Non-Smokers

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.

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 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 evaluating the SensMode System, a set of wearable devices designed to analyze upper and lower limb movements. This study involves healthy adults, subjects with idiopathic hyposmia, patients with Parkinsons disease, and individuals with newly diagnosed drug-nafve extrapyramidal syndrome. The goal is to establish normal ranges for objective motor measurements and explore how this technology might aid in early diagnosis and management of Parkinsons disease. Participants will use the SensMode System, which includes SensHand and SensFoot devices. SensHand consists of sensorized rings and a wristband that measure movement and orientation of the hand and forearm, while SensFoot is a device placed over the shoe to assess lower limb motion. All subjects undergo motor analysis using these sensors at enrollment. During the study, researchers will monitor various motor outcome measures such as the number of repetitions of specific movements, time to stand up, gait time, rotation time, fundamental frequencies from accelerometer signals, and stride count at enrollment. This data will help characterize motor function and support further research into Parkinsons disease diagnosis and care. The study runs from May 2024 to January 2026 and includes adults aged 50 to 80 years.

This trial investigates the safety and drug-drug interaction between DW4421 and three different nonsteroidal anti-inflammatory drugs NSAIDs in healthy adult volunteers. The study is a Phase 1 clinical trial designed to assess how these drugs interact in the body, focusing on their pharmacokinetics, which helps understand the drug levels and behavior over time. Participants will receive different forms of the investigational drug DW4421, administered once daily or twice daily depending on the variant DW4421, DW4421-N1, DW4421-N2, DW4421-N3. The study is randomized and includes several cohorts to evaluate these combinations carefully. Each participant will follow specific dosing schedules during the trial. During the trial, researchers will monitor participants closely through various assessments including measuring drug concentration peaks Cmax and overall exposure AUC from baseline to study days 13 or 15. Healthy volunteers aged 19 to 50 will be observed for any safety concerns or changes in how the drugs work together. The total study participation lasts from the start until the final assessments around day 15, with continuous monitoring of drug interactions and safety.

This trial studies healthy adult females not of childbearing potential, aiming to compare how Navlimetostat behaves in the body after taking two different tablet formulations a wet-granulation tablet and a dry-granulation tablet. The purpose is to assess the bioequivalence of these formulations, meaning whether they deliver the drug similarly. The study is a Phase 1, open-label, randomized crossover trial sponsored by Bristol-Myers Squibb. Participants will receive two treatments the wet-granulation and dry-granulation tablets of Navlimetostat, given in two separate periods. The study uses a crossover design where participants receive both treatments in a random order, allowing comparison within the same individual. Dosing occurs on specified days, and the study monitors pharmacokinetic parameters up to 17 days after dosing. During the study, participants will undergo evaluations including blood sampling to measure drug levels, physical examinations, vital signs, ECGs, and lab tests to monitor safety and effects. Researchers will track adverse events up to about 37 days. The main outcomes include peak drug concentration and overall drug exposure, with additional measures of drug clearance and half-life. The trial lasts until about 37 days after dosing, with ongoing safety monitoring.