Pukekohe

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are conducting a randomized, double-blinded, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, immunogenicity, and exploratory clinical activity of BBT002. This study includes healthy adults and patients with chronic obstructive pulmonary disease COPD or chronic rhinosinusitis with nasal polyps CRSwNP. BBT002 is being developed as a potential treatment for these conditions and is administered via intravenous or subcutaneous injection. The study involves several parts where participants receive either single or multiple doses of BBT002 or placebo. Healthy volunteers receive both single and multiple doses, while patients with COPD or CRSwNP receive multiple doses. The study is designed with a sequential model and includes multiple treatment arms comparing BBT002 to placebo across these groups. Participants will undergo safety and lab assessments including monitoring for adverse events, vital signs, physical examinations, ECG readings, and laboratory tests for up to 141 to 169 days after the first dose depending on the study part. Pharmacokinetic parameters and immunogenicity through anti-drug antibody development will be evaluated at specified timepoints. The total duration includes follow-up periods to monitor safety and treatment effects.

Researchers are evaluating the safety, tolerability, immune response, and how the body processes HS-20118 in adults. This study has two parts Part 1 involves healthy adults receiving a single oral dose, while Part 2 involves patients with moderate to severe plaque psoriasis receiving multiple oral doses. The study is randomized, double-blind, and placebo-controlled to compare HS-20118 with a matching placebo. Part 1 includes five dose groups with 12 participants each, receiving single ascending doses of HS-20118 or placebo. Part 2 includes six dose groups with 12 participants each, receiving multiple ascending doses of HS-20118 or placebo. Both parts involve blood sampling for pharmacokinetics, immune response, and pharmacodynamics, along with safety examinations. Participants will undergo physical exams, vital sign checks, laboratory tests, ECGs, and blood sampling at specified times. Researchers will monitor adverse events, drug levels, immune reactions, and skin condition improvements using scales like PASI and IGA. The study lasts up to 71 days in the multiple dose part, with detailed safety and effectiveness evaluations throughout.

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 1a1b randomized, double-blind, placebo-controlled study includes healthy participants and those with AD to better understand how TRB-061 behaves in the body and its effects. The study is divided into three parts to assess single and multiple doses in different groups. In Part 1, healthy participants receive a single ascending dose of TRB-061 or placebo and are followed for 12 weeks. Part 2 involves healthy participants receiving three doses of TRB-061 or placebo every four weeks over eight weeks, followed by a 10-week follow-up. Part 3 includes patients with moderate-to-severe AD randomized to receive either one of two doses of TRB-061 or placebo every four weeks for 12 weeks. Participants in Part 3 may opt into a crossover period where treatment assignments are switched for another 12 weeks, followed by a final follow-up until the end of the study. Participants will undergo safety assessments including monitoring of adverse events, pharmacokinetic blood tests, and clinical evaluations throughout the study and follow-up periods. Healthy participants are screened for general health and ECG abnormalities before enrollment, while AD patients must have a confirmed diagnosis and moderate-to-severe disease. Regular visits are scheduled for dosing and evaluations, and researchers will measure safety outcomes primarily by tracking adverse events from screening through follow-up. The study aims to complete by February 2028.

Researchers are evaluating the effects of DONQ52 on small intestinal damage and celiac-related symptoms caused by gluten exposure in people with celiac disease who are trying to maintain a gluten-free diet. This Phase II study aims to compare the investigational drug DONQ52 to a placebo in participants with ongoing duodenal damage and persistent symptoms despite adhering to a gluten-free diet. The study focuses on patients with active celiac disease confirmed by specific genetic markers and clinical history. Participants are randomly assigned to receive either DONQ52 or a placebo, both given as subcutaneous injections according to protocol, along with oral Simulated Inadvertent Gluten Exposure SIGE capsules to mimic accidental gluten intake. The study period includes treatment and observation phases, with participants maintaining their gluten-free diet throughout. The treatment is administered over several weeks, and participants undergo two upper gastrointestinal endoscopies with duodenal biopsies to assess intestinal damage. During the study, participants will have regular evaluations including symptom diaries focusing on gastrointestinal symptoms such as abdominal pain, diarrhea, nausea, and bloating. Laboratory tests will monitor drug levels, immune response, and safety. The main outcome measured is the change in the villous height to crypt depth ratio in the intestines over 27 weeks. Safety and side effects will be tracked up to 47 weeks. Participants will also be monitored for antibodies against DONQ52 and overall symptom changes over the course of the study.