Kotara

Researchers are evaluating the safety, tolerability, pharmacokinetics, and effectiveness of IG3018 tablets in adults aged 18 to 75 years with hyperuricemia, with or without chronic kidney disease (CKD). This Phase I/II clinical study includes participants both without CKD and those with advanced predialysis CKD (Stages 3a, 3b, and 4). The study aims to understand how IG3018 affects serum uric acid levels and overall safety in these groups. The study has two parts. Part 1 is a randomized, double-blind, placebo-controlled dose escalation trial involving hyperuricemia subjects without CKD. Participants receive IG3018 tablets starting at 0.25 g, with planned dose increases to 0.5 g and then 1.0 g. Part 2 is an open-label proof-of-concept study including subjects with advanced CKD who receive either 0.5 g or 1.0 g of IG3018 twice daily. The IG3018 and matching placebo are given orally. Participants will be monitored from baseline through up to 46 days for safety and tolerability. Researchers will measure changes in serum uric acid levels, aiming for normalization (≤ 0.36 mmol/L) at 4 weeks. Assessments include laboratory tests, physical exams, and monitoring for adverse effects. Participants must comply with study procedures and provide informed consent throughout the study period.

Researchers are evaluating the safety and effectiveness of different doses of ZL-1102 topical gel, a human VH IL-17A antibody fragment, in adults with chronic plaque psoriasis. This phase 2, randomized, double-blind, vehicle-controlled, dose-ranging study involves about 250 patients with plaque psoriasis affecting 3% to 15% of their body surface area, excluding the head. The study aims to compare various doses of ZL-1102 gel to a placebo gel over a 16-week treatment period. Participants are randomly assigned to one of five groups receiving different doses and frequencies of ZL-1102 gel or placebo gel. The treatment arms include ZL-1102 1% gel applied twice daily, ZL-1102 3% gel applied either once or twice daily, and placebo gel applied once or twice daily. Each participant undergoes 16 weeks of topical treatment with their assigned gel. During the study, participants will be regularly assessed for treatment effectiveness and safety. Researchers will monitor the response to treatment at Week 16, focusing on the comparison of different ZL-1102 doses against placebo. Patient evaluations include clinical examinations, laboratory tests, and safety monitoring. Participants are asked to avoid prolonged sun exposure and tanning devices during the study period. The total study duration for each participant is 16 weeks.

Researchers are evaluating the safety and effectiveness of FB102 in adults aged 18 to 75 years who have non-segmental vitiligo, a skin condition causing loss of pigmentation. This phase 1, randomized, double-blind, placebo-controlled study will include approximately 64 participants who meet the screening criteria. The goal is to compare FB102 to a placebo in managing vitiligo and to monitor any treatment-related side effects. Participants will be randomly assigned to receive either FB102 or a placebo, both administered intravenously. The study treatments will be given under controlled conditions at multiple centers. The trial is designed to carefully observe participants up to 16 weeks after the first dose to assess treatment impact and safety. During the study, participants will undergo various assessments including monitoring for any adverse events and measuring changes in facial vitiligo area using a standardized scoring system. The number of participants experiencing side effects and the percent change in vitiligo area will be tracked throughout the treatment period and up to 16 weeks from the first dose. This close monitoring helps ensure participant safety and provides detailed information on the treatment's effects.

This study is open to adults aged 18 or above legal age with heart failure. People can join the study if they have heart failure symptoms and a left ventricular ejection fraction (LVEF) of 40% or more. The purpose of this study is to find out whether vicadrostat (BI 690517) in combination with empagliflozin helps people with heart failure. Participants are put into 2 groups by chance. Every participant has an equal chance of being in each group. The groups are: * Vicadrostat/empagliflozin group: participants take vicadrostat/empagliflozin as tablets once a day. * Placebo/empagliflozin group: participants take placebo/empagliflozin as tablets once a day. Participants can stay in the study as long as they benefit from treatment and can tolerate it. During this time, they visit their doctors regularly. The doctors regularly check participants' health and take note of any unwanted effects. The study staff may also contact the participants by phone. Participants also regularly answer questions about their well-being. The study does not have a fixed duration. It continues until there is enough data to see if the treatment is working.

