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Healthy Volunteers clinical trials

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NCT ID: NCT06415019 Not yet recruiting - Pain Clinical Trials

A Study to Learn About Whether BAY H006689 Causes an Allergic Reaction When Applied as a Topical Gel in Healthy Participants

Start date: May 21, 2024
Phase: Phase 1
Study type: Interventional

Researchers are looking for a better way to treat muscle and joint pain. Researchers have seen that medicines which help reduce pain and inflammation could be safer when applied directly to the skin, called topical application, than when taken by mouth. However, recent studies have found that using these medicines on the skin can sometimes cause skin reactions such as redness, itching, or irritation in the area where the medicine is applied. However, reports of more serious side effects, affecting the entire body, from using these topical medicines are uncommon. The study treatment BAYH006689 is under development to treat muscle and joint pain. In this study, participants will be healthy and will not benefit from BAYH006689. However, the study will provide information on how to test BAYH006689 in future studies in people with muscle and joint pain. The main purpose of this study is to check if BAYH006689 topical gel causes any skin reactions in healthy participants. The skin reactions will be assessed using a scale. This scale will provide scores for redness, swelling, and other signs of skin irritation. In this study, researchers will randomly assign 3 sites, adjacent to each other, on the back of participants' bodies just below the shoulder blades. The following gels will be applied 10 times at these sites as a patch three times a week for 21 days and once after 14-17 days: - BAYH006689 - Placebo, which looks like the study drug but does not have any medicine in it. - 0.9 % saline Each participant will be in the study for around 6 to 8 weeks. During this time they will: - receive assigned treatment gels at the identified skin sites - have their skin reaction symptoms assessed During the study, the doctors and their study team will: - check the medical history of the participants - check participants' health by performing urine tests - ask the participants questions about how they are feeling and what adverse events they are having An adverse event is any medical problem that a participant has during a study. Doctors keep track of all adverse events, irrespective of whether they think they are related or not to the study treatment.

NCT ID: NCT06414798 Not yet recruiting - Healthy Volunteers Clinical Trials

A Study to Assess the Safety, Tolerability, and Pharmacokinetics of ABBV-1088 Oral Dose in Healthy Adult Participants.

Start date: May 13, 2024
Phase: Phase 1
Study type: Interventional

This study will assess the single dose safety, tolerability and pharmacokinetic properties of ABBV-1088 in healthy adult participants

NCT ID: NCT06408857 Not yet recruiting - Healthy Volunteers Clinical Trials

Study To Evaluate Safety, Tolerability, and Pharmacokinetics of MAM01 in African Population

Start date: September 2024
Phase: Phase 1
Study type: Interventional

This study will test a new drug (MAM01) to find which doses are safe and could help prevent people from getting malaria. The study will take place in parts of Africa where malaria is common. Parts A and B of the study will first test single doses of MAM01 in healthy adults, then after safety review, in older children, and then after additional safety review, in infants. Part C will then test single doses of MAM01 in children and infants who have a medical problem that could put them at greater risk if they get malaria.

NCT ID: NCT06402513 Not yet recruiting - Healthy Volunteers Clinical Trials

A Study in Healthy Adult Participants to Assess the Pharmacokinetics, Immunogenicity, Safety, and Tolerability of a Ravagalimab Subcutaneous Formulation in a Pre-Filled Syringe

Start date: June 24, 2024
Phase: Phase 1
Study type: Interventional

The objective of this study is to assess the pharmacokinetics, immunogenicity, safety, and tolerability, of subcutaneous formulation of ravagalimab in a pre-filled syringe in healthy adult participants.

NCT ID: NCT06398730 Not yet recruiting - Healthy Volunteers Clinical Trials

A Phase 1, Dose-Escalation, Positron Emission Tomography Study to Assess the Safety, Pharmacokinetics, Dosimetry and Biodistribution of GEH200521 (18F) Injection Co-Administered With GEH200520 Injection in Healthy Volunteers

Start date: May 2024
Phase: Phase 1
Study type: Interventional

This is a Phase 1, single-center, open-label, single-arm, dose-escalation positron emission tomography study to assess the safety and tolerability, immunogenicity, Pharmacokinetics, dosimetry, and biodistribution after GEH200521 (18F) Injection is co-administered with GEH200520 Injection in healthy volunteers. The estimated study duration for each subject is approximately 28 days. The primary study objective is to evaluate the safety and tolerability of the IMPs, the selected mass doses of GEH200520 Injection co-administered with a fixed dose of GEH200521 (18F) Injection.

