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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the safety, tolerability, and levels of the study drug SYX-5219 in healthy volunteers and people with moderate to severe atopic dermatitis (AD). This multi-part, Phase 1, first-in-human study includes participants aged 18 to 65 years. The study aims to understand how SYX-5219 behaves in the body and to assess its safety in different dosing scenarios, including single and multiple doses as well as food effects. The study is divided into three parts. Part 1 involves single ascending doses (SAD) and a food effect evaluation in up to 48 healthy volunteers, who receive oral capsules of SYX-5219 or placebo. Part 2 tests multiple ascending doses (MAD) in up to 24 healthy volunteers with multiple oral doses given over a treatment period. Part 3 enrolls up to 45 participants with confirmed active AD to receive SYX-5219 or placebo daily for up to 42 days. This part is conducted at multiple global sites. Participants will undergo safety and exploratory efficacy assessments during treatment and follow-up periods. Researchers will monitor adverse events from the date of consent through various time points depending on the study part, including up to 10 days after dosing in Part 1 and up to 56 days in Part 3. Assessments include laboratory tests, vital signs, ECGs, and clinical evaluations to gather information on safety, tolerability, and drug levels in blood and urine throughout the study duration.
Actively Recruiting
Healthy Volunteer
Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of WVE-007, a stereopure siRNA oligonucleotide, in adults living with overweight or obesity. This Phase 1 study focuses on adults aged 18 to 60 years who have a body mass index (BMI) between 28 and 35 kg/m2, aiming to understand how the drug behaves and is tolerated when given in increasing single doses. Participants will receive ascending single subcutaneous doses of WVE-007 or placebo under a randomized, double-blind, placebo-controlled design. The study carefully monitors the effects of these doses to assess safety and how the body processes the drug. The treatment period includes administration of the drug and observation for any reactions or effects, with dose adjustments as planned. Throughout the study, participants will undergo medical history reviews, physical exams, and clinical lab tests to monitor health status and any adverse events from the first day through the end of the study. The main measurement is the proportion of participants experiencing adverse events. This study helps inform the safety profile and biological activity of WVE-007 in adults with overweight or obesity over the course of the trial.
Actively Recruiting
Healthy Volunteer
Stroke is a major cause of disability, with around 100,000 new cases each year in the UK. Most strokes, about 90%, can be prevented. Many strokes are linked to previous Transient Ischaemic Attacks (TIAs), which pose a high risk for stroke. This study focuses on finding new biomarkers that can better predict which TIA patients are most likely to have a stroke, aiming to improve prevention and care. The study plans to screen 300 patients who have experienced a TIA and follow them for 12 months to assess risks. Researchers will evaluate a novel biomarker involving endothelial derived extracellular vesicles, which are linked to increased blood clotting risk, and measure changes in prothrombin time, a blood clotting test. These measurements will be used to see if they help identify patients at highest risk of stroke. Participants will be monitored over three years to track changes in these biomarkers and clotting indicators. The study involves regular blood sampling and clinical assessments to gather data on stroke risk. Researchers will analyze how these biomarkers change over time and relate to stroke outcomes, helping to develop better prediction tools for stroke prevention.