Bayswater

Researchers are evaluating KT501, a monoclonal antibody, in an open-label, first-in-human Phase 1 study involving adults with Rheumatoid Arthritis RA. The study aims to investigate the safety, tolerability, and how the body processes and responds to a single subcutaneous dose of KT501. This study focuses on participants with moderately to severely active RA who have not responded adequately to previous treatments. Participants will be enrolled into up to 5 different dose groups, each receiving one single subcutaneous injection of KT501 on Day 1. The study includes dose escalation to assess different levels of the drug. After administration, participants are followed closely for 12 weeks to monitor effects, with additional follow-up up to 48 weeks for those who experience significant B cell depletion. During the study, participants will undergo various assessments including monitoring for adverse events, changes in vital signs such as pulse and blood pressure, and laboratory tests on blood and urine. Researchers will measure serum levels of KT501 at multiple time points up to Day 85, track immune responses such as B cell counts, and assess inflammatory markers. The total participation duration may extend up to 48 weeks for some individuals to ensure safety and thorough evaluation.

Researchers are conducting a Phase 1, open-label study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of KT502, a monoclonal antibody targeting CD19 and CD3 to deplete B cells, in adults with Rheumatoid Arthritis RA. This trial focuses on adult participants aged 18 to 75 years who have moderately to severely active RA and inadequate treatment response, aiming to understand how KT502 behaves and is tolerated when given by subcutaneous injection. The study has two parts Part A involves single ascending doses of KT502 to find appropriate dosing levels, while Part B uses fractionated dosing with injections on Day 1 and Day 8 to escalate the dose. Participants receive subcutaneous injections of KT502 at assigned doses according to their group, with dosing schedules designed to assess safety and drug behavior. Participants will be monitored for up to 12 weeks after dosing for adverse events, vital signs, and laboratory changes including blood chemistry and hematology. Additional blood samples will be taken at various time points to measure drug concentrations, immune response, and inflammation markers. The study includes regular assessments to track safety, drug levels, and immune effects over approximately three months, with ongoing data collection on laboratory and clinical parameters.

Researchers are evaluating S-4321 in this first-in-human, phase 1 clinical trial to gather information on its safety, tolerability, and how the body processes and responds to it. The study involves healthy adult volunteers and aims to provide initial data on potential effects and biological activity of S-4321 compared to a placebo. This randomized, double-blind, placebo-controlled study is sponsored by Seismic Therapeutic AU Pty Ltd and includes two parts to test different dosing schedules. The trial has two parts Part 1 where participants receive single ascending doses of S-4321 or placebo, and Part 2 where participants receive multiple ascending doses, administered either subcutaneously or intravenously. This design allows researchers to carefully monitor how the drug behaves in the body at different dose levels and over time. Both S-4321 and placebo are given under controlled conditions during these periods. Participants are closely monitored through various safety assessments and laboratory tests over about two months. The main focus is on any treatment-related adverse events. Researchers will also measure how much of the drug enters the bloodstream, how long it stays, and how it affects receptor occupancy. Additional evaluations include antibody response against the drug. Participants must be available for the entire study period and follow-up to ensure complete data collection.

This research aims to evaluate the safety and tolerability of LIFE-001 in healthy adult volunteers aged 18 to 65 years. The study is a Phase I trial focusing on single ascending doses SAD and multiple ascending doses MAD to understand how the drug behaves in the body and its effects. It is designed to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of the investigational drug LIFE-001 compared to placebo. Participants will be assigned to one of several cohorts receiving either single or multiple subcutaneous doses of LIFE-001 or placebo. The SAD cohorts involve dosing between 10mg and 1500mg with a 6-day inpatient stay and a total duration of up to 51 days. MAD cohorts receive multiple doses ranging from 50mg to 1500mg on various schedules, including weekly or twice weekly injections, with inpatient stays of 5 to 6 days and total participation lasting up to 91 days. Dose escalations depend on safety and tolerability reviews by a safety committee. During the study, participants will attend scheduled visits for dosing and monitoring under fasting conditions. Assessments include tracking adverse events, plasma drug concentrations, and pharmacokinetic measures such as maximum concentration and time to maximum concentration at specified intervals post-dosing. Safety monitoring includes physical examinations, ECGs, laboratory testing, and drug and alcohol screening. The total participation duration varies by cohort but includes screening, inpatient stays, and follow-up visits extending up to 91 days.

Researchers are evaluating the pharmacokinetic similarity between B-3E07 and Forsteo in healthy adult female volunteers aged 18 to 45 years. This phase 1, randomized, double-blind crossover study aims to compare how these two biologic injections behave in the body, including their safety, immune response, and drug levels in the bloodstream. Participants will receive single subcutaneous injections of B-3E07 and Forsteo in two separate treatment periods with a 14-day washout between doses. One group receives B-3E07 first, followed by Forsteo, while the other group receives Forsteo first, then B-3E07. After the final dose, there is a 14-day follow-up to monitor effects. During the study, participants will have blood samples taken before and up to 6 hours after dosing to measure maximum drug concentration and overall exposure. Additional assessments include safety monitoring for adverse events, injection site reactions, vital signs, ECGs, and laboratory tests. The study lasts approximately 53 days from dosing to final follow-up.

