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 primary objective of this study is to characterize the pharmacokinetics (PK) profile of a single dose of AMG 592 administered subcutaneously in healthy Japanese participants.
The goal is to expand a parent-mediated intervention for feeding challenges in children with autism with an Australian cohort, building on recent research and current successful models already being used. A parent-mediated intervention would primarily occur in the home environment, working with the parent to establish goals and implement the intervention based on their child's specific needs.
The goal of this clinical trial is to evaluate the safety, tolerability, and pharmacokinetics of BRII-297 in healthy adult subjects. The main aim of the study is to evaluate the safety and tolerability after single dose intramuscular administration of BRII-297. The study also aims at characterizing the PK profiles of BRII-297 and brexanolone after single dose intramuscular administration. Participants will be enrolled in 6 cohorts (3 planned and 3 optional) with 6 participants per cohort [(4 active: 2 placebo) - Cohorts 1 & 2] and 10 participants per cohort [(8 active: 2 placebo) - Cohorts 3 to 6]. Randomization for each cohort will be a two-step process. Sentinel subjects for each cohort will include 2 female subjects randomized 1:1 to BRII-297 or placebo who will be observed for at least 24 hours to ensure no significant safety events before administering study drug to the remaining non-sentinel subjects. The estimated total duration for each subject is up to 43 days, including screening period (28 days), dosing period (1 day), and post-dose follow-up period (14 days). IM injections will be administered in the gluteal muscle. Each participant in all cohorts will begin their inpatient stay at the clinical investigational site on Day -1 and remain as an inpatient at the site for sample collection and assessments for 15 days post dose (Day 15). Participants will be released at the end of the inpatient period.
This is a Phase I, Single-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Tolerability of ILB-202 Administered Intravenously as Single Ascending Doses to Healthy Participants. Male or female subjects aged 18 to 50 years (inclusive) who fulfill the inclusion/exclusion criteria will be enrolled in this study.
This is a Phase 1, parallel, randomized, active-controlled, multi-center, dose-esclation study with a Master Protocol design which will include several substudies that are developed to evaluate the safety and immunogenicity of different dose levels of modified messenger ribonucleic acid (mRNA) vaccines encoding full length hemagglutinin (HA) sequence of influenza virus encapsulated in lipid nanoparticles (LNPs) (hereafter referred to as HA mRNA vaccines) compared to control(s). The HA mRNA vaccine candidates and control(s) are presented in the substudy protocols. The aim is to generate clinical data across different substudies to provide learnings regarding the mRNA technology to support optimization of the mRNA platform including mRNA and LNP design and to support the decision of LNP and dose selection for future projects using mRNA technology. The purpose of this Substudy 01 is to evaluate the safety and immunogenicity of a single IM injection of up to 5 dose levels of a monovalent modified mRNA encoding the full-length HA sequence of A/Tasmania/503/2020 (H3N2) influenza virus encapsulated in LNP (hereafter referred to as H3 mRNA /LNP) administered as a single intramuscular (IM) injection in adults 18 to 49 years of age and 60 years of age and above, compared to the following active control: a quadrivalent recombinant influenza vaccine (RIV4).
This study was a retrospective, non-interventional, longitudinal, descriptive study. This study did not have a key underlying hypothesis, rather it was designed to explore the onboarding and adherence of SPMS patients in Australia to Mayzent (siponimod) treatment. Initiating siponimod involves pre-screen tests, including a CYP2C9 genotype test to determine siponimod maintenance dosing, and patients underwent a 6-day titration prior to maintenance. The MSGo platform was developed to support onboarding. It is an integrated digital platform that functions as a patient support service.
This is a double-blind randomised placebo-controlled trial to evaluate orally-dosed food-grown magnesium compared to placebo on improvement in sleep quality and quantity as well as quality of life in otherwise healthy participants aged 18 years and older.
The primary goal of this study is to use qualitative interviews to elicit and confirm concepts related to treatment preferences and understandability of the pTPMQ, cTPMQ, and mTPMQ. The information gathered will be used to support the appropriateness of the questionnaires as a patient-reported, caregiver-reported and clinician-reported outcome measure (PROM) in the population of interest.
The goal of this clinical trial is to learn about the potential effect of ENV-101 (taladegib) on the pharmacokinetics of nintedanib (an approved treatment for idiopathic pulmonary fibrosis) when the two compounds are dosed together in healthy subjects. Participants in this study will receive ENV-101 and/or nintedanib on various days throughout a 10-day period during which they will reside at the clinical trial site.
The goal of this clinical trial is to test the ATH-063 drug (single and multiple doses) in Healthy Subjects. The clinical trial aims to evaluate the below. 1. Safety of the drug 2. Tolerability of the drug 3. Pharmacokinetics (PK) (how the human body affects the drug) 4. Pharmacodynamics (PD) (how the drug affects the human body) This will be a single center, Phase 1, First-In-Human, Randomized, Double-Blind (neither the subjects nor the experimenters know which subjects are in the test and control groups), Placebo (a look-alike substance that contains no active drug) - Controlled Study.