Clinical Research Directory

Investigating Sex Differences in Mitochondrial Function and Leg Blood Flow During Exercise

This study will compare mitochondrial function and leg blood flow during exercise in healthy endurance-trained females and males aged 19-35.

Tegoprazan-Aspirin Drug Interaction in Healthy Adult Male Volunteers

This Clinical Trial Aims to Evaluate the PK/PD Drug-Drug Interaction and Safety/Tolerability of Tegoprazan and Aspirin in Healthy Adult Male Volunteers.

Comparative Study of EnliTuo® Before and After Technology Change in Healthy Male Volunteers

This study is a randomized, double-Blind, parallel-controlled, single-dose pharmacokinetic, safety, and immunogenicity comparative study of EnliTuo® before and after technology change in healthy male volunteers.

Effects of Caffeine on Agility in Amateur Soccer Players

This randomized, double-blind, placebo-controlled crossover clinical trial aims to investigate the acute effects of caffeine supplementation on motor and perceptual-cognitive components of agility performance in male amateur soccer players. The main questions are: i) Does acute caffeine supplementation improve motor performance, including countermovement jump height, drop-jump reactive strength, and planned agility? ii) Does acute caffeine supplementation improve perceptual-cognitive performance during reactive agility tasks involving light and human stimuli? Participants will complete two experimental conditions in randomized order, receiving either 300 mg of caffeine (\~3.7 miligrams/kilograms of body mass) or placebo pills. Following ingestion, participants will perform countermovement and drop jumps and three Y-shaped agility tests assessing planned agility, reactive agility to a light stimulus, and reactive agility to a human stimulus.

Single-ascending Dose Study of HEC-151 Injection

Evaluate the safety, tolerability, PK/PD and immunogenicity characteristics of a single subcutaneous HEC-151 Injection solution in healthy participants

Efficacy and Safety of Two Hair Supplements in Men With Androgenic Alopecia

The goal of this clinical trial is to evaluate the efficacy and safety of two different formulations of a food supplement on hair health in healthy Caucasian male subjects aged 35 to 65 years with mild to moderate androgenetic alopecia. The main questions it aims to answer are: * Whether the two formulations improve hair growth and reduce hair loss after 42 and 84 days, as assessed by phototricogram parameters. * Whether the two formulations improve hair brightness, and colour lightness after 42 and 84 days, as assessed by spectrophotometer/colorimeter. Researchers will compare two active supplement groups and a placebo group to determine whether the active products improve objective hair parameters and perceived hair quality. Participants will: * be randomized to one of three groups : Active 1, Active 2 or Placebo; * take one capsule daily at breakfast for 84 days; * attend clinical visits at baseline, Day 42, and Day 84; * undergo hair assessments including pull test, phototrichogram, and spectrophotometer/colorimeter measurements; * complete a self-assessment questionnaire at follow-up visits; * be monitored for safety and tolerability throughout the study.

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 of Pharmacokinetics, Safety, and Immunogenicity of BCD-057 100 mg/mL, BCD-057 50 mg/mL, and Humira 100 mg/mL in Healthy Subjects

The aim of this study is to establish comparability of pharmacokinetic parameters and similarity of the safety and immunogenicity profiles of single subcutaneous doses of BCD 057 100 mg/mL and BCD-057 50 mg/mL, as well as BCD-057 100 mg/mL and Humira 100 mg/mL, in healthy subjects. The study is conducted in a population of healthy male subjects aged 18-45 years inclusive at the time of signing the ICF, with a body mass index in the range of 18.5 to 30.0 kg/m2.

Wearable Resistance Vest for Strengthening Respiratory Muscles

Respiratory muscle weakness significantly limits functional capacity in various populations, yet conventional respiratory muscle training (RMT) often requires coached, mouthpiece-based maneuvers that may be limited by technique and adherence. This proof-of-concept study evaluated the physiological efficacy of a novel, low-cost wearable resistance vest designed to provide continuous circumferential thoracic loading during spontaneous breathing to improve respiratory muscle strength in healthy adult males.