NCT ID: NCT06398340 Not yet recruiting - Healthy Volunteers Clinical Trials

Identifying Wearable Biomarkers to Monitor Dietary Intake

FoodSense
Start date: May 1, 2024
Phase: N/A
Study type: Interventional

Background: Measuring what people eat is a challenge in nutrition research. Traditional methods, like food diaries, rely on self-reporting of individuals, and suffer from poor accuracy and recall bias. Aims: This project aims to identify physiological biomarkers related to food and energy intake, which may be used to develop an objective tool to estimate individuals' food intake in future. Eating behaviours are accompanied by significant physiological changes such as skin temperature, blood oxygen saturation, pulse rate etc. The investigators intend to investigate whether monitoring these physiological changes can help us estimate eating behaviour, such as meal size, eating speed, and duration of meals. Study design: Ten healthy adults will be invited for two study visits at NIHR Imperial Clinical Research Facility. Each visit will last for approximately 2 hr. They will consume a high- and low-calorie meal designed by nutritional researchers in a randomised order. During eating events, the investigators will track their physiological changes via a bedside monitor and wearable sensors. Blood samples will be taken from participants to measure their glycaemic response. Associations between energy load, glycaemic response, and physiological changes will be investigated. Our findings may promote an accelerated development of a wearable tool for dietary assessment in future.

NCT ID: NCT06388239 Not yet recruiting - Healthy Volunteer Clinical Trials

Bioequivalence Study of Apixaban 5 mg Film-coated Tablets in Healthy Thai Volunteers

Start date: August 26, 2024
Phase: Phase 1
Study type: Interventional

The goal of this bioequivalence of two formulations of generic apixaban 5 mg film-coated tablets. Single-dose under fasting conditions and pharmacokinetics will be characterized for a total of 28 healthy adult human subjects. Twenty-eight (28) subjects will be randomly assigned to receive either generic apixaban 5 mg film-coated tablets (1 x 5 mg; Test) or ELIQUISTM (1 x 5 mg; Reference) in Period 1 and after the washout period they will receive the other formulation as a crossover fashion in Period 2.

NCT ID: NCT06386211 Not yet recruiting - Healthy Volunteers Clinical Trials

Bioavailability Study of Magne-B6 New Formulation

Start date: May 6, 2024
Phase: Phase 1
Study type: Interventional

The purpose of the study is to assess the relative bioavailability of two Magne-B6 preparations, in fasting conditions.

NCT ID: NCT06374706 Not yet recruiting - Stroke Clinical Trials

Effects of End-Effector Type Rehabilitation Robots-Morning Walk on Symmetrical Walking Patterns in Individuals With Hemiparesis

Start date: December 1, 2024
Phase: N/A
Study type: Interventional

In this study, our objective is to explore and evaluate interventions to improve the process of recovery following a stroke. The main focus is on enhancing symmetrical walking patterns in adults who have experienced neurological deficits due to a stroke. The primary tool will be an end-effector type rehabilitation robot, the Morning Walk®. This robot has been specifically designed to assist in enhancing symmetrical walking patterns for individuals recovering from a stroke Morning Walk® has received approval from the FDA, meaning it meets stringent safety and efficacy standards.

NCT ID: NCT06369454 Not yet recruiting - Healthy Volunteers Clinical Trials

A Study to Learn About How Different Forms of the Study Medicine Called Ritlecitinib Pass the Intestines of Healthy Male Adults When Taken With or Without Food

Start date: May 1, 2024
Phase: Phase 1
Study type: Interventional

The purpose of this study is to learn about how different forms of the study medicine called ritlecitinib pass the intestines of healthy male adults when taken with or without food. This study is seeking healthy participants who have: - Aged 18 years or older; - male who are healthy as determined by medical assessment; - BMI of 16-32 kg/m2, and a total body weight >45 kg (99 lb). All participants in this study will receive a ritlecitinib oral dose in two different forms (solution without food, capsule with or without food). The study will take up to 3 months, including the screening period and follow-up phone call. Participants will have to stay at the study clinic for at least 11 days. There will be 3 periods in total, and a washout period of at least 3 days between dosings in Period 1 and Period 2, and at least 7 days between dosings in Period 2 and Period 3 for this study. On day 1 of each period, participants will take one form of Riltecitinib without food for the first two periods and with food for the last period. Participants will have blood samples taken both before and after taking ritlecitinib. A follow-up phone call will be made at 28 to 35 days after the last study period.