Control Condition

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.

This trial studies the pharmacokinetics of casdatifan in healthy adults aged 18 to 55 years. It compares the absorption and concentration levels of a single 100 mg dose given as one tablet versus four 25 mg tablets under fasting conditions. The study also evaluates how food intake affects the drugs pharmacokinetics when the 100 mg dose is taken as four tablets with food. Participants receive casdatifan in three different ways four 25 mg tablets while fasting, one 100 mg tablet while fasting, and four 25 mg tablets after a meal. This crossover design allows each participant to receive all treatments in a randomized order, enabling direct comparison of absorption and drug levels. During the study, participants are monitored for up to 168 hours after each dose to measure drug concentration and how the body processes casdatifan. Researchers assess the peak concentration, time to peak, elimination rate, and total exposure to the drug. Safety is monitored by recording any adverse events for up to 43 days. The entire study is conducted with healthy volunteers, and participation lasts until all dosing and follow-up assessments are complete.

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 SV003s 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 body effects of single and multiple doses of ARO-033 compared to placebo in healthy adult volunteers aged 18 to 65. This Phase 1 study focuses on measuring how the body processes the drug, including pharmacokinetics and pharmacodynamics, to understand its potential impacts. Participants are randomly assigned to receive either a single subcutaneous injection of ARO-033 or placebo on Day 1 single-ascending dose, or two doses on Day 1 and Day 29 multiple-ascending dose. The study includes a parallel design with quadruple masking to compare these groups effectively while monitoring safety and drug behavior. During the study, participants undergo regular assessments for treatment-emergent adverse events up to Day 225. Blood and urine samples will be collected at specified times to measure drug concentrations and excretion. Overall participation lasts through the primary completion date, with close monitoring of safety, tolerability, and drug effects over several months.

Researchers are evaluating the safety, tolerability, and pharmacokinetics of Debio 1453P, a new oral drug, compared to placebo in healthy adults aged 18 to 55 years. This Phase 1 study aims to understand how the drug is processed in the body and its effects after single and repeated doses. The trial involves healthy adult volunteers without significant medical conditions. Participants will receive either Debio 1453P or a placebo in two parts first, a single oral dose on Day 1 in a sequential manner, and second, multiple oral doses from Day 1 to Day 5. The initial dose for the repeated dosing phase will be based on data from the single dose part. Both Debio 1453P and placebo are given as oral solutions. During the study, participants will be monitored for any treatment-emergent adverse events up to 15 months. Blood and urine samples will be collected before dosing and at multiple timepoints up to Day 12 to measure the concentration of Debio 1453P. The study includes randomization and quadruple masking to ensure unbiased results. Participants can expect regular assessments and safety monitoring throughout their involvement.

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 drugs behavior and tolerability under different conditions, with the total participation lasting several weeks.

Researchers are investigating how metabolism, body composition, and body surface area relate in both healthy individuals and those with metabolic conditions such as diabetes, obesity, renal disease, or cancer. The study aims to improve the accuracy of metabolic rate measurements, which have traditionally relied on simple formulas using height and weight, which may not work well for everyone. Participants will spend two days and one night in the hospital during each visit. They will provide medical history, answer questions about their activity, diet, and lifestyle, and consume a special diet. They will undergo various tests including breathing gas measurements while lying under a clear hood, body scanning on a padded table and with a 3D scanner, electrical signal speed testing through the body, hand strength measurement, and collection of blood and urine after drinking salty water. Participants may return up to eight times per year with at least two weeks between visits. During the study, participants will be evaluated through these tests and questionnaires to understand their resting energy expenditure and body measurements. The primary outcomes include comparing measured versus predicted body surface area and determining how measured body surface area relates to energy expenditure independent of body composition. The study will continue until July 2031, and participants health and ability to complete tests will be monitored throughout their involvement.

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.