sponsored by Shanghai Pharmaceuticals Holding Co., Ltd and focuses on monitoring any treatment-emergent or serious adverse events during the trial period. Participants will receive either SPH9788 tablets or a matching placebo, both given orally. The study involves administering single and multiple ascending doses to assess safety and pharmacokinetics, including measures such as time to maximum concentration (Tmax), maximum concentration (Cmax), and area under the curve (AUC). These treatments are carefully monitored over approximately one year. During the study, volunteers will undergo regular assessments to track safety and drug processing in the body. Researchers will observe adverse events and collect pharmacokinetic data through blood tests at set intervals. Participants must follow lifestyle restrictions and contraceptive use during the trial and for six months afterward. The total duration of participation includes screening, treatment, and follow-up to ensure thorough safety evaluation.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of SV003 in healthy adult participants aged 18 to 45 years. This randomized, double-blind, placebo-controlled Phase I clinical trial aims to understand how SV003 behaves in the body and its safety profile in individuals without active or chronic diseases. The study is sponsored by Shanghai Synvida Biotechnology Co., Ltd. and focuses on healthy volunteers. Participants will receive a single dose of either the study drug SV003 or a placebo. The trial uses a randomized assignment to one of these two groups and includes a double-blind design, meaning neither participants nor researchers know who receives which treatment during the study. The dosing involves a single administration, after which participants will be monitored. During the approximately three-month study period, participants will undergo regular assessments to track any treatment-emergent adverse events. Researchers will also measure pharmacokinetic parameters such as peak plasma concentration, peak time, area under the plasma concentration curve, half-life, and immunogenicity. Participants will be closely monitored for safety and tolerability throughout the study to gather comprehensive data on SV003's effects.

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.

Researchers are evaluating the safety, tolerability, and how the body processes Debio 1453P compared to a placebo in healthy adults. This Phase 1 trial is the first time Debio 1453P is given to humans, aiming to study different dose levels after single and multiple oral doses. The study focuses on monitoring any adverse events and measuring drug levels in blood and urine to better understand its effects. Participants will receive either Debio 1453P or a placebo orally. Initially, they will get a single dose on Day 1, followed by multiple doses from Day 1 to Day 5. The starting dose for the multiple-dose part will be based on data from the single-dose part. This approach helps researchers assess how the drug behaves with repeated dosing. During the study, participants will be closely monitored for any treatment-related side effects over a period of up to 15 months. Blood and urine samples will be collected before dosing and at multiple times afterward, up to Day 12, to measure the concentration of Debio 1453P. The trial involves healthy adults aged 18 to 55 and includes careful assessment to ensure safety and gather detailed pharmacokinetic data throughout the study.

Researchers are evaluating YH35995, a new drug being developed to treat neurological symptoms of Gaucher Disease type 3. This first-in-human, phase 1 study is randomized, double-blind, and placebo-controlled. It aims to assess the safety, tolerability, how the drug moves and acts in the body after single and multiple doses in healthy adult male participants aged 19 to 45 years. The study has two parts: Part A involves single ascending doses where participants receive a single oral dose of YH35995 or placebo in five increasing dose groups. Part B involves multiple ascending doses where participants take oral doses of YH35995 or placebo once every four weeks in three dose groups. Each part includes randomized groups receiving either the drug or placebo to compare effects. Participants will be monitored for treatment-emergent adverse events over approximately 150 days in Part A and 232 days in Part B. Researchers will also measure detailed pharmacokinetic and pharmacodynamic parameters, including drug concentration in plasma and cerebrospinal fluid, and drug effects over time. This comprehensive monitoring ensures thorough evaluation of safety and drug behavior throughout the study duration.

Researchers are studying how a high-fat, high-calorie meal affects the way the body absorbs Nalbuphine Extended-Release Tablets (NAL ER) after a single oral dose in healthy adults. This phase 1 study aims to understand the relative bioavailability of NAL ER under different dietary conditions. The research is sponsored by Trevi Therapeutics and involves healthy volunteers aged 18 to 60 years with normal body weight and medical health. Participants receive two different doses of NAL ER in a crossover design. They take one dose while fasting and another dose after eating a high-fat, high-calorie meal, with a 3-day break between doses. The study includes two sequences where the order of fasting and fed dosing is reversed, allowing comparison of how food impacts drug absorption. During the study, participants are monitored from Day 1 to Day 8 with blood samples taken at multiple times to measure drug levels, including peak concentration and how long the drug stays in the body. Safety is assessed by tracking any treatment-related side effects up to Day 18. This helps researchers understand the drug’s behavior and tolerability under different conditions, with the total participation lasting several weeks.

Researchers are studying how metabolism relates to body composition and body surface area (BSA) in a wide range of people, including healthy individuals and those with conditions like diabetes, obesity, kidney disease, or cancer. They aim to find more accurate ways to measure metabolism and understand how measured BSA compares to estimates based on height and weight. This observational natural history study is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Participants will spend 2 days and 1 night in the hospital for testing. They will provide medical history and information about their activity, diet, and lifestyle, and consume a special diet during the stay. Tests include lying under a clear hood to measure breath gases, body scanning while lying down and standing, measuring electrical signals through the body, hand strength tests, and providing blood and urine samples after drinking salty water. Participants may return for up to 8 such visits per year, with at least 2 weeks between visits. During the study, researchers will monitor resting energy expenditure, body composition, and BSA through these tests and questionnaires. They will track differences between measured and predicted BSA and how BSA relates to energy use. Safety and ability to complete tests are monitored, and the total participation time depends on the number of visits. This detailed assessment helps understand metabolism across health and disease states.

This research aims to study the effects of a single dose of AGA2118 in healthy Japanese, Chinese, and Caucasian adults aged 18 to 65 years. It is a Phase 1 ethnobridging trial designed to evaluate how the drug is processed and acts in the body (pharmacokinetics and pharmacodynamics), along with its safety in these different ethnic groups. The goal is to understand any differences in drug behavior among these populations. Participants will receive a single subcutaneous injection of AGA2118. Eighteen Japanese participants will be randomly assigned to receive one of three different doses to assess dose effects. After completing the Japanese dosing groups, six Caucasian and six Chinese participants will each receive the highest dose. The Caucasian group is matched to the Japanese participants by sex and weight. Participants will be followed for 85 days after dosing to monitor effects and safety. Throughout the 85-day study period, participants will have their blood sampled to measure drug levels and how the body processes the drug, including concentration peaks, clearance, and half-life. Safety will be assessed by monitoring any adverse events from baseline through the end of the study. This includes checking vitamin D levels and requiring calcium and vitamin D supplementation during the study. The total participation time is approximately three months, during which participants' health and response to AGA2118 will be closely monitored.

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.