Bayswater

Researchers are evaluating KT501, a monoclonal antibody, in adults with Rheumatoid Arthritis (RA) to study its safety, tolerability, and how it is processed and acts in the body. This Phase 1, open-label, first-in-human trial focuses on participants aged 18 to 75 with moderately to severely active RA who have not responded adequately to prior treatments. The study aims to understand the effects of a single subcutaneous dose of KT501 in this population. Participants will receive one subcutaneous injection of KT501 on Day 1. Up to five groups of participants, totaling approximately 24 individuals, will be enrolled for dose escalation. Those with lower than baseline B cell levels after treatment will have additional monitoring of B cells for up to 48 weeks. All participants will be followed up for 12 weeks after dosing for safety and pharmacological assessments. During the study, participants will be monitored closely for adverse events, including cytokine-release syndrome, and changes in vital signs such as pulse, respiratory rate, blood pressure, and temperature. Laboratory tests will assess hematology, chemistry, urinalysis, and coagulation parameters from baseline up to 12 weeks. The study includes thorough safety evaluations and follow-up to understand the drug's impact on the participants over time.

Researchers are conducting a Phase 1, randomized, placebo-controlled, double-blind study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of S-4321 in healthy adult volunteers. This first-in-human trial aims to gather initial data on how the drug behaves and is tolerated in the body compared to a placebo. The study includes adults aged 18 to 65 years in good physical and mental health. The trial has two parts: Part 1 involves single ascending doses (SAD) of S-4321 or placebo, and Part 2 involves multiple ascending doses (MAD) administered either subcutaneously or intravenously. Participants will receive either the investigational drug S-4321 or a matching placebo following the study's dosing schedule. The double-blind design means neither participants nor researchers know who receives the drug or placebo. Participants will be closely monitored throughout the study, including during follow-up visits, to assess safety and any adverse events related to the treatment over two months. Researchers will collect data through various assessments to evaluate the drug's effects and tolerability. The study also involves adherence to protocol schedules and restrictions to ensure reliable and safe participation.

Researchers are evaluating the safety and tolerability of LIFE-001 in healthy adult volunteers aged 18 to 65 years. This Phase I clinical trial aims to learn how participants respond to different doses of LIFE-001 given by subcutaneous injection. The study includes both single ascending dose and multiple ascending dose groups to carefully monitor effects and adjust dosing based on safety and tolerability results. Participants will take part in either the Single Ascending Dose (SAD) or Multiple Ascending Dose (MAD) cohorts. In SAD, participants receive one subcutaneous dose of LIFE-001 ranging from 10mg to 750mg or placebo under fasting conditions, with a screening period of up to 28 days and a 6-day inpatient stay, totaling up to 51 days. In MAD, participants receive four subcutaneous doses of LIFE-001 or placebo between 50mg and 750mg administered seven days apart on Days 1, 8, 15, and 22, with two 6-day inpatient stays and a total duration of up to 91 days. Dose levels for later cohorts depend on safety, tolerability, and pharmacokinetic data reviewed by a safety committee. During the study, participants will undergo health assessments including monitoring for adverse events before dosing and through follow-up days (up to Day 22 for SAD and Day 56 for MAD). Researchers will collect safety and pharmacokinetic data to evaluate how participants tolerate the drug and how it behaves in the body. The total participation may last up to 91 days depending on the cohort. Safety is closely monitored throughout the study to protect participants' well-being.

Researchers are evaluating the pharmacokinetic similarity between B-3E07 and the European Union-sourced Forsteo® in healthy adult female volunteers aged 18 to 45 years. This phase 1 study aims to compare how the body absorbs, processes, and reacts to these two biologic treatments using detailed blood measurements. Participants receive single subcutaneous injections of either B-3E07 or Forsteo® in a randomized, double-blind, two-sequence crossover design. Each treatment period involves monitoring drug levels in the blood from before dosing up to six hours after injection to assess maximum plasma concentration and total drug exposure over time. During the study, volunteers undergo blood tests, physical exams, vital sign checks, and pregnancy tests to ensure safety and monitor drug effects. Researchers measure primary outcomes such as peak drug concentration and area under the concentration-time curve. The study requires participants to follow contraception rules and avoid substances that may interfere with assessments, with all procedures completed within the defined treatment periods.

Researchers are evaluating the safety and tolerability of FB1003 given as a subcutaneous injection in healthy adults and adults with osteoarthritis (OA) pain. This Phase 1 study also examines the blood levels, concentration, and half-life of FB1003. The study includes two parts: Part 1 focuses on healthy participants, while Part 2 involves adults with OA knee pain confirmed by X-rays and clinical criteria. The study aims to understand how FB1003 behaves in the body and assess any side effects compared to placebo. Participants will receive either FB1003 or a placebo through subcutaneous injections. The study includes a single ascending dose (SAD) phase lasting up to 12 weeks for healthy volunteers and a multiple ascending dose (MAD) phase lasting up to 18 weeks. Part 2 assesses the safety, tolerability, pharmacokinetics, and efficacy of a single ascending dose in adults with OA pain. Participants in Part 2 must have moderate to severe knee pain and meet specific diagnostic criteria. During the study, participants will undergo blood tests to monitor drug exposure and safety. Researchers will track treatment-emergent adverse events from the start until the end of the study, which can last up to 56 days for SAD and up to 84 days for MAD. Participants will be monitored regularly through physical exams, vital signs, ECGs, and laboratory tests. The study also includes assessments of knee pain and function for OA subjects, with safety and tolerability as key outcomes.

