ANZCTR search results

This study is for the evaluation of the safety, tolerability, PK, PD, and biomarker activity of GIM-407 in healthy volunteers in the absence of any disease-related or potentially confounding factors.

A randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study to assess the safety, tolerability, and PK of single and multiple ascending doses of MTX-474 administered in healthy adults.

Abstract: A lack of exercise combined with low levels of activity is prominent in people with Mitochondrial Disease (MD). Unfortunately, access to health professionals such as physiotherapists with experience in MD is difficult, especially in remote areas. The use of digital health technology (DHT) may be a feasible and acceptable way to remove access barriers while increasing participant compliance and self-efficacy with exercise. Given that the implementation of DHT to improve exercise compliance is scalable and inexpensive, it's important to test this intervention clinically. Objective: To determine the feasibility and acceptability of a structured home exercise program, supported by DHT, in people with MD. Methodology: Ten to 15 participants from the MD clinic at Neuroscience Research Australia will be recruited for this study. All participants will be remotely monitored for 8-weeks, provided with a customised, structured home exercise program and activity monitor smart watch. Training volume will increase gradually. Participants will receive weekly, individualised emails supporting their exercise program, weekly telehealth coaching sessions and pre-programmed smart watch movement reminders. Physical performance measures will be taken at week 0, pre-intervention and week 9, post-intervention. Questionnaires on fatigue, quality of life and acceptability of the program will also be administered. Results: Feasibility will be determined from the percentage of participants who enrol in the study from the eligible pool, percentage of dropouts over the study duration, and the percentage who adhere to the exercise program (defined as completing =75% of the regimen). Acceptability outcomes will be extracted from post-program questionnaires. Descriptive statistics of outcome measures (means and standard deviations) and any changes from pre to post will also be calculated. Conclusion: If shown to be feasible and acceptable, this intervention has the potential to deliver a significant impact on the lives of individuals with MD and the wider MD community.

The main purpose of the study is to evaluate the efficacy of adjuvant treatment with autogene cevumeran plus nivolumab compared with nivolumab in participants with high risk MIUC. In this study participants will be enrolled in a safety run-in phase to receive autogene cevumeran + nivolumab. This phase will be conducted to monitor and ensure the safety of study participants. After all participants in the safety run-in have been enrolled to receive autogene cevumeran + nivolumab, further participants will be randomization in either autogene cevumeran + nivolumab or the saline + nivolumab arm.

The purpose of this study is: * To investigate the optimal timing for revaccination after the initial RSVPreF3 OA vaccine dose, * To evaluate the long-term immune persistence and safety up to 5 consecutive RSV seasons (approximately 60 months) of a single dose of RSVPreF3 OA vaccine, * To give the opportunity to participants who received only placebo in the RSVOA=ADJ- 006 study, to receive a dose of the RSVPreF3 OA vaccine and collect additional safety information.

This study will look at how much CagriSema lowers blood sugar and body weight in people with type 2 diabetes. CagriSema is a new investigational medicine. Doctors cannot yet prescribe CagriSema. CagriSema will be compared to a medicine called tirzepatide. Doctors can prescribe tirzepatide in some countries. Participants will either receive CagriSema or tirzepatide. Which treatment the participant will receive is decided by chance. For each participant, the study will last for up to 1 year and 4 months.

This is a Phase 1 study to assess the safety of ERX-315 in patients with advanced solid tumors that have failed approved systemic therapies.

The purpose of this study is to characterize the safety and tolerability of ALTA2618 in adults with AKT1 E17K-mutant advanced solid tumors.

The study is designed to evaluate the preliminary efficacy, safety, population PK profile, and immunogenicity of CPX101 in subjects with obesity or overweight with weight related comorbidities but without diabetes mellitus.

This is a double-blind, randomized, multiregion, comparative phase ? clinical study designed to evaluate the efficacy and safety of HLX22 in combination with trastuzumab and chemotherapy as first-line treatment in patients with HER2-positive locally advanced/metastatic adenocarcinoma of the gastric and/or gastroesophageal junction (G/GEJ).Eligible subjects will be randomized to the two groups based on a 1:1 ratio. Enrolled subjects shall be treated with the study drug until the loss of clinical benefit, death, intolerable toxicity, withdrawal of informed consent, or other reasons specified by the protocol (whichever occurs first).