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Предстои набиране Фаза 1

Dose-Finding Study of NBX-100 in Healthy Adult Participants

Healthy Participants

NB-2025 P1 001 is a Phase Ib study that will investigate the pharmacokinetics, pharmacodynamics, safety, tolerability, psychological effects of escalating doses of NBX-100 in healthy volunteers. A 28-day screening period is followed by a preparation visit with psychologist in Week 1. From Week 2 to Week 5, participants will receive a once weekly dose of study treatment, receiving four doses in total. Participants will attend a follow-up visit each day immediately after each dosing day. In Week 6, participants will attend an integration visit with a psychologist, and in Week 10, participants will attend an end-of-study follow-up visit. Participants will have safety, psychological, PK, PD, and pharmacogenomic assessments.

Начало: 31.01.2026 Край: 30.05.2026 Възраст: 21–50 г. Лечение

Australia Neurala Biosciences NCT07399899

Предстои набиране Фаза 1

A Phase 1, Multicenter Imaging Study of LNTH-2403 in Participants With Locally Advanced or Metastatic Solid Tumors.

Imaging Colorectal Cancer Head and Neck Squamous Cell Carcinoma Non-Small Cell Lung Cancer +1

LNTH-2403 (177Lu-DOTA-DUNP19) is a lutetium-177 radiolabeled, fully humanized monoclonal antibody (mAb) that binds with high specificity and affinity to leucine-rich repeat containing 15 (LRRC15), a transforming growth factor (TGF) - β-driven biomarker expressed on the cell membrane of cancer cells and/or cancer-associated fibroblasts 9CAFs) in select tumor types. Upon binding, LNTH-2403 is rapidly internalized, such that it can serve as a dual-purpose agent for both non-invasive imaging and radiotheranostic treatment of LRRC15- positive tumors. This first-in-human (FIH) imaging study will evaluate the safety and imaging of LNTH-2403 in participants with locally advanced or metastatic solid tumors.

Начало: 30.01.2026 Край: 31.10.2027 Възраст: от 18 г. Диагностика

Australia Radiopharm Theranostics, Ltd NCT07272642

Предстои набиране Фаза 2

Tirzepatide Combined With Cognitive-Behavioural Therapy (CBT) for Adults With Alcohol Use Disorder (AUD) and Overweight/Obesity (OOB)

Alcohol Use Disorder (AUD) Overweight or Obese Comorbidities and Coexisting Conditions

The investigators approach is to conduct a Phase II Double-Blind randomised controlled trial with individuals with co-occurring Alcohol Use Disorder and overweight/obesity (AUD-OOB) to receive either a sub-cutaneous injection of Tirzepatide (2.5 mg for 4 weeks followed by 5 mg for 4 weeks) or visually matched sham saline injection, in combination with a structured behavioural intervention (Take Control CBT Module). The primary aim of the study is evaluate the efficacy of the intervention on the number of heavy drinking days (defined as 5+ standard drinks for men, 4+ standard drinks for women) during the final month of treatment (weeks 5 to 8) compared to baseline. The secondary aim of the study is to assess treatment effects on alcohol related (e.g. number drinks consumed per day, abstinent days) and cardio-metabolic outcomes (e.g. body weight in kg, waist circumference, blood pressure, HbA1c, total cholesterol etc...), and summarise safety outcomes associated with use (e.g. frequency and severity of side effects, number of serious adverse events, treatment related discontinuations). The study will also include neurobiological assessments such as functional magnetic resonance imaging (fMRI) and lab-based psychophysiology to assess the impact of tirzepatide on change in brain activity and autonomic responses to alcohol and food cues.

