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Researchers are developing advanced four-dimensional magnetic resonance imaging 4D-MRI techniques to create detailed, moving images of the lungs and liver in adults. This imaging method produces three-dimensional movies that capture organ motion during breathing, which is important for improving radiation therapy planning for lung and liver cancer patients. The study aims to overcome challenges in current imaging methods to better target tumors that move with respiration. The study includes two main parts technical development of ultra-quality 4D-MRI in healthy volunteers and evaluation of the technique in cancer patients. This involves creating a new MRI pulse sequence and image reconstruction process to achieve high spatial and temporal resolution with minimal motion artifacts. Researchers will compare the new 4D-MRI method to existing imaging and registration techniques in both healthy volunteers and patients with lung or liver tumors undergoing radiation therapy. Participants will undergo a single imaging session lasting up to two hours involving 4D-MRI scans. Healthy volunteers and cancer patients will be assessed to measure image quality and accuracy of motion modeling. The study will monitor how well the 4D-MRI technique captures tumor movement compared to current methods. The total participation time is limited to the imaging session, with no long-term follow-up mentioned.

Researchers are evaluating how well MSP-2020, a study drug, attaches to serotonin type 2A receptors in the brain of healthy male adults. This Phase 1 study aims to understand the drugs presence in the blood, how long it stays, and its safety profile. The study is conducted by Otsuka Pharmaceutical Development & Commercialization, Inc. and focuses on healthy volunteers aged 23 to 55 years. Participants will receive a single oral dose of MSP-2020 on Day 1. The study uses positron emission tomography PET scans to measure receptor occupancy and drug binding. Blood samples will be collected up to Day 2 to analyze the drugs concentration, peak levels, half-life, and metabolite presence. Safety will be monitored through assessments including vital signs, ECG, laboratory tests, and neurological exams. During the study, participants will stay in a clinical research unit for up to 4 days for observation and assessments. Researchers will monitor adverse events and changes in health status up to Day 15. The primary outcomes focus on drug binding in the brain and pharmacokinetics, while secondary outcomes include safety measures and changes in relevant clinical scales. The total participation time includes dosing, imaging, blood sampling, and safety follow-up.

Researchers are evaluating the safety and effectiveness of Flonoltinib Maleate Tablets in adults with intermediate- or high-risk myelofibrosis, a type of bone marrow disorder. This Phase III clinical trial compares Flonoltinib with the active control drug Ruxolitinib Phosphate. Participants are assigned to one of the two groups based on their risk level using the Dynamic International Prognostic Scoring System DIPSS. The study aims to measure how well these treatments reduce spleen size and improve symptoms over time. Participants take either Flonoltinib 75mg once daily or Ruxolitinib according to prescribed doses twice daily, both taken on an empty stomach. The trial is open-label and conducted at multiple centers, with approximately 105 participants planned for enrollment. Treatment continues until withdrawal criteria are met. The study includes evaluations at various time points up to 24 weeks, focusing on spleen volume reduction and symptom improvement. During the trial, participants undergo regular assessments including physical exams, spleen size measurements using MRI or CT scans, and symptom scoring using the MPN-SAF Total Symptom Score. Blood tests monitor organ function and safety. The primary outcome is the percentage of subjects achieving at least a 35% reduction in spleen volume at week 24. Secondary outcomes include time to spleen response, symptom score changes, and overall survival. Safety and laboratory tests are conducted throughout the study, which lasts several months from enrollment to final assessments.

Researchers are evaluating flonoltinib maleate tablets in adult patients with intermediate to high-risk myelofibrosis MF who are refractory, relapsed, or intolerant to JAK inhibitors. This single-arm, open-label, multicenter phase IIb clinical trial aims to assess the safety and efficacy of this treatment in patients who have limited options after prior JAK inhibitor therapy. Participants will receive flonoltinib maleate tablets orally once daily on an empty stomach. The dose, either 50mg or 75mg, is assigned based on platelet counts measured during the screening period. Treatment continues until participants meet withdrawal criteria. The study includes approximately 64 participants and focuses on those with splenomegaly and specific blood count and organ function criteria. During the study, participants will be monitored regularly for spleen volume reduction, symptom improvement using the MPN-SAF TSS score, and overall survival over 24 weeks. Safety and organ function tests, including blood counts and liver and kidney function, will be performed. Researchers will track treatment effects and side effects throughout the trial duration, with all assessments planned at various time points including weeks 2, 4, 8, 12, and 24.

This trial evaluates the safety, pharmacokinetics, and pharmacodynamics of the drug RO7875913 in healthy adult volunteers aged 18 to 65 years. The study is designed as a Phase I dose-escalation trial to understand how the drug behaves in the body and its potential effects, involving both RO7875913 and placebo treatments. Participants are healthy individuals without major medical conditions, providing a controlled setting to assess the investigational drug. Participants are randomly assigned to receive either RO7875913 or a placebo in a sequential dose-escalation manner. The study uses quadruple masking to ensure unbiased assessment. Dosage and administration schedules follow the protocol, with detailed monitoring of drug concentration and immune response markers during treatment. This study includes a period of up to approximately three months for safety and pharmacodynamic evaluations. Throughout the trial, participants undergo assessments including monitoring for adverse events, blood tests to measure drug levels and antibody responses, and pharmacodynamic marker evaluations. Researchers closely track safety outcomes and determine recommended doses for future studies. Participation involves regular visits for dosing and evaluations, lasting up to three months in total, ensuring careful observation of participants health and response to the study drug.

