ANZCTR search results

This is a phase I, randomized, double-blinded, placebo-controlled, single and multiple dose escalation study to evaluate the safety, tolerability, pharmacokinetic characteristics and pharmacodynamics of HX15001 in adult healthy participants. The study consists of two parts: Part A involves single-dose escalation (Cohorts 1-7), and Part B involves multiple-dose escalation (Cohorts 8-9). The primary objective of this study is to characterize the safety and tolerability of single and multiple doses of HX15001 in healthy subjects.

The purpose of this research is to evaluate a new investigational device for the diagnosis of stroke, the EMVision emu™ Brain Scanner. Stroke is the result of a blood clot stopping the normal flow of blood in the brain (ischaemic stroke) or a breakage in a blood vessel causing bleeding in the brain (haemorrhagic stroke). Stroke is a medical emergency and must be quickly diagnosed and treated. Computed tomography (CT) or magnetic resonance imaging (MRI) scans are commonly used to diagnose stroke, but they are not always readily available. EMVision has developed the emu™ Brain Scanner, a helmet-like device which scans the head using ultra-high frequency radio signals. It is portable and easy to use, making it more accessible than CT or MRI machines. Easier access to the EMVision emu™ Brain Scanner may reduce the time taken to diagnose stroke, leading to faster treatment and better health outcomes. It is the purpose of this study in the first instance to determine the accuracy of the EMVision emu™ Brain Scanner in the detection of haemorrhagic stroke.

This study is designed to demonstrate the efficacy and assess safety and tolerability of oral daily alpelisib in participants with PIK3CA-related overgrowth spectrum (PROS).

Researchers are looking for other ways to treat locally advanced or metastatic colorectal cancer (mCRC) that is unresectable and has a gene mutation called KRAS G12C. Standard (or usual) treatments for this type of colorectal cancer may include mFOLFOX6 with or without bevacizumab. Researchers want to learn if adding calderasib (the study medicine) and cetuximab to mFOLFOX6 can treat locally advanced or mCRC with the KRAS G12C mutation. Calderasib and cetuximab are targeted therapies. The goals of this study are to learn: * About the safety of calderasib with cetuximab and mFOLFOX6 and if people tolerate the treatments * If people who receive calderasib with cetuximab and mFOLFOX6 live longer without mCRC growing or spreading compared to people who receive mFOLFOX6 with or without bevacizumab.

Phase 2 Study of TYRA-300 in FGFR3 Altered Low Grade, Intermediate Risk NMIBC

The study is an open-label, single arm, multicenter, Phase III study to determine proteinuria reduction, pharmacokinetics (PK), safety and tolerability (including CV surveillance) of iptacopan in primary immunoglobulin A nephropathy (IgAN) pediatric patients aged 2 to \<18 years.

Respiratory syncytial virus (RSV) is a leading cause of hospitalizations for acute lower respiratory tract infection (LRTI) in infants. In Australia approximately 1.5% of infants are hospitalized due to RSV, 80% of whom are born full-term and are otherwise healthy. Two randomized trials have used a seasonal implementation strategy to show nirsevimab, a long-acting monoclonal antibody, has sustained efficacy against RSV LRTI hospitalizations in the first 150-180 days after administration. Nirsevimab has been approved in many countries for the prevention of RSV-LRTI in neonates and infants. However, the protection offered by nirsevimab beyond 180 days remains unknown. Queensland is a large Australian state spanning the tropical and sub-tropical climate zones, where RSV circulates year-round. The Queensland government publicly funded nirsevimab for all infants at birth from 15 April 2024. The aim of this study is to estimate the duration of effectiveness of nirsevimab against RSV-related hospitalizations. A case-control study will be conducted using routinely collected linked data. Cases will be children born in Queensland from 15 April 2024 to 14 April 2025 who are hospitalised with an RSV-related condition prior to 14 April 2026. Controls will be drawn from the set of infants who are admitted to the same hospital in a 5:1 ratio, and matched on age and sex using the Queensland Perinatal Data Collection. Nirsevimab receipt will be extracted from hospital's electronic medical records and linked to hospitalization data by the Queensland Health Data Linkage Unit. Duration of protection against RSV-related hospitalisation due to nirsevimab will be assessed using multivariable logistic regression model accounting for matching and adjusting for confounding variables. This case-control study will determine the level and duration of protection offered by nirsevimab in a region with year-round RSV circulation and inform future prevention strategies. Interim analysis is expected to be available at the time of the conference, allowing for early dissemination of this first evidence about nirsevimab duration of protection beyond 180 days. Funding: From Sanofi and AstraZeneca through a collaboration grant.

PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in pregnancy reduces the proportion of infants who are admitted to a neonatal unit for management of hypoglycemia compared with current standard hospital care. The trial will also assess other important outcomes including breastfeeding rates, maternal mental health, and infant cow's milk allergy. There will be two treatment arms. In the intervention arm, PDHM will be made available to infants from randomisation until day 5 of life. Infants allocated to the control arm will receive care as per local unit policy, including supplemental nutrition as recommended by the treating clinician. After hospital discharge, participants will be asked to complete an electronic questionnaire at 2 \& 6 weeks and 6 \& 12 months after birth. Questionnaires will assess infant feeding practices, maternal quality of life \[including anxiety and depression symptoms and health-related quality of life\] along with infant cow's milk allergy symptoms.

This aim of this study is to further develop a new way to study the bacteria that causes pharyngitis (strep throat). The scientific name for this bacterium is Streptococcus pyogenes and it is commonly known as Strep A. Strep A is a common type of bacteria that can cause various infections. These range from skin infections and strep throat to more serious conditions like rheumatic heart disease. In recent years there has been an increase in severe Strep A infections in most countries. Many of these cases have been reported in the news. Human challenge models are studies which allow researchers to study organisms that cause infections in humans. In this human challenge model study, healthy participants will be carefully exposed to a specific type of Strep A under controlled conditions to cause sore throat and learn more about how Strep A causes infection. The study team has already developed a safe human challenge model using a strain of Strep A called M75. This study will use a different strain of Strep A, called M1. The main goal of this study is to check if the procedure is safe for participants and to understand how the participant's body responds to M1 Strep A. The study will explore: 1. How much M1 Strep A is required to cause an infection. 2. How M1 Strep A grows in the body. 3. How the body reacts to M1 Strep A. The information the investigators will get about M1 Strep A from this study will help plan future research. It may also help in designing better studies to test vaccines against Strep A.

This Phase II study aims to evaluate efficacy and safety of the combination of JSB462 (also known as luxdegalutamide) at 100 mg and 300 mg once a day (QD) doses + abiraterone compared with an androgen receptor pathway inhibitor (ARPI, abiraterone or enzalutamide) in participants with metastatic Hormone Sensitive Prostate Cancer (mHSPC) and to select the recommended dose of the combination for phase III. Towards that end, the totality of the efficacy, safety, tolerability and PK data from participants randomized in the study will be evaluated