Clinical Research Directory

Bioequivalence of a Generic Azilsartan Medoxomil Tablet Compared With the Reference Product (Edarbi®) in Healthy Chinese Volunteers Under Fasting and Fed Conditions

This study compared a test azilsartan medoxomil potassium tablet (80 mg) with the reference product, Edarbi® (80 mg), in healthy adults. The study included a fasting part and a part in which participants took the study medication after a meal. In each part, participants were randomly assigned to receive both products, one at a time, in a different order. There was a 5-day washout period between doses. Blood samples were collected before and at scheduled times up to 48 hours after each dose to measure azilsartan levels. The researchers assessed whether the two products produced similar drug levels in the blood and monitored safety. The study was designed to evaluate bioequivalence, not to treat hypertension.

Development of an Improved Method of Measuring Total Body Bone Perfusion Using Total-body PET/CT

Broken bones (fractures) are a common problem in several serious health conditions, such as osteoporosis, kidney failure, and sickle cell disease. To better understand and treat these diseases, researchers need a reliable way to measure how much blood flows through our bones. In animal studies, a special scan called PET (Positron Emission Tomography) has been used successfully to measure bone blood flow. This scan uses a safe, low dose of a radioactive substance called sodium fluoride, which helps show how blood moves through the bones. However, using this method in people has been difficult in the past because older PET scanners were not sensitive enough to give accurate results. Recently, St Thomas' Hospital in London has received two new, state-of-the-art PET scanners. These scanners can take pictures of the whole body at once and are much more sensitive than older models. They can also take images of the heart during the scan, which is important because it allows researchers to measure how much of the radioactive tracer is being delivered to the bones through the bloodstream. This is a big improvement over older, more invasive methods that required taking many blood samples. The main goal of this pilot study is to develop a better, more reliable way to measure bone blood flow in healthy volunteers using these new PET scanners. The researchers also want to check if measuring the tracer in the heart is as good as, or better than, the previous method of taking frequent blood samples. To do this, the researchers will invite ten healthy volunteers-men and postmenopausal women over the age of 50-to take part in our study. Each volunteer will have a one-hour PET/CT scan, which takes images from the head down to the upper thighs after a small injection of the radioactive tracer. To compare the new method with the old one, the researchers will also take five small blood samples from the volunteer's arm at different times during the scan. The research team hope that this study will lead to better ways of studying and treating bone diseases in the future, making the process easier and less invasive for patients.

Study of ABS-201 Evaluating Single and Multiple Ascending Doses in Adults With and Without Androgenetic Alopecia

This is a first-in-human study of ABS-201, a new investigational medicine, in healthy adult men and women. Its main purpose is to find out whether ABS-201 is safe and well tolerated, as well as to understand how the body processes it and how it affects related biological markers. ABS-201 is being developed as a possible treatment for androgenetic alopecia (male- and female-pattern hair loss); its effect on hair growth has not yet been established. The study has two parts: in the single ascending dose (SAD) part, healthy adults receive one intravenous dose of ABS-201 or placebo; and in the multiple ascending dose (MAD) part, participants (including men with androgenetic alopecia) receive several subcutaneous doses of ABS-201 or placebo. The MAD part also evaluates the effect of ABS-201 on hair growth. The main questions it aims to answer are: What medical problems, if any, do participants experience when taking a single dose or many doses of ABS-201? How does the medication, ABS-201, compare to placebo (a look alike substance that does not contain any medication). Participants who qualify for the trial will receive either ABS-201 or a placebo, and visit the study clinic for scheduled checkups and tests for approximately 12 months in the single ascending dose (SAD) part and approximately 18 months in the multiple ascending dose (MAD) part. In the MAD part, participants receive repeated subcutaneous doses.

Acute Effects of a Single-Session Body Awareness Intervention on Cortical Activity and Interoceptive Accuracy

This study will examine the immediate (acute) effects of a single, 30-minute body awareness session on brain activity and interoceptive accuracy in healthy young adults aged 18-25. Participants will be randomly assigned to one of two groups: an intervention group, which will complete a structured body awareness exercise based on Basic Body Awareness Therapy, or a control group, which will rest quietly for the same amount of time without any specific instructions. Before and after the session, brain activity will be recorded using a portable, 8-channel EEG device, and interoceptive accuracy will be measured with a heartbeat perception task, in which participants try to count their own heartbeats without checking their pulse. The main goal is to determine whether a single body awareness session produces measurable changes in EEG brain wave patterns (theta, alpha, beta, and gamma bands) and in the accuracy of heartbeat perception, and whether these two types of change are related to each other.