Researchers are evaluating the safety and effectiveness of a drug called HB-1 compared to placebo and two other medications in adults aged 18 to 65 years diagnosed with Panic Disorder. This phase 2, multicenter, randomized, double-blind, placebo-controlled trial aims to include approximately 240 to 600 participants, including those with or without certain co-existing conditions, to better understand treatment options for Panic Disorder. Participants will be randomly assigned to receive HB-1, telmisartan, verapamil, or a matched placebo, all provided as tablets. The treatment period lasts 12 weeks, after which a safety follow-up visit will occur one week after the last dose. Throughout the study, patients and researchers will not know which treatment the participants receive to ensure unbiased results. During the trial, participants will be monitored regularly for the number of unexpected panic attacks and any side effects that may arise, with assessments occurring weekly during treatment and at follow-up. Safety evaluations, including laboratory tests and questionnaires, will be conducted at specific intervals to track participants' health and treatment effects throughout the study duration.

Researchers are evaluating the safety and effectiveness of a topical gel called zabalafin for treating people with mild to moderate atopic dermatitis, also known as eczema. This Phase 2b study includes two groups: one with mild to moderate atopic dermatitis and another group with mild to moderate atopic dermatitis plus a secondary skin infection. The goal is to compare zabalafin hydrogel against a placebo (vehicle) over a 16-week treatment period. Participants will be randomly assigned to receive either zabalafin hydrogel or a placebo in a 2:1 ratio. The study includes up to 72 participants across 10 sites in Australia. After up to 2 weeks of screening, participants will apply the assigned gel and visit the study site every 2 weeks for the first month, then monthly until the 16-week treatment ends. This double-blind study means neither participants nor researchers know who receives which treatment. During the study, participants will undergo regular evaluations including a clinical assessment using the validated Investigator's Global Assessment scale (vIGA) to measure treatment effects. Researchers will monitor the severity of eczema, skin lesion size, itching intensity, and any side effects. Participants must follow study procedures, including avoiding other topical products on affected skin areas and attending scheduled visits for up to 113 days.

Researchers are conducting a Phase 2, randomized, double-blind, international multicenter study to assess the safety and effectiveness of ABP-745 in adults experiencing acute gout flares. The study compares ABP-745 with standard colchicine treatment and placebo to evaluate their impact on reducing pain and swelling. The main focus is to measure pain relief after treatment using a visual analog scale. Participants are assigned to one of four groups receiving either two different doses of ABP-745 with colchicine placebo, colchicine with ABP-745 placebo, or double placebo tablets. Treatments are given orally. The study monitors pain changes 24 hours after the first dose. The trial includes adults aged 18 to 70 with a history of gout flares and evaluates responses shortly after flare onset. During the study, participants will undergo assessments including pain scoring to track changes in joint pain. Researchers will monitor safety and treatment effects throughout the treatment period. The total participation timeline includes screening and treatment phases, with attention to medication stability and lifestyle consistency. Pain score changes 24 hours post-treatment serve as the primary outcome measure for evaluating treatment efficacy.

Researchers are evaluating BHV-1300 as a potential treatment for people diagnosed with Graves' Disease. This Phase 1 open-label study aims to assess the safety of BHV-1300 and investigate its effects on biomarkers related specifically to this disease. Participants will receive BHV-1300 through subcutaneous injections. The study does not mention multiple groups or comparator treatments, focusing solely on monitoring participants treated with BHV-1300. During the 52-week study period, researchers will monitor participants for serious adverse events, side effects leading to discontinuation, and any deaths. They will also assess laboratory test abnormalities related to treatment over the same time frame to ensure safety and gather important health data.

Researchers are investigating the safety, effectiveness, and immune response of an Acne mRNA vaccine in adults aged 18 to 45 years who have moderate to severe acne. This Phase I/II trial aims to find the best vaccine dose and regimen by studying up to three intramuscular injections at four different dose levels. Acne is a widespread inflammatory skin condition with significant global impact, and current treatments have changed little in the past 30 years, highlighting the need for new options. The study includes a Core Study and an optional Long-Term Extension (LTE). The Core Study has two groups testing two doses (Cohorts A) and two groups testing three doses (Cohorts B). Participants in Sentinel Cohorts A and B and Main Cohort A may join a 30-month follow-up after their last Core Study visit to evaluate long-term vaccine effects. Those in Main Cohort B can enter a separate LTE study. The vaccine and placebo are given as liquid injections into the muscle. Participants will be monitored closely through various safety assessments, including tracking adverse events shortly after each dose and for several months afterward. Researchers will measure changes in acne lesions at two months post-treatment and follow participants for up to 38 or 40 months in the LTE. Evaluations include medical exams, lab tests, and questionnaires to understand safety, immune response, and how well the vaccine works over time.