Meguro City

Researchers are evaluating the safety and effectiveness of a drug called JX10 compared to a placebo in adults who have suffered an Acute Ischemic Stroke (AIS) and arrive for treatment between 4.5 and 24 hours after symptom onset. The study aims to determine if JX10 improves functional recovery, measured by the modified Rankin Scale, and to assess the risk of symptomatic intracranial hemorrhage associated with the drug. The study has two parts: during Part 1, participants are randomly assigned to receive either JX10 at doses of 1 mg/kg or 3 mg/kg, or a placebo. In Part 2, participants receive the optimal JX10 dose identified in Part 1 or placebo. JX10 is a thrombolytic agent given to help dissolve blood clots causing the stroke. Participants will be monitored for outcomes including the proportion who have no or minimal symptoms 90 days after treatment and the occurrence of symptomatic bleeding within 36 hours after randomization. The study includes clinical assessments, imaging to confirm stroke and salvageable brain tissue, and safety monitoring to evaluate bleeding risks. The trial enrolls adults aged 18 to 90 years with specific stroke characteristics and follows them closely through treatment and recovery.

Researchers are evaluating the safety, effectiveness, and pharmacokinetics of pumitamig (BNT327) combined with chemotherapy and other investigational agents in adults with first-line non-small cell lung cancer (NSCLC). The study includes two substudies based on NSCLC histological subtypes due to differences in chemotherapy treatments. This Phase 2/3, multisite, randomized, open-label trial aims to assess treatments in participants with advanced NSCLC who have not previously received systemic treatment. Each substudy has a Phase 2 part where participants are randomly assigned to one of two doses of pumitamig combined with chemotherapy drugs such as pembrolizumab, carboplatin, pemetrexed, or paclitaxel, given intravenously. The Phase 3 part will include independent data monitoring and blinded central review of tumor scans for all treated participants. The overall planned duration per participant is up to 64 months, covering both study parts and follow-up. Participants will undergo regular tumor assessments and monitoring for safety, including recording treatment-emergent adverse events, dose changes, and serious side effects up to 90 days after the last dose. Effectiveness will be measured by tumor response rates, changes in tumor size, and progression-free survival, with tumor imaging reviewed by a blinded independent committee. This long-term study involves careful evaluation of treatment impact and participant health over approximately five years.

This research observes patients with Paroxysmal Nocturnal Hemoglobinuria who are treated with Fabhalta capsules. It is a multicenter, single-arm, non-interventional study designed to monitor drug use and safety over time. The study uses a central registration and all-case surveillance system to collect data. Participants will be observed for 48 weeks after starting Fabhalta treatment. If treatment stops within this period, any adverse events and use of other medications will be tracked up to 30 days after the last treatment day. There are no additional interventions or comparison groups in this study. During the study, researchers will monitor the occurrence of infections and other adverse events through case report forms. Participants' health and drug usage will be recorded throughout the observation period. The total participation lasts for 48 weeks, focusing on safety and drug use in real-world settings.