Начало: 15.01.2026 Край: 15.01.2028 Възраст: 21–75 г. Лечение

Australia South West Sydney Local Health District NCT07292519

Предстои набиране

BELUGA: Better to Exchange ETT for LMA Before Extubation in Children Under General Anaesthesia

Endotracheal Extubation Airway Anesthesia Paediatric

During surgery, anaesthetists can use an endotracheal tube (ETT) to facilitate ventilation. At emergence from general anaesthesia, there are two techniques for removal of the ETT: (1) the ETT is removed when the child is waking up in (awake removal); or (2) the ETT is removed while still under anaesthesia(deep removal). Currently there is no evidence to suggest either technique is safer - deep removal of the ETT may decrease the risk of overall airway complications, including cough and desaturations. However, it may be associated with increased airway obstruction compared with awake extubation in paediatric patients. In our institution, a further technique has become increasingly common practice: removing ETT deep to avoid coughing and desaturation, then inserting a laryngeal mask airway (LMA) which can be removed once the patient is awake in the postoperative care unit (PACU), avoiding the risk of airway obstruction coupled with deep airway removal. The aim of the study is to assess whether deep removal of an ETT and exchange to an LMA, is superior to awake ETT removal with regards to the occurrence of postoperative respiratory adverse events. In this study, patients will be randomised to awake removal of ETT or deep removal of an ETT and exchange to an LMA. Data will be collected regarding the rate of respiratory adverse events in either group, as well as the incidence of post-operative pain, delirium and nausea and vomiting.

Начало: 12.01.2026 Край: 30.01.2029 Възраст: до 16 г. Превенция

Australia, Brazil, Italy +2 Telethon Kids Institute NCT07204990

Предстои набиране Фаза 1/2

A Trial to Learn How Safe AZD9750 is and How Well it Works in People With Metastatic Prostate Cancer When Given With or Without Other Anticancer Drugs

Prostate Cancer

ANDROMEDA is a first-in-human, Phase I/II, open-label, multicenter study of AZD9750 in participants with metastatic prostate cancer. The trial evaluates safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of AZD9750 as monotherapy and in combination with saruparib.

Начало: 05.01.2026 Край: 04.01.2029 Възраст: от 18 г. Лечение

Australia, Canada, Japan +1 AstraZeneca NCT07336446

Предстои набиране Фаза 2

Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus (T2DM)

Phase 2 Randomized Study of PG-102 vs Placebo and Semaglutide in Type 2 Diabetes Mellitus

Начало: 01.01.2026 Край: 01.12.2026 Възраст: 18–75 г. Лечение

Australia ProGen. Co., Ltd. NCT07187856

Предстои набиране Фаза 2

A 2-Part Study to Assess Efficacy, Safety and Tolerability of BMB-101 for the Treatment of Patients With Prader-Willi Syndrome.

Prader-Willi Syndrome

The goal of this clinical trial is to evaluate the safety and effects of a new drug called BMB-101 in people with Prader-Willi Syndrome (PWS). This study is designed as a multi-centre, double-blind, randomized, placebo controlled 2-part study with a blinded main phase followed up an open label extension phase.

Начало: 01.01.2026 Край: 01.03.2027 Възраст: 18–65 г. Лечение

Australia Bright Minds Biosciences Pty Ltd NCT07266324

Предстои набиране

Evaluation of the Phantom X Implantable EMG Sensor System for Myoelectric Prosthesis Control

Upper Limb Amputation Below Elbow (Injury) Wrist Disarticulation Transradial Amputation

The CYBORG Study is a first-in-human clinical investigation evaluating the safety and performance of the Phantom X System, an implantable electromyography (EMG) sensor array designed to provide control of upper-limb prostheses. The study will assess surgical feasibility, device function, signal quality, and the system's ability to support intuitive prosthetic control during functional tasks. Participants will undergo implantation of the Phantom X sensors and complete a series of in-clinic visits to assess functional performance of the Phantom X system. Patient-reported outcomes will also be collected at various timepoints.

Начало: 01.01.2026 Край: 01.06.2027 Възраст: от 18 г. Устройства

Australia Phantom Neuro Inc. NCT07325708

Предстои набиране Фаза 1/2

Ketamine-Enhanced Therapy for Individuals With Alcohol Use Disorder and Depression: A Pilot Study (KET-DUAL)

Alcohol Use Disorder (AUD) Major Depressive Disorder (MDD) Comorbidities and Coexisting Conditions

To assess the safety, feasibility and preliminary efficacy of ketamine-enhanced therapy (KET) for alcohol use disorder (AUD) and comorbid major depressive disorder (MDD) in an open-label, single arm, pilot clinical trial.

