Clinical Research Directory

Drug-drug Interactions Studies of VC005 Tablets in Healthy Adult Subjects

This study includes three groups of Drug-Drug Interaction( DDI ) studies: 1. To evaluate the effect of verapamil on the pharmacokinetics of a single oral dose of VC005 in healthy subjects; 2. To evaluate the effect of probenecid on the pharmacokinetics of a single oral dose of VC005 in healthy subjects; 3. To evaluate the effect of VC005 on the pharmacokinetics of a single oral dose of metformin tablets in healthy subjects.

A First-in-Human Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of HMB-003 in Healthy Volunteers

The purposes of this clinical study are 1. To see how the new drug (HMB-003) under study is tolerated in healthy volunteers, and if there are any important side effects. 2. To measure the amount of HMB-003 in the body after injection.

Safety, Tolerability and Pharmacokinetics of Oral Ketamir-2 in Healthy Adult Subjects

This is a prospective, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, and pharmacokinetics of oral Ketamir-2 in healthy adult participants. The study includes single ascending dose cohorts and multiple ascending dose cohorts.

Breathwork and Stress: Investigating the Mechanisms of Action and Effectiveness of Breathing Interventions in Modulating the Psychophysiological Response to Acute Stress Test

This study investigates whether the psychophysiological benefits of breathing exercises are driven by a specific physiological rhythm (6 breaths per minute) or by the general psychological experience of performing a structured, mindful activity. Researchers aim to determine if "coherent breathing", which is hypothesized to synchronize heart and respiratory rhythms, offers unique physiological protection against stress compared to breathing at a natural pace or simple resting. The main questions it aims to answer are: * Does slow, steady breathing at 6 breaths per minute lower physical stress markers (like heart rate variability and cortisol) better than faster, but structured breathing or just sitting still? * Is the calming effect caused by the specific breathing rhythm or simply by performing a structured, relaxing activity? Researchers will compare three groups to see if the specific rhythm of "coherent breathing" offers unique benefits: 1. Group (Interventional): Coherent Breathing: Slow breathing at 6 breaths per minute. 2. Group (Sham Breathing): Regular breathing at 15 breaths per minute (matching a natural pace). 3. Spontaneous Breathing (Control Group): Natural, unguided breathing. Participants will: * Complete a one-day preparation phase to become familiar with the breathing technique. * Visit the research center for one experimental session. * Perform their assigned breathing method before and after a stress test. * Take the Maastricht Acute Stress Test (MAST), which involves putting a hand in cold water and doing mental math. * Provide saliva samples and have their heart rate variability, and mood measured multiple times.

A SINGLE CENTER, 5-PART STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF GAL-101 SALT IN HEALTHY ADULT AND ELDERLY PARTICIPANTS

This first-in-human Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of GAL-101 salt following oral administration to healthy adult and elderly participants. A total of 92 participants were enrolled at a single study center. The study consisted of five parts. Part 1 evaluated single ascending doses of enteric-coated GAL-101 capsules compared with placebo in healthy adults. Part 2 compared a single dose of enteric-coated GAL-101 capsules with uncoated GAL-101 salt mixed with apple sauce in an open-label crossover design. Part 3 evaluated the effect of fasting, a standard meal, and a high-fat, high-calorie meal on the pharmacokinetics of a single dose of uncoated GAL-101 salt in an open-label crossover design. Part 4 evaluated multiple ascending doses of uncoated GAL-101 salt administered once daily for 7 days compared with placebo. Part 5 evaluated the pharmacokinetics of a single dose of uncoated GAL-101 salt compared with placebo in healthy elderly participants aged 65 to 85 years.

A First-in Human Study of ARD001 in Healthy Volunteers and People With Hemophilia A

This study is evaluating ARD001, an investigational medicine being developed for the treatment of hemophilia A. In Phase 1, healthy adult participants will receive a single dose of ARD001 or placebo to assess its safety and tolerability, how it moves through the body, its effects on blood coagulation, and whether the body develops antibodies against it. If the Phase 1 results support further study and the required regulatory and ethics approvals are obtained, Phase 2 will evaluate repeated doses of ARD001 in adults with hemophilia A. Phase 2 is not currently open for enrollment. The study is designed to determine whether ARD001 can be administered with acceptable safety and to identify doses suitable for further clinical development.

Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Chronic Study

The goal of this clinical trial is to learn how eating different snack foods affects long term hunger and gut health in healthy adults. The study will be conducted remotely over 7 weeks. The main questions it aims to answer are: 1. Does eating a snack bar intervention for 4-weeks change how hungry participants feel throughout the day compared to a control? 2. Does eating a snack bar intervention change gut microbiome, bowel habits, digestive symptoms, and other health measures compared to a control over 4 weeks? Researchers will compare an intervention snack bar to a control snack bar to see if the intervention improves hunger, gut microbiome, digestive symptoms and other health measures. Participants will: * Eat 2 snack bars in place of their usual snacks every day for 4 weeks * Complete health measurements at the start and end of the study: a health questionnaire, 3-day food diary, 3-day hunger \& satiety survey, body measurements, and a stool sample * Fill out a short online survey (under 5 minutes) once a week

Impact of Refractory Chronic Cough on Activities of Daily Living and Response to Acute High-intensity Exercise

Chronic cough is a common and debilitating condition that affects up to 10% of the global population. The health impact of chronic cough is multifaceted and manifests both physical and psychological symptoms including syncope, chest pain, lethargy, depression and anxiety. It is now also recognised that chronic cough often leads to social isolation and may impact an individual's ability or confidence to undertake routine daily tasks / lead an active lifestyle. The primary aim of this study is therefore to characterise the impact of refractory chronic cough on the ability to undertake daily activities - i.e., determine whether individuals with chronic cough exhibit impaired levels of physical activity during usual daily living when compared with healthy matched controls. A secondary aim is to assess the short-term impact of high-intensity exercise on cough (i.e., determine whether an acute bout of exercise alters cough frequency and/or severity).

Evaluation of Psychophysical Responses After Mechanical Stimulation.

This study evaluates the test-retest reliability of psychophysical responses to non-injurious sharp stimuli applied via a robotic system. The accurate assessment of acute mechanical pain, such as the pain associated with surgical incisions or non-suicidal self-injury, is challenging due to the subjectivity of pain and the risk of tissue damage with traditional mechanical stimulation methods. To overcome this barrier, researchers have developed a non-injurious sharp blade model that mimics the sensory characteristics of incisional pain without causing tissue damage. However, manual application of this blade introduces operator-dependent variability in force, speed, and duration. This study utilizes a novel robotic stimulator equipped with a non-injurious blade to deliver controlled stimuli. The experimental design involves healthy adult volunteers with two identical testing sessions separated by a minimum interval of 48 hours. During these sessions, participants undergo quantitative sensory testing (QST), including the evaluation of pain and tolerance thresholds using the robotic system on the ventral forearm. Additional measurements include pain threshold to pinprick stimulation, muscle stiffness, pain catastrophizing (Sullivan et al., 1995), and conditioned pain modulation. These results will establish the precision and reliability of this robotic system that are required for further clinical and experimental pain research.

Satiety, Microbiome, Appetite Regulation, and Tracking Energy Across Targeted Snacks: Acute Postprandial Study

The goal of this clinical trial is to learn how eating different snack foods affects acute hunger, energy intake and eating behaviour in healthy adults. The study will be conducted remotely over 5 days. The main questions it aims to answer are: 1. Does eating a snack bar intervention change how hungry participants feel later in the same day? 2. Does eating a snack bar intervention change participants' energy intake, nutrient intake and eating behaviour on the same day? 3. Does eating a snack bar intervention change participants mood, energy levels and alertness later in the same day? Researchers will compare an intervention snack bar to a control snack bar to see if the intervention improves hunger, energy intake, eating behaviour, and other subjective measures. Participants will: * Eat 2 snack bars for breakfast on 2 separate days, with 2 days in between * Not eat anything after 9pm the night before each test day * Fill out short online surveys (under 5 minutes) before breakfast and at set times over the next 3 hours * Not eat for 3 hours after breakfast * Write down everything they eat that day

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.

Stimulation Evaluation for Neuromodulation Sensory Effects

The goal of this clinical trial is to learn how healthy adults experience low-level electrical stimulation delivered through the study device. This study is not intended to treat a medical condition. The main questions it aims to answer are: Is the study stimulation comfortable and well tolerated? What sensations do participants notice during stimulation? Can participants tell the difference between active stimulation and sham stimulation? Researchers will compare active stimulation with sham stimulation. Sham stimulation uses the same study procedures but does not deliver the study stimulation. This comparison will help researchers understand whether sensations are caused by stimulation rather than the study setting or expectations. Participants will: Receive brief sessions of active and sham stimulation using the study device. Report sensations, discomfort, or other effects during and after each session. Complete questionnaires or other assessments about their experience with stimulation. The information from this study will help researchers select stimulation settings and procedures for future studies.

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.