Researchers are evaluating the safety, tolerability, and pharmacokinetics of FB1003, a drug given by subcutaneous injection, in both healthy adults and adults with osteoarthritis OA pain. The study aims to understand blood exposure, concentration, and half-life of FB1003, as well as its effects on disease activity and pain in OA patients. This is a phase 1, randomized, double-blind, placebo-controlled trial sponsored by 4B Technologies Limited. Participants are divided into cohorts receiving single ascending doses SAD or multiple ascending doses MAD of FB1003 or placebo. The trial includes healthy volunteers and adults with knee OA pain who meet specific diagnostic and pain criteria. The dosing is administered under close monitoring, with groups receiving different dose levels in a randomized manner. Throughout the study, participants will undergo blood tests to measure drug levels, immune response, and safety parameters. Assessments include monitoring adverse events, disease activity changes, and pain scores over periods up to 12 or 18 weeks depending on the study part. Researchers will closely observe safety and tolerability from baseline through the study end, with detailed follow-up visits and laboratory tests.

Researchers are evaluating CPTX2309, an intravenous drug, to study its safety and tolerability in healthy adults and adults with moderate to severe rheumatoid arthritis RA or systemic lupus erythematosus SLE. This Phase 1, open-label trial investigates both single ascending doses and multiple ascending doses of CPTX2309. The study aims to understand how the drug is tolerated and its potential effects in these populations. The study includes four parts Part A and C involve escalating single doses of CPTX2309 given on specific days, while Part B and D involve escalating multiple doses administered on specified days. These parts are conducted in both healthy adults and adults with moderate to severe RA or SLE. The drug is administered intravenously, and dose escalation allows assessment of safety across increasing doses. Participants will be monitored for up to approximately one year to assess safety parameters including laboratory tests, vital signs, ECGs, antibody development against the drug, and immune responses. Researchers will also measure pharmacokinetic and pharmacodynamic parameters. Study visits will follow a schedule to track these outcomes and ensure participant safety throughout the trial duration.

Researchers are conducting a Phase 1 study to evaluate the safety, tolerability, and pharmacodynamics of SYNT-101, a drug being studied in healthy and overweight adults aged 18 to 55. This randomized, double-blind, placebo-controlled trial aims to understand how the drug behaves in the body and its safety profile. The study is sponsored by Syntis Bio and focuses on initial human testing to gather important information about SYNT-101. Participants will receive either SYNT-101 tablets or matching placebo tablets in single ascending doses and multiple ascending doses. The study involves carefully controlled dosing schedules to monitor how the drug is processed in the body over time. Both single and repeated doses will be tested to assess safety and drug levels in the blood. During the study, participants will undergo safety evaluations from enrollment through up to 36 days after dosing, including monitoring for adverse effects. Blood samples will be collected at multiple time points after dosing to measure drug concentration and pharmacokinetics. Volunteers will be asked to comply with all study assessments and follow the protocol throughout the trial, which includes frequent visits and monitoring by the research team.

Researchers are conducting a Phase 1 clinical trial to study MWN109 tablets in healthy adult volunteers. The study aims to evaluate the safety, tolerability, pharmacokinetics how the drug moves through the body, pharmacodynamics how the drug affects the body, and immunogenicity immune response of MWN109. The trial involves adults aged 18 to 60 years and includes both single and multiple ascending dose phases to understand the drugs effects better. The trial has two parts a single ascending dose SAD phase and a multiple ascending dose MAD phase. In the SAD phase, participants receive one oral dose of MWN109 or placebo in four dose levels 7.5mg, 15mg, 30mg, and 45mg. In the MAD phase, participants receive daily doses of MWN109 or placebo for 28 or 30 days, with doses determined based on safety and pharmacokinetic data from the SAD phase. The study uses a randomized, double-blind, placebo-controlled design, meaning neither participants nor researchers know who receives the drug or placebo during the trial. Participants will be closely monitored throughout the study, which lasts up to 8 weeks for the SAD part and 12 weeks for the MAD part. Researchers will assess safety by tracking adverse events, vital signs, ECG changes, physical exams, laboratory tests, and immune responses. Pharmacokinetic measures such as drug concentration over time will also be collected. Participants will follow study requirements including maintaining stable diet and activity levels, and contraception use. The study is led by Shanghai Minwei Biotechnology Co., Ltd and aims to end after the last participants final visit in May 2026.

Researchers are studying the effects of a drug called IBIO-600 in adults who are overweight or obese. The goal is to find the best dose that balances safety, tolerability, and impact on body composition. This Phase 1, first-in-human, randomized, double-blind, placebo-controlled study also examines how the drug moves through and affects the body and how the immune system responds. Participants receive a single subcutaneous injection of either IBIO-600 at different dose levels or a matching placebo. The study involves ascending doses given to separate groups to evaluate safety and drug behavior. Participants are monitored for 9 months after the dose to assess effects on body composition and physical function. During the study, participants undergo various assessments including safety and tolerability checks, blood tests to measure drug levels and immune response, and evaluations of body composition and physical activity. Safety is monitored from the first day until the end of the study at 252 days. The trial lasts about 9 months, during which researchers carefully track how the drug affects participants and any side effects that occur.