Effects of Cold-Water and Cold-Air Exercise on Appetite, Energy Intake, and Food Preference

This study investigated whether exercising in cold environments affects appetite, energy intake, and food preference compared with exercising in thermoneutral conditions. Eleven healthy males completed five laboratory trials as part of a crossover study: a control trial and four exercise trials performed in cold-water (16°C), thermoneutral water (35°C), cold-ambient air (6°C), and thermoneutral ambient air (26°C). Appetite responses were assessed throughout each trial, and participants were provided with an ad libitum meal after exercise to measure energy intake. Food preference was assessed using the Leeds Food Preference Questionnaire. The study aimed to determine whether environmental temperature and exercise medium influence acute post-exercise eating behaviour.

A Clinical Study to Evaluate the Safety of MF1, a New Treatment for Parkinson's Disease-related Disorders (MF1 Study)

This is a Phase I, investigator-initiated, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of MF1, a novel agent that is expected to inhibit α-synuclein related pathogenesis in α-synucleinopathies, primarily Parkinson's disease (PD). MF1 aims to address the unmet medical need in PD, which affects about 1% of individuals aged 60 years and older in Japan and is projected to reach 43 million patients worldwide by 2050. The trial consists of three parts: Part A (single ascending dose) and Part B (multiple ascending dose) in healthy Japanese male adults, and Part C (multiple dose) in patients with idiopathic PD. Part A is a randomized, double-blind, placebo-controlled, single-center study assessing single oral doses , including a food-effect evaluation. Part B is a randomized, double-blind, placebo-controlled, single-center study with once-daily dosing for 7 days. Part C is an open-label, multicenter study in 4-8 PD patients (MDS 2015 criteria, Hoehn \& Yahr stage ≤3) receiving once daily for 14 days, with or without stable background antiparkinsonian therapy. The primary objective is to assess safety and tolerability; secondary objectives include characterization of plasma, urine, and cerebrospinal fluid pharmacokinetics and assessment of food effect. Exploratory pharmacodynamic endpoints include biomarkers such as α-synuclein, neurofilament light chain, UCHL-1, FABP3, GFAP, and other neurodegeneration markers. Key exclusion criteria include clinically significant systemic diseases, seizure history, serious infections (HBV, HCV, HIV, syphilis), recent suicidal ideation or attempts, and recent use of other investigational products.

Apply Biphasic IVM for POSEIDON Group 1

The goal of this clinical trial is to learn if biphasic In Vitro Maturation (IVM) works to help young women who produce very few oocytes after controlled ovarian stimulation. The study focuses on women under age 35 who have a good number of follicles in their ovaries but do not respond well to standard ovarian stimulation by Gonadotropin (known as POSEIDON Group 1a). The main questions it aims to answer are: How many mature oocytes can be obtain after biphasic -VM? Researchers will use biphasic-IVM system to see if it can bypass the problems these patients face with standard treatments, such as high costs and the risk of medical complications like Ovarian Hyperstimulation Syndrome (OHSS). Participants will: Have their immature eggs collected from the ovaries without the need for high-dose hormone injections. Have their eggs matured in a specialized laboratory using a two-step process (biphasic IVM) to improve egg quality. Follow up with researchers to check the number of embryos created and the safety of the procedure.

The Effects of Beta-Alanine Supplementation on Mechanical Performance, Acid-Base Balance, Oxidative Stress, and Enzymatic Antioxidant Defence During Repeated Wingate Anaerobic Tests Under Normoxic and Hypoxic Conditions

Beta-alanine is a dietary supplement that increases skeletal muscle carnosine concentration and may enhance the muscle's ability to buffer hydrogen ions produced during high-intensity exercise. This buffering effect could potentially delay fatigue and improve exercise performance, particularly under conditions that increase metabolic stress, such as hypoxia. However, previous studies examining the effects of beta-alanine supplementation on repeated sprint performance under hypoxic conditions have produced inconsistent findings. The purpose of this study is to determine whether four weeks of beta-alanine supplementation improves repeated high-intensity cycling performance and influences markers of acid-base balance in trained male cyclists exercising under normoxic and hypoxic conditions. Participants will perform repeated Wingate anaerobic cycling tests before and after a four-week supplementation period with either beta-alanine or placebo. Mechanical performance outcomes, including peak power, mean power, total work, and fatigue indices, will be assessed alongside physiological measures of metabolic stress, including blood lactate concentration, pH, bicarbonate concentration, and base excess. Performance and physiological responses will be compared between supplementation groups and environmental conditions. The findings of this study may contribute to a better understanding of the ergogenic potential of beta-alanine supplementation during repeated high-intensity exercise and provide practical information for athletes and practitioners regarding the effectiveness of beta-alanine under conditions of reduced oxygen availability.