Observational Study of Decentralized Urine Optical Interaction Patterns Associated With Environmental Microplastic and Nanoplastic Exposure

The goal of this observational study is to evaluate the feasibility and usability of at-home urine sample collection, preparation, and smartphone imaging using the EcoExposure™ platform in adults. The main questions it aims to answer are: Can participants successfully collect, prepare, and photograph urine samples at home and upload the images using a smartphone app? How consistent is image quality and participant adherence across repeated sampling over approximately 12 weeks? What is the short-term day-to-day variability in optical signals during an intensive daily sampling period? Participants will: Complete electronic consent and a brief intake questionnaire Collect and prepare urine samples at home at scheduled timepoints Capture guided smartphone photographs of the prepared samples Upload the images and provide brief feedback through the TrialKit app Optionally add a small reference solution (spike sample) to one sample for technical evaluation only The study is fully remote and lasts approximately 12 weeks. It is intended for product development and workflow validation purposes only and does not involve any diagnostic or clinical decision-making.

Global Reference Ranges - Mexico

The investigators aim to undertake the Global Reference Range Study (GRR) to establish a set of healthy adult reference values for measures of fibroinflammation, fat and size/volumes for the liver, and other abdominal and thoracic organs to assess, compare, and if necessary, propose ethnicity specific reference ranges for these measurements.

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.

Usability Evaluation of the Intelligent Fingerprinting Drug Screening System

This is a prospective performance evaluation of usability of the Intelligent Fingerprinting Drug Screening System, conducted in clinic. The total number of healthy adult subjects (male and female) required for enrollment in this study protocol is 45: 15 operators and 30 donors (ideally two donors assigned to one operator). The total duration of the study, from check-in through the end of the study will be 2-4 hours for each donor subject.

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.

Probiotic Research for Mental Health in Adult Volunteers

This randomized, double-blind, placebo-controlled pilot study will evaluate the effects of four weeks of supplementation with a probiotic on mental health in healthy adults aged 18-30 years. Participants will be randomized to receive either probiotic or placebo and will complete study assessments at baseline and end of intervention, and will complete a range of behavioral, physiological, and questionnaire-based assessments before and after the intervention. The primary objective is to assess the effect on emotional reactivity measured in a virtual reality scenario at the end of the intervention. This exploratory study is intended to generate data to inform future clinical research.

Safety, Tolerability, and Pharmacokinetic Evaluation of ADB116 for Injection

A Phase I Study of ADB116 for Injection in Healthy Chinese Adults. This study aims as follows: Primary Objective: • To evaluate the safety and tolerability of a single intravenous bolus dose of ADB116 for injection in healthy Chinese adults. Secondary Objective: • To evaluate the pharmacokinetic (PK) profile of a single intravenous bolus dose of ADB116 for injection.

DORA - A Study Using Digital Health Tools/Platform to Explore the Impact of the Consumption of Senior Milk Powder Containing Synbiotics on the Gut micRobiome in Healthy Aging Individuals

The DORA study is a single-arm, open-label, interventional exploratory study designed to evaluate the impact of a synbiotic-containing senior milk powder on the gut microbiome and selected biological, physiological, and digital health parameters in community-living adults in good health. The study enrolls adults aged 40 to 65 years and aims to investigate changes in gut microbial composition, with a primary focus on butyrate-producing microbial taxa, following at least 28 days of study product consumption. Secondary and exploratory objectives include assessment of stool metabolites, blood-based biomarkers, bowel patterns, sleep quality, physical activity, cognitive function, dietary patterns, and quality of life. Approximately 125 participants will be recruited in Singapore to achieve 100 study completers. Following informed consent and screening, participants undergo a baseline observation period of 14 days during which physiological and lifestyle data are collected using wearable digital health devices. Baseline assessments also include blood sampling, stool collection for microbiome analysis, digital imaging and videography, and completion of validated questionnaires. After completion of baseline assessments and collection of the first stool sample, participants initiate consumption of the study product, a senior milk powder containing a defined synbiotic formulation. The study product is consumed twice daily for a minimum of 28 days and up to 35 days to allow completion of study assessments. Participants return for end-of-intervention assessments following the study product phase, including repeat biological sampling, physical and digital assessments, and questionnaires. Stool microbiome profiles and other exploratory outcomes are compared between baseline and post-intervention time points. This exploratory study is intended to generate feasibility data and hypotheses regarding the effects of synbiotic nutritional intervention and the integration of biological and digital health data in the context of healthy aging.

Study on the Effect of Famotidine on Pharmacokinetics of Taletrectinib

This Phase 1 open-label trial aims to evaluate the effect of famotidine on the pharmacokinetics (PK), safety and tolerability of taletrectinib in healthy adult participants. To assess famotidine's impact on key PK parameters of taletrectinib and evaluate other PK parameters as well as safety endpoints. The study design: Part 1: Taletrectinib 600 mg administered under 2-hour fasting condition with three regimens: (Treatment A: Taletrectinib alone, Treatment B: Taletrectinib 2 h after single 40 mg famotidine. Treatment C: Taletrectinib dosed between two 20 mg famotidine doses). Part 2: Taletrectinib 400 mg administered with standard low-fat meal, followed by either Treatment B or C of famotidine co-administration.

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 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.