TSPO Occupancy in the Human Lung

The investigators would like to explore the role of TSPO in PAH using a pharmacological challenge agent (XBD173) to modulate TSPO function. In order to appropriately design experimental medicine studies examining TSPO function, the investigators first need an understanding of the relationship between XBD173 dose and occupancy of lung TSPO. The aim of the proposed study, therefore, is to answer three questions: 1. What plasma concentrations of XBD173 are required to cause high occupancy of lung TSPO? 2. What doses of XBD173 are required to achieve these plasma concentrations at steady state? 3. Does taking XBD173 with food affect the plasma concentrations achieved? Part A will address question (1). In part A, the investigators will use positron emission tomography (PET) imaging with the TSPO targeting PET ligand \[11C\]PBR28 to quantify the amount of TSPO in the lung. The investigators will then administer XBD173 orally (between 10mg and 90mg), and perform two subsequent \[11C\]PBR28 PET scans. XBD173 and \[11C\]PBR28 both bind the same site on the TSPO, and therefore compete with each other for TSPO binding. This allows for quantification of TSPO occupancy by XBD173. Measuring XBD173 plasma concentrations during the PET scan will allow the investigators to learn how much XBD173 is required in the plasma to produce a certain degree of TSPO occupancy in the lung. Using a wide range of doses (10mg-90mg) and scan times ensures that some participants will have high TSPO occupancy and some will have low TSPO occupancy. This will allow the investigators to better understand the plasma concentration/occupancy relationship. Part B will address questions (2) and (3), i.e what doses of XBD173 are required to achieve the plasma concentration leading to high TSPO occupancy at steady state (to be determined in Part A), and does taking XBD173 with food affect the plasma concentrations achieved? The investigators assume that the plasma concentrations required to cause high TSPO occupancy (identified in Part A) will be achieved with a dose of approximately 60mg. Therefore, in Part B for study visits 1, 2 and 3, participants will receive 6 doses of 60mg XBD173 spread over 3 days and the effect of food investigated by dosing with and without food. In Part A at Study Visit 1, a \[11C\]-PBR28 PET scan will be performed under baseline conditions. XBD173 will then be administered (10-90mg, oral) on study visits 2 and 3 and two further PET scans will be performed post dosing to understand how long the drug blocks the binding of the PET tracer. The first two participants will be dosed with 10-90mg. The dose and scan times for remaining subjects will be based on occupancy and plasma drug level data for previous subjects. In Part B at Study Visit 1, participants will arrive fasted in the morning. After placement of a venous cannula will then be dosed with a single dose of oral XBD173 (60mg). Blood samples will be taken at up to 12 timepoints over 8 hours. At Study Visit 2, participants will arrive fasted in the morning. They will be given a standard breakfast and the procedures of Study Visit 1 will be repeated, with dosing occurring within 15 mins of finishing breakfast. They will receive a second dose of XBD173 (60mg) whilst at the ICRF 6-8 hours after the first dose, having had lunch. Participants will then be given a further dose to take at home that night prior to bed. At Study Visit 3, which will occur on the following day, participants will arrive in the morning fasted and will be given a standard breakfast. After placement of a venous cannula, they will be dosed orally with XBD173 (60mg) in the morning and again 6-8 hours later, and blood samples taken throughout the day. Study visits 4, 5 and 6 will be identical to Study visits 1,2 and 3 respectively, but for the dose of XBD173 which will be 40mg or 90mg depending on the plasma levels obtained with 60mg.

¹⁹F (Perfluoropropane) MRI

Healthy volunteers aged 18 to 85 will undergo ¹⁹F (perfluoropropane) MRI to support the development of imaging sequences, reconstruction algorithms, and hardware necessary for acquiring high-spatial resolution lung images. The study will also evaluate signal-to-noise ratio, contrast-to-noise ratio, spatial resolution, scan duration, and pulmonary gas exchange measurements derived from ¹⁹F (perfluoropropane) MRI.

