Clinical Research Directory

Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study of ALXN2230 in Healthy Participants

The primary objective of this study is to evaluate the safety and tolerability of single subcutaneous (SC) doses of ALXN2230 in healthy participants.

Effect of Magnesium Supplementation on Sleep Quality and Cognitive Function in Saudi Adults

The goal of this clinical trial was to evaluate whether magnesium citrate supplementation improved sleep quality and cognitive function in healthy Saudi adults. It also assessed the effects of magnesium on selected blood markers. The main questions it aimed to answer were: Did magnesium supplementation improve sleep quality? Did magnesium supplementation improve cognitive function? Researchers compared participants who received magnesium citrate to a control group that did not receive any intervention to evaluate its effects. Participants: Took magnesium citrate (400 mg daily) for 90 days (two capsules: one in the afternoon and one 1-2 hours before bedtime) Visited Umm Al-Qura University twice (before and after the intervention) for: Sleep quality assessment Cognitive function assessment Blood sample collection to measure serum magnesium and HbA1c The control group did not receive any supplementation during the study period.

A Study to Evaluate the Bioequivalence of DA-5230 Compared to DA-5230-R

A study to evaluate the bioequivalence of DA-5230 compared to DA-5230-R

Safety and Efficacy of a Prebiotic Blend in Healthy Humans

The GRASP Trial is a 30-day, randomized, double-blind, placebo-controlled study (Protocol No.: GW-2025-02) designed to evaluate the safety and tolerability of a novel multi-fiber prebiotic blend in healthy adult volunteers (age 18-60, normal BMI). Participants will be randomized (1:1:1) to receive either a low dose (1 dose/day), a high dose (2 doses/day), or an identical placebo powder for 30 days. The primary objective is to evaluate safety and tolerability, measured by the incidence and severity of gastrointestinal adverse events (AEs) and discontinuations. Secondary objectives include assessing the fiber blend's impact on gastrointestinal symptoms (measured by the Gastrointestinal Symptom Rating Scale or GSRS score), beneficial gut microbiome composition (specifically SCFA-producing bacteria like Bifidobacterium spp.), and gut barrier function/inflammation (via markers like LBP, zonulin, hs-CRP, and IL-6). Exploratory objectives will examine effects on sleep and activity patterns using a wearable tracker, as well as quality of life (SF-36) and stress (PSS). The trial includes assessments at baseline (Day 0) and end-of-treatment (Day 28 ± 2), including the collection of blood, urine, and stool samples for comprehensive analysis.

Evaluation of [18F]GATT-44 for Positron Emission Tomography Imaging of the GABA Transporter-1

Evaluate \[18F\]GATT-44 (aka \[18F\]GAT44), to characterize its pharmacokinetic, metabolic, and in vivo binding profile, and assess the reproducibility of kinetic and binding parameters. Assess specific binding levels of \[18F\]GATT-44 by conducting a test-block study in humans. Estimate human dosimetry of \[18F\]GATT-44 by performing whole-body imaging studies.

Kimchi and Gut Health

The goal of this study is to learn about the effects of eating kimchi on the gut health of healthy adults in the USA. The investigators will be researching the changes in the gut microbiome, biomarkers of gut health and cardiometabolic health after consuming fermented and unfermented cabbage. The main questions it aims to answer are: Does eating kimchi (fermented cabbage) result in enrichment of lactic acid bacteria in the stools of participants? Does eating kimchi result in metabolic changes in the gut microbiome, biomarkers of gut and cardiometabolic health of participants? Researchers will compare a group of participants eating fermented cabbage (kimchi) daily to a group of participants eating non-fermented cabbage daily. Participants will: Eat kimchi or cabbage daily for 3 weeks. Visit the study site for brief visits up to 5 times. Have blood drawn and provide a fecal sample 2 times - at beginning and end of the 3 week study. Keep occasional records of food intake and questionnaires about any gastrointestinal symptoms that participants may have.

Location- and Frequency-Dependent Effects of Thalamic Temporal Interference Stimulation During Sleep

This study is to find out whether a type of non-invasive electrical brain stimulation called temporal interference transcranial electrical stimulation (TI-TES) can temporarily change brain activity during sleep, especially sleep spindles (brain rhythms in the \~8-16 Hz range). Up to 24 healthy participants in Dane County, Wisconsin will be enrolled for 3 overnight study visits. Participants can expect to be on study for approximately 5 weeks, depending on scheduling availability.

