Ji Lin Shi

Researchers are investigating the effectiveness, safety, and tolerability of combining baxdrostat with dapagliflozin compared to dapagliflozin alone in people with chronic kidney disease (CKD) and high blood pressure. This Phase III, international, multicenter, double-blind, placebo-controlled study aims to see if this combination reduces risks such as significant kidney function decline, kidney failure, heart failure events, or cardiovascular death. The study includes a 4-week run-in period where participants not previously treated with SGLT2 inhibitors receive dapagliflozin alone. After this, participants are randomly assigned to receive either baxdrostat plus dapagliflozin or placebo plus dapagliflozin in a double-blinded manner. Study visits occur frequently initially (at 2, 4, 8, 16, 34, and 52 weeks after randomization) and then approximately every 4 months. If participants stop the blinded treatment early, they continue dapagliflozin alone unless specific criteria require its discontinuation. Participants will undergo regular assessments including blood pressure monitoring and laboratory tests related to kidney function and cardiovascular health. The primary outcome measures the reduction in risk of major kidney and heart events over up to 37 months. Even if participants stop the study treatment, they will continue follow-up visits and data collection to ensure comprehensive safety and efficacy evaluation throughout the study duration.

Researchers are evaluating the safety and effectiveness of Rocbrutinib compared to the investigator's choice of Bendamustine plus Rituximab (BR) or Rituximab plus Lenalidomide (R2) in adults with relapsed or refractory non-germinal center B-cell-like (non-GCB) Diffuse Large B-Cell Lymphoma (DLBCL). This is an open-label, randomized, multicenter Phase II study focused on patients who have had at least two prior therapies, including one with an anti-CD20 antibody. Participants are randomly assigned to receive either Rocbrutinib alone at a dose of 200 mg once daily by mouth until disease progression or unacceptable side effects, or the investigator's choice of combination therapy. Those in the combination therapy group receive 6 cycles of treatment, each cycle lasting 28 days, with Bendamustine given by IV infusion on days 1 and 2 and Rituximab by IV infusion on day 1 of each cycle, or Lenalidomide at 20 mg daily by mouth on days 1 through 21 of each cycle. During the study, participants will be monitored for their response to treatment for up to 24 months. Researchers will assess overall response rates, safety, and disease progression through regular evaluations. Participants will undergo clinical assessments, imaging, and laboratory tests to track treatment effects and monitor for any side effects throughout the study period.

Researchers are evaluating the safety, tolerability, and effectiveness of valemetostat tosylate combined with DXd antibody-drug conjugates (ADCs) in patients with advanced solid tumors, including HER2-positive gastric cancer, non-squamous non-small cell lung cancer (NSCLC), and unresectable or metastatic HER2 low breast cancer. This Phase 1b study aims to determine the recommended dose for further study and to assess treatment effects in these patient groups. The study has two parts: Part 1 involves dose escalation where valemetostat is given orally once daily, combined with either T-DXd or Dato-DXd administered by intravenous infusion every three weeks on Day 1 of each 21-day cycle. After identifying the recommended dose, Part 2 will expand to further evaluate safety and tolerability of this combination treatment. Participants will undergo regular assessments including imaging scans every 6 weeks during the first year and every 12 weeks thereafter to evaluate tumor response. Safety will be monitored from screening through 40 days after the last dose. Researchers will track adverse events and dose-limiting toxicities during the treatment cycles, which last 21 days each. Follow-up may continue for up to approximately 5 years to observe long-term outcomes.

Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), immune response, and antitumor activity of SKB500 in adults with advanced solid tumors. This is a multicenter, open-label Phase I clinical trial. The study includes a dose-escalation phase, a dose-expansion phase, and an indication-expansion phase to explore different dosing levels and tumor indications. Participants receive SKB500 through intravenous infusion every three weeks (Q3W). The study begins with a dose-escalation phase to find the appropriate dose, followed by dose-expansion and indication-expansion phases to further assess safety and antitumor effects. Treatment continues with scheduled infusions and monitoring during these phases. During the study, participants undergo evaluations to monitor safety, including tracking any adverse events (AEs), serious adverse events (SAEs), treatment-related adverse events (TRAEs), and dose-limiting toxicities (DLTs) especially during the first 21 days of cycle 1. Researchers also collect data on the drug's pharmacokinetic profile and immune response. The study period can last up to three years with ongoing safety and activity assessments.

This clinical trial is a phase II, open-label, multicenter study focused on evaluating the safety and effectiveness of AHB-137 injection in adults aged 18 to 65 who have Chronic Hepatitis B (CHB) and have previously been treated with nucleoside(t)ide analogues (NA). Participants must have been positive for HBsAg or HBV DNA for at least six months and meet specific liver function and medication history requirements. The study aims to assess the impact of AHB-137 on viral markers after treatment discontinuation.

