Non-Smokers

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.

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, 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 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 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 Parkinson's 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 Parkinson's 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 Parkinson's 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 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.