Female

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 studying the safety, how the body processes, and the effects of the drug RO7875913 in healthy adult volunteers. This Phase I clinical trial aims to better understand the drug's behavior in the body and monitor any side effects or immune responses it may cause. The study is sponsored by Genentech, Inc. and focuses on healthy adults aged 18 to 65 years. Participants will be randomly assigned to receive either the study drug RO7875913 or a placebo. The study uses a dose-escalation design to evaluate different doses of RO7875913. The treatment period lasts up to approximately three months, during which various drug concentrations and immune responses are measured. The study also aims to identify the recommended dose for future studies. During the trial, participants will undergo safety monitoring with assessments for adverse events, blood tests to measure drug levels and immune markers, and evaluations of pharmacodynamic markers. The main outcome is tracking any adverse events up to about three months. Participants will be followed closely throughout the treatment and observation period, which includes laboratory testing up to Day 76. The total participation duration depends on the study schedule and dose escalation.

Researchers are evaluating the safety and tolerability of ABCL575, a biological agent, in healthy adult volunteers aged 18 to 65 years. This phase 1, randomized, double-blind, placebo-controlled study focuses on single ascending doses (SAD) of ABCL575 compared to placebo to understand how the body reacts to increasing doses and to monitor any side effects. The study is sponsored by AbCellera Biologics Inc. and involves healthy participants without significant health issues. Participants will be assigned randomly to one of five groups (cohorts A1 to A5) receiving escalating single doses of ABCL575 or placebo via subcutaneous injection. Each cohort includes eight healthy participants who receive either the study drug or a placebo injection. The dosing escalates from cohort A1 to A5 to gradually assess safety at higher doses. Throughout the study, participants will be monitored from day 0 up to day 337. Assessments include tracking adverse events, changes in laboratory tests (such as blood chemistry, lipids, coagulation, and urinalysis), vital signs, physical exams, ECGs, and injection site reactions. The study will also measure how ABCL575 is processed in the body, including blood levels over time and immune responses to the drug. Participants will undergo regular safety checks and evaluations during this period.

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 the binding of a new PET tracer called [68Ga]Ga-DOTA-Cys-ATH001 in the liver and gastrointestinal tract. The study compares healthy volunteers with patients who have metabolically caused steatohepatitis (MASH), fibrostenotic Crohn's 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 PET/MRI 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 participant's cohort and includes detailed assessments of tracer uptake and pharmacokinetics.

Researchers are evaluating a multilevel trauma-informed approach to increase HIV pre-exposure prophylaxis (PrEP) initiation among Black cisgender women in Baltimore, who are considered a high-risk group for HIV. This study aims to address socio-structural challenges such as intimate partner violence and gendered racism that may limit access to PrEP, focusing on both women with and without experiences of intimate partner violence. The research is sponsored by the Johns Hopkins Bloomberg School of Public Health and involves a randomized design without masking. Participants will be randomly assigned to one of two groups. The intervention group will receive behavioral lifestyle education related to biomedical HIV prevention, consisting of four weekly group sessions and four individual sessions with a peer navigator. The control group will receive a single group session. These sessions aim to increase understanding and uptake of PrEP among eligible Black women. During the study, researchers will monitor PrEP initiation up to six months after baseline and assess adherence at two, four, and six months post-randomization. Participant involvement includes attending scheduled educational sessions and follow-up assessments. The study will track how well participants start and continue PrEP use, with safety and sustainability of the intervention also evaluated. The total study duration extends through February 2028.

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 device's 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 device's performance. Total participation time depends on scheduling within the defined visit window.

Researchers are conducting a Phase 1, open-label study to evaluate how the drug YN001 behaves in the body, its safety, and immune response after a single dose in healthy adult volunteers. The study aims to refine the pharmacokinetic profile of YN001 to support its further clinical development. About 24 healthy male and female participants aged 18 to 65 will take part in this research. Participants will be divided into two groups, each receiving a single intravenous infusion of YN001 at either 20 mg or 40 mg. The study includes a maximum 27-day screening period, a baseline day before dosing, the treatment day when the drug is administered, and a follow-up period lasting up to 15 days. After assessments on Day 8, participants will have a final phone visit on Day 15. During the study, participants will undergo various health checks including vital signs, electrocardiograms, laboratory tests, and physical exams. Researchers will measure multiple pharmacokinetic parameters of YN001 such as maximum plasma concentration, time to reach maximum concentration, area under the concentration-time curve, half-life, clearance, and volume of distribution. Safety will be monitored by tracking adverse events and immune responses. Participants' involvement will last from screening through Day 15 post-dose.

Researchers are evaluating CLYM116, a humanized monoclonal antibody that targets a proliferation inducing ligand (APRIL), in healthy adult volunteers. This Phase 1, randomized, double-blind, placebo-controlled study aims to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of CLYM116. The study plans to enroll up to 48 participants across up to five groups. Participants will receive either subcutaneous injections of CLYM116 or a matching placebo. The study includes both single-ascending-dose and multiple-ascending-dose phases to understand how the drug behaves in the body and its effects over time. Treatments are administered under controlled conditions at a single study center. During the study, volunteers will undergo extensive monitoring including physical exams, ECGs, and laboratory tests. Researchers will track adverse events, injection site reactions, drug concentrations in plasma, immunoglobulin levels, and the presence of anti-drug antibodies. These assessments will occur from screening through to approximately 85 days after dosing, with follow-up visits to ensure safety and collect data on the drug's effects.