Researchers are conducting a Phase 1 study to assess the safety, tolerability, and pharmacodynamics of SYNT-101 in healthy and overweight adults aged 18 to 55. This randomized, double-blind, placebo-controlled trial aims to evaluate single and multiple dose regimens of the medication to better understand its effects in these populations. Participants will receive either SYNT-101 tablets or matching placebo tablets. The study includes both single ascending dose (SAD) and multiple ascending dose (MAD) periods, with safety monitored closely during these phases. The study is designed as a single-center trial with careful dose escalation and control measures. During the study, participants will undergo blood sampling and various assessments to monitor safety and drug effects. Safety evaluations will occur from enrollment up to 7 days after dosing in the single-dose phase and up to 36 days after dosing in the multiple-dose phase. Participants must adhere to the study schedule and restrictions throughout the trial period, ensuring thorough monitoring and data collection.

Researchers are investigating the safety, tolerability, pharmacokinetics, pharmacodynamics, and immune response of MWN109 tablets in healthy adults. This Phase 1 study includes participants aged 18 to 60 years with a range of body mass indexes related to overweight or obesity. The study aims to understand how different doses of MWN109 behave in the body and how safe and tolerable they are when taken orally. The study is divided into two parts: a single ascending dose (SAD) phase and a multiple ascending dose (MAD) phase. In the SAD phase, participants receive a single oral dose of MWN109 or placebo in sequential cohorts. The MAD phase involves multiple doses, with dose levels and timing decided based on safety and pharmacokinetic data from the SAD phase. MWN109 tablets are given in strengths ranging from 4 mg to 45 mg, while the placebo is also administered orally. Participants will be closely monitored through various assessments including laboratory tests, 12-lead ECGs, vital signs, physical exams, and tracking for any adverse events or immune reactions. Safety evaluations occur up to Day 22 for the SAD phase and up to Day 56 or 58 for different cohorts in the MAD phase. Participants are expected to be involved for up to 8 weeks in the SAD phase or 12 weeks in the MAD phase, with careful oversight to ensure safety and gather detailed data on the body's response to the treatment.

This research aims to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of the drug MKP10241 in adults who are obese, with or without type 2 diabetes mellitus (T2DM), across three parts. The study investigates how food affects the PK parameters after a single dose in healthy participants, examines changes in plasma PK and PD profiles after multiple ascending doses in obese participants, and monitors treatment emergent adverse events and discontinuations following these doses. This is a Phase 2a, double-blind, randomized, placebo-controlled trial.

Researchers are evaluating the safety of a new treatment called SORT-COPD (Small Mobile Stem Cells or SMS cells) for people aged 39 to 69 with mild to moderate chronic obstructive pulmonary disease (COPD). This is a Phase 1, first-in-human, open-label study involving 18 participants. The main goal is to understand how safe this stem cell therapy is when delivered directly into the lungs as a potential organ regeneration therapy. The treatment involves inhaling a mist containing SMS cells through a medical nebulizer on days 1, 4, and 8. Participants are divided into three groups of six, each receiving a different dose: low (1.2 billion cells/ml), medium (2.4 billion cells/ml), and high (4.8 billion cells/ml). Between dose groups, there is a pause to monitor for any short-term side effects. Each nebulizer session takes about 10 to 15 minutes, delivering 3 milliliters of the cell suspension. Participants will be involved in the study for about 5 to 6 weeks, including screening, treatment, and follow-up visits. Safety checks include monitoring adverse events, dose-limiting toxicities, and lab tests at multiple time points up to 6 months after treatment. After the initial period, participants will be contacted by phone 3 to 6 months later to check on their health. Individual participation may last up to 15 months in total.

Researchers are evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of a drug called HXN6005 in healthy adult volunteers. This Phase I clinical trial compares HXN6005 with a placebo to gather initial information about how the drug behaves in the body and how well it is tolerated. The study includes healthy men and women aged 18 to 55 years, aiming to understand the effects of the drug in a controlled setting. The study is organized into four groups called cohorts, with three groups receiving increasing doses of HXN6005 and one group receiving a set dose. Each group includes healthy participants who will get either the drug or a placebo in a blinded manner, meaning neither the participants nor the researchers know who receives which treatment. Participants receive a single subcutaneous dose of HXN6005 or placebo on the first day. Blood samples are taken following dosing to analyze the drug's behavior, and participants are monitored for up to 141 days with possible scheduling adjustments based on safety data. Throughout the study, participants visit the clinic for tests and follow-up assessments, including physical exams, lab tests, and heart monitoring. Researchers watch for any adverse events and collect data related to the drug’s safety and how it is processed by the body. Participants must follow study procedures and communicate with the research team. The main outcome measured is the number of participants experiencing any adverse events up to day 141, ensuring careful safety monitoring over the study period.