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The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity after single ascending doses (SAD) of ABBV-141 in healthy adult Western and Asian participants.
Verasone™ is an aqueous suspension of the combination of two marketed drugs to be dosed by sinonasal irrigation in the treatment of Chronic Rhinosinusitis (CRS). This Phase 1 first-in-human study will assess the safety, tolerability, and pharmacokinetics (PK) of single and multiple ascending doses of Verasone versus placebo in healthy normal participants and will evaluate the PK profiles of the Verasone active components administered individually vs in combination.
This is a single center, double-blind, randomized, placebo-controlled, single ascending subcutaneous dose study in lean to overweight or obese but otherwise healthy men. It is planned to enroll 4 cohorts of 8 subjects (Regimens A, B, C and D), with 2 additional optional cohorts of 8 subjects (Regimens E and F). Within each cohort, subjects will be randomized in a ratio of 6 active to 2 placebo. The primary objective is to assess the safety. Secondary objectives are to characterize the pharmacokinetics (PK) and to investigate pharmacodynamic effects.
Although the cause of persistent non-specific low back pain (LBP) remains unknown, structural and functional alterations of the brain, alterations in the lumbar muscles and dysfunction of the central nervous system have been proposed as underlying mechanisms. In this case-control study, 1) brain structure/function, 2) lumbar muscle function and 3) central pain processing are compared across four groups: 1) healthy participants, 2) recurrent LBP (both during pain flare and during pain remission), 3) chronic LBP and 4) fibromyalgia. According to previous research, healthy participants and fibromyalgia patients are two extremes of a "musculoskeletal pain continuum". Healthy participants representing one extreme of the continuum with no pain and fibromyalgia representing the other extreme of the continuum with chronic widespread pain. It is thought that different LBP populations (i.e. (sub)acute, recurrent, chronic LBP) float between the aforementioned extremes. Past studies already highlighted the need for studies comparing the pathophysiological mechanisms for different pain syndromes to identify common underlying mechanisms across pain syndromes. For this reason, the goal of the current study is to compare alterations in brain structure/function, alterations in lumbar muscle function and alterations in central pain processing across the aforementioned "musculoskeletal pain continuum". It is hypothesized that longer duration of pain (recurrent vs chronic) and the extensiveness of the pain (one location vs widespread pain) are associated with more pronounced alterations in 1) brain structure/function, 2) lumbar muscle function and 3) central pain processing.
This study is a single-dose, open-label, randomized crossover study to evaluate the PK of azelaprag in older adult healthy volunteers.
The purpose of this study is to compare the safety, tolerability, pharmacokinetic (PK), and comparative bioavailability of repeated administration of GSBR-1290 in healthy overweight/obese participants.
This study is researching an experimental drug called REGN13335. This is the first time that REGN13335 will be given to people. This study will enroll healthy adults. The aim of the study is to see how safe and tolerable REGN13335 is in healthy volunteers. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - How much study drug is present in the blood of study participants at different times - Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)
The goal of this clinical study was to learn more about BAY1747846 compared to placebo when given as an injection into the vein in Chinese healthy male participants: - the safety of BAY1747846 when given at increasing single doses - the level of BAY1747846 in the blood over time when given at increasing single doses. To answer the first question, the researchers compared the number and severity of medical problems the Chinese participants had after receiving BAY1747846 at increasing doses and placebo respectively. Doctors kept tracking of all medical problems that happened in the study, even if they did not think they might be related to the study treatments. To answer the second question, the researchers determined: - the (average) total level of BAY1747846 in the blood, also called AUC - the (average) highest level of BAY1747846 in the blood, also called Cmax - how BAY1747846 is removed from the blood, also called clearance (CL).
The purpose of this study is to assess the safety and immunogenicity of a single intramuscular (IM) injection of different doses of an respiratory syncytial virus (RSV) and human metapneumovirus (hMPV) vaccine candidate, in adult participants aged 60 years and older. In addition, the study will evaluate the safety and immunogenicity of a booster vaccination administered 12 months after the primary vaccination in a subset of the study population.
This blinded placebo-controlled study is designed to evaluate the safety, tolerability, and PK in healthy participants of a single- and multiple-doses (SAD and MAD) of a new investigational drug: NUV001