There are about 173942 clinical studies being (or have been) conducted in United States. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The purpose of the first-in-human (FIH) study is to obtain safety, tolerability, and pharmacokinetic information on SAR442501 in a healthy adult volunteer population using an integrated single ascending dose (SAD)-multiple ascending dose (MAD) parallel cohort study design.
Primary Objective is the tolerability and safety of ascending single and repeated intravenous infusion (IV) and/or subcutaneous (SC) administration of SAR441344
Women often experience significant pain during their periods which can significantly impact on quality of life. In this study, two products that are used to alleviate period pain will be examined. One test product is botanically based, and the other is a traditional over-the-counter pain reliever with additional components added to support less painful periods. The trial will be a cross-over trial where participants will use the botanical product before, during, and after their first period. Participants will use the botanical product alongside a traditional over-the-counter period product during their second period. Participants will answer surveys and have blood drawn at a third-party lab to answer the main objectives of this trial.
Cardiorespiratory fitness (CRF), also known as "exercise capacity", is the capacity of respiratory and circulatory systems to supply oxygen to skeletal muscle during exercise for the generation of energy. Determinants of CRF include lung capacity, capillary density, cardiac output, hemoglobin concentration, and mitochondrial function. The research group studies how CRF is related to fuel utilization, yielding a mechanistic understanding of the association between lower CRF and worsening metabolic health via mitochondrial function. The objective of this study is to measure fuel utilization in response to habitual diet for one week in adolescents and young adults, ages 14-22 years (n=30). Fuel utilization will be estimated by glucose measures using a continuous glucose monitor (CGM). Habitual dietary intake will be collected via a mobile phone application (BiteAI, Inc) that uses artificial intelligence to extract nutrient information from food photographs. Participants will undergo two standard of care (SOC) meal tolerance tests at home - a glucose tolerance test and a Ensure® mixed meal tolerance test. CRF will be estimated by measuring maximum oxygen consumption (VO2 max) during a graded treadmill test. The hypothesis is that a higher VO2 max will be associated with increased fuel utilization, measured by lower glucose response to the SOC meal tolerance tests. The proposed study is described in the following aims: SPECIFIC AIM 1. Test for feasibility of completion of self-report dietary food records, completion of two at home meal tolerance tests that are standard of care for metabolic health screening, and completion of a seven-day continuous glucose monitor. SPECIFIC AIM 2. Identify nutrients and foods that are associated with an elevated glucose response. SPECIFIC AIM 3. Assess the influence of VO2 max on the glucose response to the SOC glucose tolerance test and Ensure® mixed meal tolerance test.
The purpose of the study is to estimate the relative bioavailability of 2 new UCB0599 formulations under elevated and normal gastric pH conditions in healthy participants (Part A) and to asess the safety, tolerability and pharmacokinetics of UCB0599 in healthy participants of Japanese and Chinese origins (Part B).
The goal of this clinical trial is to test the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of of repeat doses of DCR-AUD in adult healthy volunteers who are social drinkers. The main questions it aims to answer are: - Are repeat doses of DCR-AUD safe and well-tolerated in healthy adults who are social drinkers? - How does the drug behave inside the human body and how it is removed from the human body? - What are the symptoms the drug may cause with alcohol consumption? Participants will: - Receive multiple doses of DCR-AUD. - Have assessment visits through Week 24. - Participate in up to 10 Ethanol Interaction Assessments (EIAs) to see how the body is affected by DCR-AUD. Researchers will compare the groups of participates who receive study drug with the group of participants who receive placebo to see if the study drug is safe and tolerable and whether the study drug has any real effect.
The purpose of this study is to investigate the population pharmacokinetics of acetaminophen and naproxen from a novel acetaminophen /naproxen sodium fixed combination tablet in adolescents 12 to less than (<) 17 years of age with post-procedure orthodontic pain and to describe the effect of subject-specific covariates, including age and body weight, on inter-subject variability in acetaminophen and naproxen pharmacokinetics in adolescents 12 to <17 years of age with post-procedure orthodontic pain.
The primary study objective is to establish the safety and tolerability of MT101-5 after a single and multiple dose administrations in healthy volunteers. The safety and overall tolerability of MT101-5 will be evaluated based on: - Incidence of Dose Limiting Toxicities (DLTs) - Incidence of Treatment-Emergent Adverse Events (TEAEs). - Incidence of withdrawals due to Adverse Events (AEs). - Change/shifts in laboratory values. Change in vital signs. - Change in Electrocardiogram (ECG) parameters. - Changes in physical examination findings
This is a single center randomized parallel-group partially-blinded, 4-arm Phase 1 study to evaluate the phototoxic potential of two dose levels of SAR441566 treatment compared to placebo and the active comparator, ciprofloxacin, in healthy adults, 18 to 55 years of age. There will be two parts: - Part I is a randomized placebo-controlled trial comparing sensitivity to ultraviolet (UV) light in participants treated with SAR441566 to those treated with placebo. - Part II is an open label arm consisting of participants treated with ciprofloxacin which induces mild phototoxicity and serves as a positive control.
The primary objective of this study is to evaluate the feasibility of implementing blood-based biomarker testing for amyloid positivity designed to aid the early detection of Alzheimer's Disease and Related Dementia (ADRD) in patients 65+ including the rate that patients and providers follow up abnormal blood-based biomarker testing.