Начало: 10.12.2025 Край: 10.12.2027 Възраст: 18–70 г. Лечение

Australia South West Sydney Local Health District NCT07247370

Предстои набиране Фаза 1/2

A Study of DB-1324 in Advanced/Metastatic Gastrointestinal Tumors

Gastrointestinal Cancer

This study, the first clinical trial, aims to determine the safety, tolerability, pharmacokinetics, pharmacodynamics, maximum tolerated dose, and antitumor activity of DB-1324.

Начало: 01.12.2025 Край: 01.12.2028 Възраст: от 18 г. Лечение

Australia, United States DualityBio Inc. NCT07263594

Предстои набиране Фаза 2

Acute Metabolic Effects of Tirzepatide in Type 1 Diabetes

Type 1 Diabetes Mellitus

This study will examine the effects of Tirzepatide (TZP), a glucagon-like peptide 1 (GLP1) - gastric inhibitory peptide (GIP) co-agonist, on metabolism in type 1 diabetes (T1D). Research participants with T1D will undergo measures of insulin sensitivity, and hormone levels post-meal, post-hypoglycemia and during the overnight period. These measures will be performed prior to, and after 6 weeks of treatment with TZP or placebo.

Начало: 01.12.2025 Край: 31.12.2027 Възраст: 18–65 г. Лечение

Australia Garvan Institute of Medical Research NCT06820281

Предстои набиране Фаза 1

Exploratory Study of Inhaled Afatinib Dimaleate PK Profile

Lung Cancer Oral Cancer Melanoma

This is a pilot Phase I open-label randomized single-dose two-period crossover study (in the EDDIS project) evaluating the bioequivalence, pharmacokinetics (PK), safety, and tolerability of inhaled afatinib dimaleate compared with the reference oral afatinib dimaleate in healthy volunteer smokers. The study will enroll healthy adult volunteers smoker to assess the systemic exposure and lung deposition of inhaled afatinib dimaleate. Participants will receive both the test inhaled formulation and the reference oral formulation in separate periods with delayed phase between treatments. Key endpoints include maximum plasma concentration (Cmax), area under the concentration-time curve (AUC), and lung deposition assessed via bronchoalveolar lavage (BAL), frequency of occurrence of side effects and cases of toxicity during the studies

Начало: 09.11.2025 Край: 07.05.2026 Възраст: 21–55 г. Лечение

New Zealand Petrov, Andrey NCT06897735

Предстои набиране

Exercise to Improve Neurovascular Function in Breast Cancer Survivors

Breast Cancer Survivorship

Study Rationale: Breast cancer survivors are more likely to develop cardiovascular disease (CVD) or neurocognitive disease than age-matched counterparts without a history of cancer diagnosis. Some anti-cancer treatments cause damage to the cells of heart and the walls of blood vessels, which may exacerbate neurovascular dysfunction and cancer-related cognitive impairment (symptoms such as 'chemo-brain'), as well as accelerating the onset of neurocognitive disease. Therefore, effective policies and therapeutic strategies are needed to minimize neurovascular dysfunction and neurocognitive disease in at-risk populations like breast cancer survivors. Regular exercise training is effective in slowing or preventing the development of CVD. Furthermore, higher fitness levels are associated with lower dementia risk in older adults, which may be due to better neurovascular function. However, whether exercise training incorporated into a Cardio-Oncology Rehabilitation and Exercise (CORE) programme can improve neurovascular function in breast cancer survivors is currently unknown. Therefore, the primary aim of this study will be to determine the effect of a CORE programme on neurovascular function in long-term breast cancer survivors. Study Description: This study will be a randomised controlled trial to investigate the effect of a CORE programme on neurovascular function in long-term breast cancer survivors. Participants will complete a series of baseline assessments, including lifestyle questionnaires, a cognitive function assessment, dual-energy x-ray absorptiometry (DXA), a cardiopulmonary exercise test (CPET), ultrasound assessments of arterial stiffness and vascular function, and brain magnetic resonance imaging (MRI). Furthermore, participants will wear a blood pressure monitor at home for 24 hours, and a physical activity monitor for seven days. Following completion of baseline assessments, participants will be randomised to either the CORE program or a 'usual care' group. The CORE program will include a 6-month exercise training program supervised by an Exercise Physiologist at the Baker Heart and Diabetes Institute. The usual care group will carry on with healthcare from their usual healthcare provider(s) for 6 months. Participants will then complete two follow-up study visits following completion of the 6-month intervention period, with identical procedures to the baseline study visits. Study Duration: This study involves two baseline study visits in month 1, followed by two study visits in month 7. Participants randomised to the CORE program will be asked to attend the Baker Heart and Diabetes Institute on a weekly basis for supervised exercise training sessions. However, the supervised exercise training sessions will be provided by a mix of in-person, video-conferencing and tele-health modes depending on each participants availability and needs.