Researchers are studying MT-251, a new biologic drug, in healthy adults aged 19 to 55 to evaluate its safety, tolerability, how the body processes it, and its immune response. This Phase 1, randomized, double-blind, placebo-controlled trial aims to gather important information to guide further development of MT-251. Participants will receive either single or multiple doses of MT-251 given by intravenous or subcutaneous injection. The study has two parts one to assess single ascending doses and another to assess multiple ascending doses, both closely monitored to evaluate safety and tolerability. During the study, participants will be monitored for side effects up to 14 days after dosing. Researchers will conduct health assessments and collect data to understand how MT-251 behaves in the body and its impact on the immune system. The study involves healthy volunteers and includes careful follow-up to ensure participant safety and gather necessary pharmacokinetic and immunogenicity information.

Researchers are studying PRD001 to assess its safety, tolerability, and how it behaves in the body pharmacokinetics in healthy men and men with mild high LDL cholesterol and mild fatty liver. This Phase 1 trial aims to better understand how PRD001 works in different groups, including healthy volunteers and those with borderline to mild lipid and liver conditions. The study is sponsored by PRD Therapeutics, Inc. and includes men aged 18 to 60 years. The trial is randomized and quadruple-masked to ensure unbiased results. Participants will receive oral capsules of PRD001 or placebo. The study has multiple parts Part 1A involves single ascending doses, Part 1B looks at dietary effects after Part 1A, Part 2A includes 14 days of multiple ascending doses, and Part 2B includes 28 days of multiple ascending doses in men with mild hyper-LDL-cholesterolemia and mild fatty liver. Each part follows specific schedules of dosing and assessments to monitor effects. During the study, participants will undergo various assessments including vital signs, physical examinations, electrocardiograms, and laboratory tests. Researchers will track treatment-emergent adverse events and serious adverse events over 42 days, covering 28 days of treatment and 14 days of observation. Participants must comply with scheduled visits, treatment plans, and tests throughout the study period, which extends until 2026. Safety and tolerability are closely monitored to understand the impact of PRD001.

Researchers are evaluating JAB-8263, a small-molecule inhibitor targeting BET proteins, in adult patients with advanced malignant solid and hematologic tumors in this Phase 12a open-label study. The study aims to find the highest safe dose, assess dose-limiting toxicities, evaluate safety and tolerability, and gather early evidence of antitumor activity in patients whose tumors have progressed despite standard treatments or lack standard options. The study has two parts dose escalation and dose expansion, each enrolling about 30 subjects. Participants receive JAB-8263 orally every two days in 28-day cycles, with dose adjustments to determine the recommended Phase 2 dose. The study monitors how the drug behaves in the body and its preliminary effects on tumors. Participants will undergo evaluations over approximately 18 months, including safety assessments, pharmacokinetic measurements, and tumor response evaluations using standardized criteria. Researchers will record adverse events, response rates, and survival outcomes while monitoring dose-related toxicities. The study does not use randomization or masking, and participants are closely followed to assess treatment effects and safety.

Researchers are evaluating the binding of a new PET tracer called 68GaGa-DOTA-Cys-ATH001 in the liver and gastrointestinal tract. The study compares healthy volunteers with patients who have metabolically caused steatohepatitis MASH, fibrostenotic Crohns Disease CD, and primary sclerosing cholangitis PSC. This first-in-human, phase 0, multi-center trial aims to understand tracer uptake patterns and assess its safety and distribution in the body. Participants receive a single intravenous injection of up to 100 micrograms of the tracer, followed by PET and MRI scans to visualize tracer binding and body function. Some participants in specific cohorts undergo a second injection and imaging visit within six weeks to test tracer reliability. Blood samples are collected from certain groups to measure tracer levels over time. Safety assessments and remote follow-up calls are also part of the study protocol. During the study, participants will have health checks and eligibility screening before dosing. Imaging includes whole-body PETMRI scans and specific examinations like FibroScan for some groups. Safety is monitored through vital signs, ECG, lab tests, and injection site observations. Follow-up calls check on any side effects or medication use. The trial involves 2 to 3 visits depending on the participants cohort and includes detailed assessments of tracer uptake and pharmacokinetics.

Researchers are evaluating a new generation of magnetoencephalography MEG devices that use optically pumped magnetometers with Helium 4 to record brain magnetic activities. The study includes healthy adults and male athletes who have suffered a mild concussion. The goal is to compare this new devices ability to detect and map brain activity with that of classical MEG systems, focusing on brain responses to visual, auditory, somatosensory, and motor stimuli. Participants will undergo several experiments using the FYNA Research MEG system. Healthy volunteers will complete tasks involving visual and auditory attention, language production, rest, and visuo-motor activities. Concussed athletes will have their resting brain activity recorded to assess frequency modulations. The study compares signal-to-noise ratios and brain activity maps from the new device with those from classical MEG during these tasks. During the study, participants will visit once for inclusion and then return within 1 to 30 days for MEG recordings and assessments. Researchers will measure signal quality, brain activity mapping, and participant comfort through questionnaires after recording sessions. The study monitors safety and participant experience, aiming to gather detailed data on the new MEG devices performance. Total participation time depends on scheduling within the defined visit window.