Pukekohe

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating the safety, tolerability, immunogenicity, pharmacokinetics (PK), and pharmacodynamics (PD) of HS-20118 in healthy adults and patients with moderate to severe plaque psoriasis. This Phase 1 trial is divided into two parts: a single ascending dose (SAD) study in healthy participants and a multiple ascending dose (MAD) study in patients with psoriasis. The study aims to understand how the drug behaves in the body and its effects after single and multiple doses. Part 1 (SAD) is a single-center, randomized, double-blind, placebo-controlled study involving five dose cohorts, each including 12 healthy participants receiving either HS-20118 or placebo orally. Part 2 (MAD) is a multi-center, randomized, double-blind, placebo-controlled study with six dose cohorts of patients with moderate to severe plaque psoriasis, each cohort also including 12 participants receiving multiple oral doses of HS-20118 or placebo. Both parts include blood sampling for pharmacokinetic, immunogenicity, and pharmacodynamic assessments along with safety evaluations. Participants will undergo various examinations including physical exams, vital signs monitoring, laboratory tests, electrocardiograms, and imaging where applicable. Safety is closely monitored by tracking adverse events and clinical abnormalities throughout the study periods (up to 36 days for SAD and 71 days for MAD). Blood samples will be collected for drug level measurements and immune response evaluation. The total duration and follow-up details are aligned with the dosing schedules in each study part.

Researchers are evaluating the safety, pharmacokinetics, and pharmacodynamics of TRB-061, a drug given by subcutaneous injection, in healthy adults and patients with moderate-to-severe atopic dermatitis (AD). This Phase 1a/1b randomized, double-blind, placebo-controlled study includes multiple parts to assess single and multiple doses. The study may adjust the number of dosing groups in the first two parts based on ongoing results. In Part 1, healthy adults receive a single dose of TRB-061 or placebo, followed by 12 weeks of monitoring. In Part 2, healthy adults receive three doses every four weeks over eight weeks, with a 10-week follow-up. Part 3 involves participants with moderate-to-severe AD receiving four doses of TRB-061 or placebo over 12 weeks, followed by a follow-up period. After the main study, those on placebo may have the option to receive the active treatment. Participants will undergo regular safety assessments including medical history, physical exams, laboratory tests, and monitoring for adverse events from screening through follow-up. Researchers will measure the incidence of adverse events and serious adverse events across all parts of the study. The total participation duration varies by part but includes follow-up lasting up to 12 weeks after dosing to ensure safety and collect pharmacological data.