McGehee

Researchers are evaluating the safety, tolerability, and levels of the study drug SYX-5219 in healthy volunteers and people with moderate to severe atopic dermatitis (AD). This multi-part, Phase 1, first-in-human study includes participants aged 18 to 65 years. The study aims to understand how SYX-5219 behaves in the body and to assess its safety in different dosing scenarios, including single and multiple doses as well as food effects. The study is divided into three parts. Part 1 involves single ascending doses (SAD) and a food effect evaluation in up to 48 healthy volunteers, who receive oral capsules of SYX-5219 or placebo. Part 2 tests multiple ascending doses (MAD) in up to 24 healthy volunteers with multiple oral doses given over a treatment period. Part 3 enrolls up to 45 participants with confirmed active AD to receive SYX-5219 or placebo daily for up to 42 days. This part is conducted at multiple global sites. Participants will undergo safety and exploratory efficacy assessments during treatment and follow-up periods. Researchers will monitor adverse events from the date of consent through various time points depending on the study part, including up to 10 days after dosing in Part 1 and up to 56 days in Part 3. Assessments include laboratory tests, vital signs, ECGs, and clinical evaluations to gather information on safety, tolerability, and drug levels in blood and urine throughout the study duration.

Researchers are evaluating the effects of TAK-330 compared with four-factor prothrombin complex concentrate (4F-PCC) as part of standard treatment for reversing anticoagulation in adults treated with Factor Xa inhibitors who need urgent surgery or invasive procedures. This Phase 3 trial aims to assess the safety and effectiveness of TAK-330 in managing direct oral Factor Xa inhibitor-related coagulopathy in this urgent setting. Participants will be randomly assigned to receive either TAK-330 or the standard care 4F-PCC before their surgery. TAK-330 is given as a single intravenous infusion of 25 IU/kg on Day 1, with a possible additional dose if needed. The standard 4F-PCC dosing and infusion speed follow local protocols, with an option for an extra dose not exceeding 50 IU/kg or 5,000 IU during surgery if required. During the study, participants will be hospitalized for surgery and monitored closely. Researchers will assess the effectiveness of stopping bleeding during surgery and follow up with participants by telehealth or phone call 30 days after surgery. The study will track safety and hemostasis to understand the impact of the treatments on bleeding control and patient outcomes.