A Study of ORN252 in Healthy Participants

The purpose of this study is to assess the safety and tolerability of ORN252 in healthy adult participants.

¹²⁹Xe(XENON) MRI Program

Healthy volunteers aged 18 to 85 will undergo hyperpolarized Xenon-129 (¹²⁹Xe) MRI and pulmonary function testing. The study aims to develop evaluation tools for ventilation defect percent (VDP), signal-to-noise and contrast-to-noise ratios (SNR/CNR) of ¹²⁹Xe dissolved-phase images, and spectroscopy-based analysis.

A Phase I Trial of Subcutaneous QLS7305 in Healthy Adults

The goal of this clinical trial is to evaluate the safety, tolerability, and preliminary characteristics of the investigational drug QLS7305 in healthy adult participants in China. The main questions it aims to answer are: What is the safety and tolerability profile of single and multiple subcutaneous doses of QLS7305 in healthy adults? What are the pharmacokinetic (PK) characteristics of QLS7305 and its major metabolites? What are the pharmacodynamic (PD) effects of QLS7305 on the complement system (e.g., serum C3 levels and complement activity)? Does QLS7305 induce an immunogenic response (anti-drug antibodies)? What is the effect of QLS7305 on the QTc interval? Investigators will compare different dose levels of QLS7305 to a placebo group to see the effects on safety, tolerability, and the measured parameters. Participants will: Be enrolled in one of two parts of the study: Part A (Single Ascending Dose): Receive a single dose of QLS7305 or placebo. Part B (Multiple Ascending Dose): Receive multiple doses of QLS7305 or placebo (doses selected based on Part A results). Receive prophylactic antibiotics (Penicillin V) after the first dose until their serum complement C3 level recovers, as a safety precaution. Undergo close safety monitoring throughout the study, including a follow-up period of up to 337 days to ensure safety parameters return to acceptable levels.

Resting-state Imaging and Chronic Consumption of Non-Nutritive SweetenerS

Non-nutritive sweeteners are used as a substitute for simple sugars to improve the palatability of food products without increasing their sugar and calorie content. They represent a global market of 7 billion euros, with an annual growth of 5%. Reducing their consumption therefore seems to be excluded. Some studies have focused on the impacts of these substances on brain activity. According to a recent study, continuous consumption of low doses of saccharin in adult mice significantly decreases the level of dopamine in the prefrontal cortex and significantly increases striatal dopamine, which modifies decision-making strategies. Resting-state functional Magnetic Resonance Imaging (r-fMRI) studies in humans have also shown that an increase in striatal dopaminergic activity modifies the resting-state functional connectivity of brain regions linked to the reward circuit. r-fMRI allows the characterization of brain networks and the strength of correlations between brain regions, without any specific task being required. It is a rapid, non-invasive technique that can measure changes in brain functional connectivity. In addition to r-fMRI, diffusion tensor imaging (DTI) is able to assess white matter microstructure and the integrity or otherwise of fiber tracts. Several parameters such as the fractional anisotropy (FA), coefficient of white matter, mean diffusivity, and radial diffusivity can be modified in the event of changes in functional connectivity, reflecting axonal rearrangements, not visible on conventional MRI sequences. Based on previous research, investigators hypothesize that (1) chronic consumption of non-nutritive artificial sweeteners increases striatal dopaminergic activity. (2) This modification is accompanied by changes in resting-state functional connectivity in brain regions of interest associated with the reward circuit in healthy young adults. Then, the primary objective of this study is to compare, in the resting state, the differences in functional connectivity of brain regions of interest between "non/low consumers" and "high consumers" of sweeteners at the start of the study using r-fMRI. The key secondary objective of this study is to assess changes in brain connectivity using r-fMRI in non- and low-consuming subjects before and after a transient increase in their sweetener consumption over 5 weeks. The secondary objectives include assessing daily sugar consumption (5-week follow-up), daily consumption of non-energy-rich artificial sweeteners (5-week follow-up), Body Mass Index (BMI), physical activity level, and white matter microstructure and fibrous tract integrity using a diffusion-weighted MRI (DTI) sequence.