RIG 101 Trial in Healthy Adults and Adults With Asthma

Nested Phase 1-2 Trial of RIG-101 in Healthy and Asthmatic Participants Assessing Safety, Tolerability and Viral Challenge Efficacy

A Clinical Trial to Test the Safety, Tolerability, and How the Body Processes CPV-104 in Healthy People and Patients With C3-Glomerulopathy

This study is the first time the new medicine CPV-104 is being tested in people. CPV-104 is designed to regulate the complement system, which can be overactive in diseases such as C3 glomerulopathy (C3G), an ultra-rare kidney disorder. The study includes healthy adults and adult patients with C3G to assess safety, tolerability, how the body processes the medicine, and whether the immune system reacts to it. The study is divided in two part; in Part 1 (SAD), healthy volunteers receive one IV dose of CPV-104 or a placebo while in Part 2 (MAD) patients with C3G receive four weekly IV doses of CPV-104 (no placebo). Participants will have close monitoring, including side-effect checks, blood and urine tests, ECGs, vital signs, and blood samples to measure drug levels and antibodies. For those with C3G, researchers will also observe kidney function, although the main goal is safety, not testing effectiveness. A Safety Review Committee will regularly review results to ensure it is safe to continue to the next dose or study group.

A Study to Learn if Itraconazole Changes How the Body Processes PF-07248144 (Study Medicine)

The purpose of the study is to learn how itraconazole changes how the body processes the study medicine called PF-07248144. The study will also look at the safety, tolerability, and how PF-07248144 is changed and removed from the body after taking PF-07248144 alone compared to when it is taken with itraconazole. Itraconazole can change how your body processes some medications so it may change the body's processing of PF-07248144. Multiple blood samples will be collected after each dose of PF-07248144 to determine how much PF-07248144 is in the blood at different times. This will help characterize the pharmacokinetics (pharmacokinetics helps us understand how the drug is changed and eliminated from your body after you take it) of PF-07248144 alone and when taken with itraconazole.

Turkish Validity and Reliability Study of PRevention of Toxic Chemicals in the Environment for Children Tool

The aim of this study is to conduct a Turkish validity and reliability study of the "Prevention of Toxic Chemicals in the Environment for Children Tool," developed to examine the knowledge and attitudes of parents and prospective parents regarding the effects of toxic chemicals in the environment on children's development.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

This study is the first-in-human (FIH) study of BGB-45035. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BGB-45035 with both a single dose and multiple doses administered at different dose levels in healthy participants, followed by a Part E to evaluate the safety and tolerability of BGB-45035 in adults with autoimmune dermatological diseases like atopic dermatitis (AD) and prurigo nodularis (PN). An additional biomarker cohort will be evaluated in Part F. Study details include: * The study duration will be up to 24 months. * The treatment duration will be up to 14 days for Parts A-D, up to 12 weeks for Part E, and up to 3 weeks for Part F. * Safety follow-up 30 days after last dose of study drug.

Validation of Different Methods for HepQuant DuO® Blood Sample Collection

This is a study to see the agreement of blood samples collected through different means and tube types for the HepQuant DuO Test. The HepQuant DuO Test is a blood-based test that involves a drink of a natural compound, cholate, and blood samples at 20 and 60 minutes. The study team is collecting clinical and laboratory data from patients living with chronic liver disease and healthy adult volunteers. The study has up to 2 study visits at an outpatient clinic and can take up to 4 weeks for a participant to complete study. At these visits, participants will undergo a HepQuant DuO test and other standard lab tests. In addition, the study team will ask about a participant's experience with different blood sampling methods.

Evaluation of MTX-439 in Healthy Adults and Adults With Diabetic Kidney Disease

This is a phase 1 randomized, double-blind, single ascending dose (SAD) and multiple ascending dose (MAD) study to assess the safety, tolerability, and Pharmacokinetics (PK) of single and multiple ascending doses of MTX-439 administered in healthy adults and adults with diabetic kidney disease (DKD)

Effect of Low-Carbohydrate Versus Balanced Diets on Anthropometric Blood Pressure, ApoB, and hsCRP in Healthy Adults

The goal of this clinical trial is to explore the effect of a low-carbohydrate diet and a balanced diet. The main questions it aims to answer are: * Does a 4-week diet intervention improve anthropometric and cardiovascular parameters? * What diet is more effective in promoting weight loss and improving cardiovascular parameters? Researchers will compare a low-carbohydrate diet and a balanced diet with control group. Participants will: * Take the intervention diet or control diet for 4 weeks * will submit food records three times a week * Visit the study location 2 times for check up and test

A Study to Evaluate EDG-7500 in Caucasian and Japanese Adults

The purpose of this Phase 1 study is to understand and compare the amount of EDG-7500 in the blood after single and multiple doses in Japanese and Caucasian adults. The safety of EDG-7500 in these adult participants will also be evaluated in this study.