Researchers are evaluating the efficacy of claseprubart (DNTH103) compared to placebo in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) in this Phase 3 study. The goal is to assess how well claseprubart works in treating this condition, which involves nerve inflammation leading to muscle weakness and sensory problems. The study consists of multiple periods: Part A is an open-label phase lasting up to 13 weeks where all participants receive claseprubart. Those who respond move to Part B, a randomized, double-blind, placebo-controlled phase lasting up to 52 weeks, where participants receive either claseprubart or placebo by infusion or injection. After Part B, eligible participants may join an optional open-label extension for up to 104 weeks. A safety follow-up period of 40 weeks follows the treatment phases. Participants will undergo various assessments including neurological evaluations and disease activity scoring. Researchers will monitor the time from the first dose to disease relapse as the main outcome. Additional safety and efficacy measures will be tracked throughout all study periods. Total participation may last over two years including extension and follow-up phases.

Researchers are conducting an open-label, single-arm Phase 2 study to collect safety data on hydronidone capsules in adults with chronic hepatitis B infection accompanied by liver fibrosis or fatty liver disease with fibrosis. This study aims to understand how the drug affects patients with these liver conditions, including those with compensated cirrhosis. Participants will take hydronidone capsules orally three times a day, with three capsules each time, totaling 270 mg daily. The medication is taken half an hour before meals for 28 days. About 200 subjects will receive this treatment, and there is no comparison group in this study. During the study, researchers will monitor for any adverse events occurring within 28 days after drug administration. Participants will undergo assessments related to their liver condition and safety monitoring throughout the treatment period. The study focuses on safety outcomes to better understand the effects of hydronidone in this patient population.

Researchers are evaluating whether the medicine tenecteplase helps adults recover from an acute ischemic stroke when given more than 4.5 hours after they were last seen well. This study focuses on people who had a stroke caused by a clot blocking blood flow in the brain and who have imaging showing brain tissue that can still be saved. Participants should not be planning to receive a procedure to remove the clot and must have a pre-stroke disability level of 0 or 1 on the modified Rankin Scale. Participants are randomly placed into two groups. One group receives a single injection of tenecteplase into a vein, while the other group receives standard medical care. The study includes adults aged 18 and over who had an acute stroke or woke up with stroke symptoms more than 4.5 hours ago. Imaging with MRI or CT is used to confirm eligibility. The study lasts about three months, starting with a hospital stay of about one week. During the study, participants have seven clinical examinations or visits to monitor their recovery and health. The last two visits may be done from home to allow remote assessments. Researchers use the modified Rankin Scale to measure disability or dependence in daily activities at 90 days after treatment. They also monitor for any side effects or health changes to compare the effects of tenecteplase against standard care.

Researchers are evaluating the safety, tolerability, and effectiveness of SHR-4849 injection in people with advanced solid tumors. The study aims to find a reasonable dosage for SHR-4849 in this patient group. This is a Phase I, open-label, multicenter trial focusing on patients with confirmed advanced solid tumors who meet specific health criteria. Participants will receive SHR-4849 as the investigational drug. The study includes a dose escalation phase to determine the maximum tolerated dose or maximum administered dose, followed by a dose expansion phase to confirm the recommended phase 2 dose. The dosing and observation periods last up to 24 months, during which safety and pharmacokinetics will be closely monitored. Throughout the study, participants will undergo assessments for safety events, adverse events, and efficacy measures. The primary outcomes include the incidence of dose-limiting toxicities during a 21-day observation period and overall adverse events monitored up to 24 months. Researchers will also evaluate pharmacokinetics and tolerability, with continuous safety follow-up to ensure participant well-being during the trial.

Researchers are evaluating the pharmacokinetics of insulin degludec and liraglutide combined in a single product compared with Xultophy in healthy Chinese adults aged 18 to 45 years. This phase 1 trial aims to understand how these drugs behave in the body by measuring their concentration over time after a single dose. The study focuses on healthy participants with specified body mass index and weight requirements, without significant health conditions or recent surgeries. Participants will receive a single subcutaneous dose of the insulin degludec/liraglutide combination product containing 0.61 mg liraglutide and 17 U insulin degludec, and will also receive Xultophy in a randomized, open-label, two-period, crossover design. Blood samples will be collected at multiple intervals during two dosing periods to measure drug levels, with a total blood volume of less than 400 mL taken. Some study visits require participants to stay at the trial site overnight, while others are outpatient visits for drug administration and assessments. Throughout the trial, participants will undergo physical exams, vital sign checks, and laboratory tests including blood glucose and hormone levels. Safety monitoring includes screening for allergies, infections, and other health issues. Researchers will measure maximum plasma concentrations and the area under the concentration-time curves for both drugs over specific time frames. Participation lasts through the two dosing periods with follow-up assessments to ensure safety and gather complete pharmacokinetic data.