ANZCTR search results

This is a Phase 1, open-label, single-ascending-dose study evaluating the safety, tolerability, and pharmacokinetics (PK) of Viaca - a fixed-dose oral combination of sildenafil (a PDE5 inhibitor) and cabergoline (a dopamine D2 agonist) - versus sildenafil monotherapy and cabergoline monotherapy in healthy adult male volunteers. Approximately 30 participants are enrolled across 5 sequential cohorts (6 each). Each participant receives a single oral dose. The combination targets erectile dysfunction through both vascular and neuroendocrine pathways, aiming for efficacy at lower component doses.

An investigator-initiated 10-participant Feasibility Study to assess a novel glaucoma drainage implant, VW-50.

Multiple myeloma (MM) is a plasma cell malignancy characterized by the proliferation of clonal plasma cells in the bone marrow. The disease primarily localizes to the bones and bone marrow, with resultant cytopenias, bone pain, fractures, infections, hypercalcemia, and renal failure. This study aims to evaluate the safety and change in disease activity of etentamig in combination with pomalidomide compared with standard available therapies in participants with relapsed or refractory multiple myeloma who have received 1-3 prior lines of treatment, including lenalidomide. Etentamig is an investigational drug being developed for the treatment of relapsed or refractory multiple myeloma. This is a randomized, open-label study. The study will include a safety run-in portion and a randomized portion. The safety run-in participants will receive etentamig in combination with pomalidomide. The randomized portion of the study participants will receive either etentamig with pomalidomide or Standard Available Therapies (SATs). Approximately 520 participants will be enrolled in the study at approximately 200 sites worldwide. Prior to initiation of the randomized portion of the study, the safety run-in will be conducted in which participants will receive etentamig injections plus oral pomalidomide. Following review of the safety run-in data and per protocol-defined criteria, the study will advance to the randomized portion where participants will be randomized to receive either etentamig injections plus oral pomalidomide or investigator's choice of SAT: SC daratumumab, oral pomalidomide, and oral/ IV dexamethasone (DPd); SC daratumumab, IV carfilzomib, and oral/IV dexamethasone (DKd); or SC teclistamab monotherapy. The total study duration is approximately 75 months There may be higher treatment burden for participants in this trial compared to their standard of care due to study procedures. Participants will attend regular visits during the study at a hospital or clinic. The effects of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Non-alcoholic fatty liver disease is a chronic, serious, life-threatening, inflammatory liver disease characterized by increased liver fat content, inflammation, and progressive fibrosis. The overall prevalence of non-alcoholic fatty liver disease is rapidly rising world-wide. ECC4703 is a potential new treatment for non-alcoholic fatty liver disease. The purpose of this research is to investigate the safety, tolerability and pharmacokinetics of sulfasalazine and pitavastatin when combined with ECC4703.

The relationship between exercise and atrial fibrillation (AF) seems to follow a J-shaped curve: while moderate activity reduces AF risk, both insufficient and excessive endurance exercise increase susceptibility. In athletes, standard treatments such as antiarrhythmic drugs often provide only partial symptom control and may impair performance through fatigue, chronotropic incompetence and side effects. Pulmonary vein isolation (PVI) may offer a more definitive therapeutic option but carries risks of atrial fibrosis, stiffening, and altered autonomic regulation, which may also influence exercise capacity. The investigators hypothesize that ablation will have a significant impact-either beneficial or detrimental-on the physical performance of athletes with AF. However, existing evidence is limited to small studies with inconsistent findings, underscoring the need for a dedicated study. This prospective, multicentre interventional study will assess the effects of cardiac ablation in 100 endurance athletes with AF. Participants will undergo comprehensive pre- and post-ablation phenotyping, including electrocardiogram (ECG), cardiopulmonary exercise testing (CPET), echocardiography, Holter monitoring, and detailed training data collection (efficiency factor, acute and chronic training load). Clinical follow-up will extend to 12 months post-ablation. The primary endpoint is the change in peak VO2 (mL/kg/min) measured before ablation and after the procedure. Secondary analyses will explore: * Autonomic adaptations: including changes in maximum heart rate, heart rate recovery, heart rate reserve, and heart rate variability. * Cardiac function: alterations in diastolic and atrial function assessed by echocardiography. * Training and performance: objective measures such as efficiency factor, decoupling, functional threshold power, critical power, and acute and chronic training load. * Technique comparison: differences in outcomes between pulsed field and radiofrequency ablation (e.g. atrial function, troponin release, …). * Sex-specific effects: recognising the underrepresentation of women in sports cardiology research, the investigators will include female athletes according to incidence and evaluate potential differences in treatment response between sexes. * Predictors of AF recurrence in endurance athletes

A Phase 1, double-blind, randomized study to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of single dose and multiple doses of CG-0416 in healthy participants. HongKong Curegene Innovation Co. Limited is developing the study drug CG-0416 as a potential new treatment for overweight and obesity. The purpose of this research is to investigate the safety, tolerability (if any side effects occur), pharmacokinetics (the amount of study drug or any of its breakdown products in your body) and pharmacodynamics (how the study drug affects your body), of single and multiple oral doses of a study drug called CG-0416.

This is an open-label, multi-center, phase 1/2 dose-escalation and dose expansion study evaluating the safety, tolerability, pharmacokinetics (PK), and anti-tumor activity of ML-016 in participants with advanced solid tumors with lung and/or liver involvement (primary or metastatic disease).

This clinical trial consists of two parts: phase 2 and phase 3. The goal of phase 2 of this clinical trial is to compare which dose level of AMT-116 works better to treat advanced or metastatic non-squamous EGFR-Wildtype non-small cell lung cancer (NSCLC) in adults. It will also learn about the safety of AMT-116. The main questions it aims to answer are: * Which level of AMT-116 works better to treat advanced or metastatic non-squamous EGFR-Wildtype NSCLC? * What medical problems do participants have when taking AMT-116? The goal of phase 3 of this clinical trial is to compare AMT-116 to study doctor's choice (a kind of retainable treatment for you in the opinion of the study doctor) to see if AMT-116 works better to treat advanced or metastatic non-squamous EGFR-Wildtype NSCLC. In both parts of this trial, participants will receive AMT-116 or study doctor's choice every 2 weeks until the study doctor thinks you are benefiting from your participation or until your disease progresses or you are unable to tolerate the study drug

The purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of TLN-499 in combination with venetoclax in participants with relapsed/refractory solid tumors.

This Phase 1 Study will evaluate the safety, tolerability, pharmacokinectics and pharmacodynamics of XmAb412 in healthy adult participants