Fluoxetine and Understanding Social Experiences

Adolescence is a critical developmental period marked by significant social, cognitive, and emotional changes. Unfortunately, it is also a time when the risk of depression and anxiety rises dramatically. Early, effective treatment is essential to mitigate long-term impacts on relationships, education, and life satisfaction. While psychological therapies are recommended as first-line treatment for mild to moderate depression in young people, antidepressant use (particularly SSRIs such as Prozac) has risen sharply, especially among girls aged 15-17. Despite their widespread use, there is limited research on how SSRIs address adolescent depression, leaving clinicians with little evidence to guide treatment decisions. The Fluoxetine and Understanding Social Experiences (FUSE) study aims to shed light on how Prozac (medically known as fluoxetine) influences decision-making in healthy young people in four key areas that are known to be affected by depression: emotional processing (e.g., facial expression recognition), social function (e.g., sensitivity to peer rejection), reward processing (e.g., how people learn from rewards and punishments), and motivation (e.g., how people make decisions about whether a certain outcome or reward is worth the effort to obtain). Some of the tests employed in the study use facial expression and heart-rate recording as aditional measures. We are aiming to recruit and test 80 young people between the ages of 18 and 24. When included in the study, participants are randomly assigned to receive either a weeklong treatment with fluoxetine, or a placebo (a pill with no active ingredients). The study follows a double-blind design, which means that neither the researchers nor the participants are aware of the treatment received so as to not influence the results. We belive that fluoxetine will have beneficial effects on social decision-making in young people, which might manifest as increased accuracy labelling positive facial expressions, less sensitivity to negative feedback, lower self-reported negative mood in response to social exclusion and reduced heart rate/negative facial expressivity in response to unpleasant social experiences. The FUSE study aims to deepen our understanding of how antidepressants affect decision-making in young people, at a time when antidepressant prescriptions have risen but research is scarce. By identifying the exact domains of functioning which are affected by antidepressant use in this age group, this research will help inform which young people are likely to benefit most from drug treatment. The project results will be published in peer-reviewed journals and presented at academic conferences. We are also working with a group of young advisors who will help us decide how to best share our results with others in their age group. A brief summary of the study findings will also be provided to participants who would like to receive it. All research data, excluding information that could identify participants, will be stored safely for at least 10 years after final publication or public release.

Phase 1 Study of ADX-626 in Healthy Participants

This first-in-human study will evaluate the safety and tolerability of ADX-626 in healthy participants. The study will also look at how ADX-626 interacts with the human body (the pharmacokinetics and pharmacodynamics of ADX-626).

Muévete conCiencia: Exercise and Mind-Body Program for First-Year University Students

The goal of this clinical trial is to evaluate whether different physical exercise and mind-body interventions can improve executive functions and reduce stress in first-year university students. The study focuses on healthy undergraduate students, men and women, aged approximately 18-25 years, enrolled in the first year of health-related programs at a Chilean university. The main questions it aims to answer are: Do high-intensity dual-task physical exercise interventions improve executive functions (working memory, inhibitory control, and cognitive flexibility) and reduce stress in university students? Do mind-body exercise interventions (Tai Chi) reduce stress levels, measured through self-report and psychobiological biomarkers (cortisol)? Are there differential effects between high-intensity dual-task exercise, low-to-moderate intensity mind-body exercise, and cognitive stimulation on executive functioning and stress-related outcomes? Researchers will compare: * high-intensity dual-task exercise group, * low-to-moderate intensity mind-body exercise group (Tai Chi), and * cognitive stimulation control group, To determine whether physically integrated motor-cognitive training produces greater improvements in executive functions and stress biomarkers than mind-body exercise or cognitive stimulation alone. Participants will: Complete baseline pre-intervention and post-intervention assessments, Neuropsychological tests of executive functions (working memory, inhibitory control, cognitive flexibility), Self-reported academic stress questionnaires, Psychobiological measures of stress (hair cortisol, salivary cortisol), Physical activity, anthropometric, and sociodemographic assessments. Participate for 12 weeks (22 sessions, twice per week) in one of the following interventions: High-intensity dual-task physical exercise, combining aerobic, strength, and motor-cognitive tasks; Low-to-moderate intensity mind-body exercise (Tai Chi) emphasizing mindful movement, balance, breathing, and attentional control; Cognitive stimulation sessions using a structured digital cognitive training program. All sessions will be conducted in supervised, controlled settings by trained professionals, following standardized protocols to ensure safety, consistency, and adherence.