AI-Based Hamstring Injury Risk Analysis and Effects of the FUNBALL Program

This study investigates hamstring injury risk in football players using artificial intelligence-based motion analysis (OpenPose) and evaluates the effects of a targeted exercise intervention (FUNBALL). Hamstring risk is assessed during a 30-m sprint using sagittal-plane video analysis, and players classified as medium or high risk receive a four-month FUNBALL program. A pre-post intervention design is employed, with sprint performance, agility, balance, jumping ability, kicking power, and cognitive function assessed using standardized field and cognitive tests.

Acute Effects of Caffeine on Repeated Sprint Performance and Energy Distribution

The goal of this study is to learn if low-dose caffeinated coffee improves repeated sprint performance and affects energy system contributions in combat sports athletes. The main questions it aims to answer are: * Does low-dose caffeinated coffee (1.5 or 3 mg·kg-¹) improve peak power, mean power, and fatigue index during repeated sprint tests? * What physiological responses (heart rate, blood lactate, perceived exertion, and energy system contributions) do participants have when consuming caffeinated coffee? Researchers compared caffeinated coffee at two doses (1.5 and 3 mg·kg-¹ body mass) to a placebo (decaffeinated coffee of identical taste and appearance) to see if low

A Study to Assess the Pharmacokinetics of GEn-1124 After Single Oral Dosing in Healthy Subjects

The goal of this clinical trial is to determine the pharmacokinetics (how the body interacts with administered substances for the entire duration of exposure) of Gen-1124 in an oral formulation (taken by mouth) in healthy volunteers. It will also learn about the safety of Gen-1124. The main questions it aims to answer are: \- How does Gen-1124 interact with a human body? Researchers will look at how Gen-1124 interacts with the body and what side effects it may cause. Participants will: * Take Gen-1124 for a single dose * Remain in clinic for 2 days for checkups and tests * Recieve a phone call for a checkup 3 and 7 days after the single dose

Effect of Gum Acacia and Electrolytes on Hydration After an Exercise-indued Dehydration

This clinical study is a single-blind, placebo-controlled, three-way cross-over trial evaluating the rehydration efficacy of two nutritional beverages compared to water, after one administration. The investigational products are gum acacia alone, and combined with sea electrolytes as magnesium. Participants, physically active men undergo exercise-induced dehydration followed by controlled rehydration procedure with each product in randomized sequence. The study includes standardized preconditions (diet, hydration, activity control), exercise and rehydration protocols. Gam acacia has the benefit of few preclinic studies in murin models showing significant improvements on electrolytes and water absorption, but its effect on hydration in human has never been evaluated. The combination with sea electrolytes has been developed to optimise and reduce the total concentration of electrolytes into the beverage compared to standard formulations proposed for rehydration in sport application.

Effect of Collavant® n2 in Healthy Male Adults With Exercise-induced Joint Discomfort.

The present clinical study has been designed to evaluate the effect of Collavant® n2 at a daily dose of 40 mg on joint function and performance in healthy, amateur male runners with exercise-induced knee discomfort.

Study on the Mass Balance of [14C]HRS-9190 for Injection in Healthy Participants

To evaluate the absorption, metabolism and excretion after a single intravenous bolus of \[14C\]HRS-9190 in healthy Participants

Effect of Early Time-Restricted Eating on Appetite, Appetite-Regulatory Hormones and Energy Intake

This randomised crossover study's primary aim is to investigate the effect of short-term fasting (eTRE) on subjective appetite and appetite-regulatory hormones (i.e., leptin, adiponectin, total glucagon-like peptide-1 (GLP-1), gastric inhibitory polypeptide (GIP), total peptide YY (PYY), acylated ghrelin and Insulin). In addition, to examine if the one-day early time-restricted eating influences energy expenditure and ad libitum energy intake in the periods following the standard meal test. The researchers will compare normal eating with early Time-Restricted Eating (eTRE) in healthy men.

