There are about 10460 clinical studies being (or have been) conducted in Australia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
The main goal of this first in human (FIH) study is to learn about the safety and dosing of GS-9911 when given alone or in combination with an anti-programmed cell death protein 1 (PD-1) monoclonal antibody in participants with advanced solid tumors. The primary objectives of this study are to: - Assess the safety and tolerability of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors - Identify the maximum tolerated dose (MTD)/maximum administered dose (MAD) and the recommended dose for expansion (RDE) of GS-9911 as monotherapy and in combination with an anti-PD-1 monoclonal antibody in participants with advanced solid tumors
FOCUS is a dyadic, psychoeducational intervention developed in the USA, shown to improve the wellbeing and quality of life (QoL) of patients with advanced cancer and their primary family carers. The intervention consists of five core components underpinning the FOCUS acronym: (F) supporting Family involvement, (O) supporting Outlook and meaning, (C) increasing Coping effectiveness, (U) reducing Uncertainty, and (S) Symptom management. Originally a nurse-delivered in-person intervention, FOCUS has been translated into a self-administered web-based intervention as part of an European study. The overall aim of this project is to determine the effectiveness and sustainability of a digital health intervention (FOCUSau) aimed at improving the wellbeing and self-efficacy of patients with advanced cancer and their primary support person/carer. A primary support person/carer is an unpaid individual identified by the person with advanced cancer (not necessarily a partner or family member) who is providing them with physical, social or emotional support. Hereafter referred to as a "carer". The term "dyad" refers to the patient and primary support person/carer. The project objectives are: 1. adapt FOCUS to the Australian context and develop FOCUSau; 2. examine the effectiveness of FOCUSau in improving the wellbeing (primary outcomes: QoL and self-efficacy) of patients with advanced cancer and their primary family carer; 3. compare the type and costs of health service use by participants in the intervention and control group; and 4. assess the acceptability, feasibility and scalability of FOCUSau in order to inform sustainable implementation of the intervention within the Australian health care system. A pragmatic phase III hybrid effectiveness-implementation trial with an integrated research design that includes digital health evaluation will be used in patients with advanced cancer and their primary support person/carer. Data will be collected three times from patient-carer dyads: 1. at baseline (T0) after which the dyad will immediately be randomised to one of the study arms, 2. first follow-up at 12 weeks after baseline (T1) and, 3. second follow-up at 24 weeks after baseline (T2).
This is a randomized, double-blind, placebo-controlled phase I study to evaluate the safety, tolerability and PK profiles of orally administered VG290131 in healthy subjects. The main questions it aims to answer are: 1. The safety and tolerability of VG290131 when administered orally as a single dose and multiple doses in healthy subjects. 2. The pharmacokinetic (PK) profiles of VG290131 and the food effect on the PK profiles of VG290131 in healthy subjects. Approximately 86 subjects will be enrolled in the study.
This is a study evaluating the safety and efficacy of bomedemstat (MK-3543) compared with the best available therapy (BAT) in participants with essential thrombocythemia (ET) who have an inadequate response to or are intolerant of hydroxyurea. The primary study hypothesis is that bomedemstat is superior to the best available therapy with respect to durable clinicohematologic response (DCHR).
A Phase 1, Open-Label, Drug-drug Interaction, and Randomized, Double-blind, Controlled, Multiple-dose Pharmacokinetics and Safety Study of Xeruborbactam Oral Prodrug (QPX7831) in Combination with Ceftibuten in Healthy Adult Participants
This trial is a Phase 2, multicenter, double-blind, randomized (ratio 2:1 TransCon CNP vs. placebo), placebo-controlled trial, designed to evaluate the safety, tolerability, and efficacy of 100 μg CNP/kg of Navepegritide (TransCon CNP) administered SC once-weekly for 52 weeks in infants with genetically verified heterozygous ACH, aged 0 to < 2 years at the time of randomization.
The primary purpose of this study is to assess the safety and tolerability of ALXN1850 versus asfotase alfa in pediatric participants with HPP previously treated with asfotase alfa.
The primary purpose of this study is to evaluate the efficacy of ALXN1850 versus placebo on radiographic outcomes in pediatric participants with HPP who have not previously been treated with asfotase alfa.
The primary objective of this study is to assess the efficacy of ALXN1850 versus placebo on functional outcomes in adolescent and adult participants with HPP who have not previously been treated with asfotase alfa.
The aim of this study is to assess the efficacy and safety of GSK4527226 in participants with early Alzheimer's Disease (AD) (including mild cognitive impairment [MCI] and mild dementia due to AD) of 2 dose levels of GSK4527226 compared to placebo.