Sedentary Behaviour, Physical Activity Patterns, and Cardiometabolic Health

According to the World Health Organization (WHO), chronic diseases are a major global public health concern and the leading cause of mortality worldwide. In the absence of evidence-based actions, the global annual deaths from chronic diseases are projected to rise to 55 million deaths in 2030, accompanied by a substantial increase in socio-economic costs. In this context, the WHO identifies type 2 diabetes mellitus (T2DM) and cardiovascular diseases (CVD) as key chronic conditions of concern related to cardiometabolic health. Both sedentary behaviour (SB) and physical inactivity have been recognised as interdependent risk factors for the development of T2DM and CVD. SB refers to any waking behaviour, characterised by a low energy expenditure, while being in a sitting or reclining posture, whereas physical inactivity denotes insufficient levels (\<150 min per week,) of moderate-to-vigorous physical activity (MVPA). Studies using objective measures have demonstrated that on average Western adults spend 8-12h in SB per day, of which the majority is spent in prolonged sedentary bouts (lasting ≥30 min). In addition, up to 30% of adults worldwide are physically inactive, with higher levels of inactivity in high-income countries. Within this context, it has become evident that excessive prolonged SB, often in combination with physical inactivity, negatively impacts cardiometabolic health, contributing to insulin resistance, increased adiposity, poor lipid profiles and endothelial dysfunction. Given their detrimental effects on T2DM and CVD, strategies aimed at reducing SB and promoting physical activity (PA) warrant further investigation. Reducing and regularly interrupting SB, even with low-intensity PA, alongside sufficient MVPA, is crucial for maintaining a healthy cardiometabolic profile. Reflecting this, the WHO guidelines advise individuals to engage in 150-300 minutes of moderate-intensity physical activity, 75-150 minutes of vigorous-intensity physical activity, or an equivalent combination each week. Notably, the 2020 WHO guidelines also included recommendations on SB for the first time, emphasizing the importance of limiting sedentary time. The WHO states that replacing SB with physical activity of any intensity can yield health benefits. However, these recommendations remain non-prescriptive and somewhat vague, primarily due to a lack of robust scientific evidence on the optimal frequency, intensity, and duration of PA needed to interrupt sedentary time. The absence of specific guidelines on prolonged SB reflects this evidence gap. To support policy development, well-designed randomised controlled trials are needed to evaluate effective and practical strategies for reducing sedentary time. So far, the short term cardiometabolic health effects of SB interruptions have been investigated by our research group, laboratory studies of collaborators and other international researchers, demonstrating that; 1) more frequent SB interruptions especially affect glucose metabolism and insulin sensitivity; 2) higher intensity interruptions are associated with cardioprotective adaptations and; 3) longer durations of SB interruptions positively affect lipid metabolism. However, because under real-world conditions frequency, intensity and duration of SB interruptions usually interact, their combined effects on cardiometabolic health need further investigation. Many studies already compared the isolated effects of different SB interruption patterns with respect to frequency, duration and intensity on cardiometabolic health. However, the combined effects of these different approaches matched for energy expenditure are not clear yet. We therefore perform a balanced cross-over study in which the efficacy of distinct activity patterns on cardiometabolic health insulin sensitivity and vascular function) will be compared to a sedentary control condition.

Ginkgo Active App-Based Exercise Training

The purpose of this study is to investigate the effectiveness and usability of a Gingko app based exercise training in middle and older aged adults. The main question it aims to answer is if the personalized Gingko app-based exercise is more effective in improving overall physical function than self-guided training with the NIA exercise booklet.

Acute Effects of Alpha-glycerylphosphorylcholine (A-GPC) on Lower Body Muscular Performance.

The purpose of the present study was to examine the effectiveness of acute A-GPC supplementation on upper and lower body muscular strength, endurance, power, and global levels of activation.

Pharmacokinetic Characterization of Tartaric Acid in Humans

The goal of this clinical trial is to characterize the pharmacokinetics (absorption, distribution, metabolism, and excretion; ADME) and oral bioavailability of tartaric acid in humans after its administration through different food matrices (red wine, fresh grapes, and grape juice). The study aims to determine whether the pharmacokinetic behavior of tartaric acid is matrix-dependent and dose-dependent in healthy adult volunteers. The main questions it aims to answer are: Does the food matrix (wine, grapes, or grape juice) influence the oral bioavailability of tartaric acid? Are there differences in key pharmacokinetic parameters of tartaric acid, including maximum plasma concentration (Cmax), time to reach maximum concentration (Tmax), total exposure (AUC), half-life (t1/2), and urinary excretion, depending on the matrix of intake? Researchers will compare the pharmacokinetic profiles of tartaric acid after consumption in red wine, grapes, and grape juice to evaluate differences in absorption, systemic exposure, and elimination attributable to the source of intake. Participants will: Follow a polyphenol-restricted diet prior to the study, including avoidance of grapes, wine, and related products. Consume a single standardized dose of tartaric acid administered as red wine, fresh grapes, or grape juice after an overnight fast. Provide blood samples at multiple time points over a 24-hour period to determine plasma tartaric acid concentrations. Collect urine samples over 24 hours for assessment of tartaric acid excretion. Consume standardized low-polyphenol meals under controlled conditions during the study day.

A Usability Study of a Multi-channel ECG Monitoring Device

This study it to evaluate the usability of the WearLinq eWave patch in a general adult population.