Christchurch

Researchers are evaluating molnupiravir, an oral medicine designed to stop the COVID-19 virus from multiplying, to see if it can prevent severe illness from COVID-19 in people at high risk of disease progression. The study focuses on adults with confirmed COVID-19 infection who are at increased risk due to age, medical conditions, or other factors. This is a Phase 3 randomized, placebo-controlled, double-blind clinical trial led by Merck Sharp & Dohme LLC. Participants will be randomly assigned to receive either molnupiravir or a matching placebo. Those in the molnupiravir group will take 800 mg orally every 12 hours for 5 days, totaling 10 doses. The same dosing schedule applies to the placebo group. Some participants may also receive remdesivir as part of standard care if clinically appropriate. During the study, participants will be monitored for up to 29 days to assess outcomes such as hospitalization, death, or medically attended visits related to COVID-19. Safety will be evaluated by tracking adverse events and discontinuation due to side effects. Researchers will also measure symptom relief, viral RNA levels, and other health indicators. The study is expected to continue until January 2031.

Researchers are evaluating the safety and effectiveness of a once-daily oral medication called AP1189, at a dose of 100 mg, compared to a placebo in participants who have respiratory insufficiency expected to be caused by respiratory viral infections such as SARS-CoV-2, Influenza A or B, or RSV. This study is a Phase 2, randomized, double-blind, placebo-controlled trial aiming to include 96 hospitalized participants. The goal is to assess AP1189 as an add-on treatment to the standard care provided for these respiratory infections. Participants will be randomly assigned in equal numbers to receive either AP1189 tablets or matching placebo tablets once daily for 14 days, alongside their standard of care treatment. The study monitors participants during this 14-day treatment period to evaluate treatment outcomes and safety. During the study, participants will be assessed for a composite outcome including death, need for invasive mechanical ventilation or ECMO, cardiovascular organ support, or new renal failure within 28 days. The study includes clinical evaluations, oxygen saturation measurements, and safety monitoring during and after treatment. Overall participation lasts at least 28 days to capture these outcomes and monitor participant health.

This trial evaluates the safety, pharmacokinetics, and pharmacodynamics of the drug RO7875913 in healthy adult volunteers aged 18 to 65 years. The study is designed as a Phase I dose-escalation trial to understand how the drug behaves in the body and its potential effects, involving both RO7875913 and placebo treatments. Participants are healthy individuals without major medical conditions, providing a controlled setting to assess the investigational drug. Participants are randomly assigned to receive either RO7875913 or a placebo in a sequential dose-escalation manner. The study uses quadruple masking to ensure unbiased assessment. Dosage and administration schedules follow the protocol, with detailed monitoring of drug concentration and immune response markers during treatment. This study includes a period of up to approximately three months for safety and pharmacodynamic evaluations. Throughout the trial, participants undergo assessments including monitoring for adverse events, blood tests to measure drug levels and antibody responses, and pharmacodynamic marker evaluations. Researchers closely track safety outcomes and determine recommended doses for future studies. Participation involves regular visits for dosing and evaluations, lasting up to three months in total, ensuring careful observation of participants health and response to the study drug.

Researchers are evaluating ARO-ALK7, a drug given by injection, in adult participants with obesity, both with and without Type 2 Diabetes Mellitus T2DM. This Phase 12a study aims to understand the safety, tolerability, how the body processes the drug, and how the drug affects the body. The study is divided into two parts Part 1 focuses on adults with obesity without T2DM, and Part 2 includes adults with obesity both with and without T2DM, testing ARO-ALK7 alone or combined with tirzepatide. Participants receive either single or multiple doses of ARO-ALK7 or matching placebo injections. In Part 2, some participants also receive weekly tirzepatide starting from Day 15 through Day 253. The doses of ARO-ALK7 are escalated to explore different levels of the drug. The study compares ARO-ALK7 alone, placebo, ARO-ALK7 combined with tirzepatide, and placebo combined with tirzepatide to assess their effects. During the study, participants are monitored for treatment-emergent adverse events until Day 253. Researchers collect detailed information on how the drug moves and acts in the body, especially during Part 1. Participants will have scheduled visits to receive treatments and undergo safety and effectiveness assessments. The total study duration covers up to about 8 and a half months, including dosing and follow-up, to fully evaluate the drugs impact and safety profile.

Researchers are studying ARO-INHBE, a drug administered by subcutaneous injection, in adults with obesity, with and without type 2 diabetes. This Phase 12a trial evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple doses of ARO-INHBE. The study includes participants with obesity, defined by a body mass index between 30 and 50 kgm, and those with type 2 diabetes mellitus meeting specific criteria. The study phases explore different dosing regimens and combinations with tirzepatide. The trial has three parts Part 1 assesses single and multiple ascending doses of ARO-INHBE or placebo. Part 2 and Part 3 evaluate multiple doses of ARO-INHBE alone or combined with weekly tirzepatide injections at set dosages, or matching placebos, over periods ranging up to 365 days. Dosing schedules vary by study part and include injections on specific days such as Day 1, 29, 85, 169, 253, and weekly tirzepatide from Day 15 onwards. Participants will undergo regular assessments including monitoring for treatment-emergent adverse events up to Day 365. Pharmacokinetic measurements such as plasma concentration and clearance of ARO-INHBE are taken at various timepoints. Participants are expected to adhere to stable diet and exercise routines and comply with study visits and procedures throughout the study duration. Safety and drug activity are carefully evaluated during and after treatment periods.