Examining Olive Oil Extract on Knee Comfort and Function

The goal of this study is to learn if an olive oil extract works to improve knee pain and discomfort in adults. The main questions it aims to answer are: 1) Does the olive oil extract improve the perceptions of knee pain and discomfort, and 2) Does the olive oil extract improve knee function in adults? The main procedures in the study include: * Screening and informed consent * Take one assigned study capsule (supplement or placebo) daily with food for 6 weeks * Complete digital questionnaires about your knee pain, stiffness, and function at scheduled times * Complete a Day 1 acute assessment and two simple functional movement tests at home as described below * If possible, connect a compatible wearable device to allow collection of sleep and physical activity data as detailed below. * Collect saliva samples at home using a provided kit at designated timepoints * Record any pain medications taken during the study or any side effects

A Study to Evaluate the Safety of Increasing Doses of DF5112 in Healthy Adults

This is a double-blind, randomized, placebo-controlled, single ascending dose (SAD) study to evaluate safety, tolerability, pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD) of DF5112 in healthy adult participants. A total of 48 participants are planned to be randomized into 6 cohorts. Additional cohorts at intermediate dose levels may be evaluated. Each cohort will include 8 healthy participants randomized to receive DF5112 or placebo through intravenous (IV) or subcutaneous (SC) administration. Following dose administration participants will be confined at the clinical research unit for observation for approximately 1 week and then will return for subsequent pre-identified follow up visits through Day 29.

A Study to Evaluate the Safety, PK, and Immunogenicity of Recombinant Human Hyaluronidase in Healthy Subjects

The study is being conducted to evaluate the safety, pharmacokinetics, and immunogenicity of recombinant human hyaluronidase in healthy Chinese adult male subjects.

Effects of Dual-Source Carbohydrate Intake and Liver Glycogen Repletion After Overnight Fasting.

This study is looking at whether eating a breakfast which has two different sources of carbohydrates, glucose and fructose (found in foods like honey and fruits), can increase how much glycogen can be stored in the liver. Glucose is a type of sugar that the body uses to provide energy during exercise. When it is not circulating in the blood, it is stored in the muscles and liver. The stored version of glucose is often referred to as glycogen. When the body needs energy, for example, it will break down glycogen into glucose so that it can be used as fuel. Muscle and liver glycogen stores are vital in providing energy during prolonged exercise, and strenuous activity can rapidly deplete these stores, leading to increased fatigue and a decline in performance. Liver glycogen, however, is particularly important because it controls blood glucose levels. This is important because the brain and other organs are constantly relying on the supply of glucose to function properly. When sleeping, the body goes through a natural period of fasting. During this period, the liver gradually breaks down its glycogen stores to release glucose into the bloodstream. Because of this, following sleep, liver glycogen stores are automatically low (which is why having breakfast is important). There is research to suggest that eating a high-carbohydrate breakfast can prevent further declines in liver glycogen; however, it is not known if eating different types of carbohydrates within the breakfast (glucose and fructose together) will affect the liver's ability to store glycogen. This research will aid in understanding optimal ways to increase liver glycogen stores before performing exercise, which may influence exercise performance. Therefore, the main aim of this study is: 1\. Investigate whether a high fructose breakfast will increase liver glycogen storage To achieve this, participants will be recruited to complete a randomised crossover study where they will undertake three different conditions. All laboratory trials will take place at the Manchester Metropolitan University Institute of Sport. 1. No breakfast (Control) 2. 3 g/kg of body mass of carbohydrate (of which contains 0% fructose) 3. 3 g/kg of body mass of carbohydrate (of which contains50% fructose) Liver glycogen stores will be measured using magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). The investigators will measure liver glycogen content, liver volume, and stomach volume. Blood samples will also be taken to measure different metabolic hormone responses.