Researchers are conducting a first-in-human, multi-center clinical trial to study the effects of SRP-1005 in people with Huntingtons disease HD. The trial is designed to evaluate the safety and impact of SRP-1005, a drug given by subcutaneous injection, compared to a placebo. The study includes adult participants aged 21 to 70 years who have a genetically confirmed diagnosis of HD and are at specific disease stages. Participants will be randomly assigned to one of four groups receiving different doses of SRP-1005 or a placebo. The study is double-blind, meaning neither the participants nor the researchers know who receives the drug or placebo. The treatment period includes dose escalation and monitoring to assess the drugs presence in plasma, urine, and cerebrospinal fluid over several weeks. During the study, participants will be monitored for side effects and adverse events from baseline through 24 weeks. Researchers will collect blood, urine, and cerebrospinal fluid samples to measure drug levels and safety. Participants must agree to use effective contraception if applicable, and the study excludes those with certain infections, other neurological illnesses, or conditions that prevent safe lumbar puncture or MRI. The total participation lasts at least 24 weeks with ongoing safety assessments.

Researchers are evaluating the safety, tolerability, pharmacokinetics how the drug moves through the body, and pharmacodynamics the drugs effects on the body of GRT7041 in healthy adult men and women who are not capable of childbearing. This Phase 1 trial aims to better understand how GRT7041 behaves in the body and its safety profile. The study is sponsored by Grnenthal GmbH and includes healthy volunteers aged 18 to 60 years. The trial has two parts. Part 1 involves single ascending doses SAD of GRT7041 in up to five groups, including adult males and women of non-childbearing potential, with dosing mainly under fasting conditions except for one group assessing the effect of food on drug absorption. Part 2 involves multiple ascending doses MAD given once daily for 14 days to adult males only, also under fasting conditions. The study also examines how GRT7041 interacts with another drug called midazolam in Part 2. Participants will undergo a screening visit, stay in the study facility during treatment periods, and attend follow-up or end-of-trial visits. Researchers will monitor adverse events, conduct physical exams, ECGs, vital signs, laboratory tests, and measure drug levels in the blood over time. The total duration for participants is up to approximately 6 to 8 weeks for Part 1 and up to 7 weeks for Part 2, including treatment and observation periods to evaluate safety and drug behavior in the body.

This research aims to evaluate elafibranor, a study drug, compared to a placebo in adults with Primary Biliary Cholangitis PBC and cirrhosis, a liver disease causing bile duct damage and scarring. The trial focuses on whether elafibranor can better prevent worsening of the disease, including progression leading to liver transplant or death, and also assesses long-term safety and symptom impact such as itching and tiredness. Participants will be randomly assigned to take either an 80 mg tablet of elafibranor or a matching placebo tablet once daily, orally, with or without food. This double-blind treatment period can last up to 3.5 years for each participant, with tablets taken at approximately the same time each morning. The study is designed to compare these two groups over the long term. During the study, participants will undergo regular assessments including physical exams, vital signs, electrocardiograms, laboratory tests, and symptom questionnaires at intervals up to 3.5 years. Researchers will measure liver function tests, symptom scales, liver stiffness, and clinical outcomes related to disease progression. Safety is monitored through adverse event tracking and laboratory parameters, with follow-up extending to four weeks after the last dose. Overall participation may last up to 3.5 years.

Researchers are conducting a Phase 1 randomized, double-blind trial to compare the pharmacokinetics, immune response, safety, and tolerability of two drugs, Bmab3000 and Herceptin Hylecta, after a single subcutaneous injection. This study involves healthy male volunteers aged 18 to 65 years with specific weight and health criteria. The goal is to evaluate how the body processes these treatments and monitor any immune reactions or side effects. Participants will be randomly assigned to receive a single 600 mg subcutaneous dose of either Bmab3000 or Herceptin Hylecta, both containing trastuzumab and hyaluronidase. The study includes two groups of 75 participants each, stratified by body weight. The treatment is given once during an inpatient stay lasting four days, followed by multiple outpatient visits for ongoing monitoring. Volunteers will be involved in the study for about four months, starting with a screening visit to confirm eligibility. After the injection, participants will stay in the clinic for three nights with continuous safety checks including vital signs, ECGs, and blood sampling. Follow-up visits will continue until Day 91 to assess pharmacokinetics, immune response, and safety. The research team will perform physical exams, heart function tests, and laboratory evaluations throughout the study to ensure participant well-being and collect data on the drugs effects.

Researchers are evaluating the safety, tolerability, how the body processes pharmacokinetics, how the body responds pharmacodynamics, and effectiveness of TERN-701, a selective inhibitor targeting BCR-ABL1, in adults with chronic phase chronic myeloid leukemia who have received prior treatment. This Phase 12 trial focuses on participants with treatment challenges such as resistance or intolerance to previous therapies. The study is sponsored by Terns, Inc. and aims to better understand TERN-701s impact in this patient group. The trial has two main parts. Part 1 involves dose escalation where participants receive increasing doses of TERN-701 once daily to determine safe and effective dose levels. Part 2 includes randomized dose expansion cohorts to further assess safety and efficacy at two selected doses from Part 1, and an additional mutation cohort Part 2m evaluating a specific 500 mg dose in participants with certain resistance mutations. Treatment is given continuously in 28-day cycles with scheduled clinic visits at specified days during the first cycle and then on Day 1 of subsequent cycles. Participants will be closely monitored through regular visits for safety, tolerability, and response to treatment. Researchers will evaluate dose-limiting toxicities, adverse events, hematologic and molecular responses, and changes in BCR-ABL1 transcript levels over up to three years. Approximately 180 participants are expected to enroll, contributing to comprehensive data collection on TERN-701s performance and safety in this chronic leukemia population.