Начало: 03.11.2025 Край: 29.08.2026 Възраст: 45–75 г. Превенция

Australia Baker Heart and Diabetes Institute NCT06925529

Предстои набиране

Assessment of Whether Telehealth Family Psychoeducation for Major Depressive Disorder is Doable

Major Depressive Disorder (MDD)

The goal of this single-arm interventional study is to assess the feasibility and acceptability of co-designed telehealth family psychoeducation (FPE) among individuals with major depressive disorder (MDD) and families. The study will also assess the intervention's preliminary impact on personal recovery, antidepressant medication adherence, depression severity, and medication necessity beliefs and concerns. The main questions it aims to answer are: * What are patients', families', and mental health professionals' views about telehealth FPE for MDD? * What are the feasibility and acceptability of telehealth FPE for MDD among individuals with MDD and their families? * What is the preliminary impact of telehealth FPE for MDD on personal recovery, antidepressant medication adherence, depression severity, and medication necessity beliefs and concerns? Study participants will include individuals with MDD who have prescriptions for antidepressant medications and their family members. Participants will receive three biweekly FPE sessions and a six-week follow-up session via telehealth using a single-family format. The study intervention, telehealth family psychoeducation for MDD, will cover structured modules to enhance participants' understanding of MDD and its treatment, coping strategies, and self-efficacy skills. It will also focus on recognising early signs of relapse and empowering participants to engage in treatment decision-making actively. Hence, the study intervention is termed the Supportive Program for Advancing Recovery, Knowledge, and Empowerment in Depression (SPARKED). At baseline, post-intervention, and follow-up, participants with MDD will complete self-reported measures for personal recovery, antidepressant medication adherence, depression severity, and medication necessity beliefs and concerns. In contrast, their family members or caregivers will complete only an outcome measure for medication necessity beliefs and concerns.

Начало: 01.11.2025 Край: 01.06.2026 Възраст: от 18 г. Поддържаща грижа

Australia University of Southern Queensland NCT07014241

Предстои набиране Фаза 2

Single-dose Prophylactic INdomethacin in Extremely Preterm Infants

Extreme Prematurity Intraventricular Hemorrhage Morbidity;Newborn

In Canada, about 900 babies each year are born very early (\

Начало: 01.11.2025 Край: 31.03.2031 Възраст: до 12 г. Превенция

Australia, Canada, United States University of British Columbia NCT06572917

Предстои набиране

An Extension Study to Assess the Long-term Safety of the Genio® System

Obstructive Sleep Apnea of Adult

The objective of this study is to assess the long-term safety of the Genio® system in adult OSA patients with and without complete concentric collapse of the soft palate who have successfully been implanted with the Genio IS in a Nyxoah sponsored Clinical Investigation. (Serious) Adverse Device Effects and Device Deficiencies in subjects previously implanted with a Nyxoah Genio implantable stimulator (IS) and having the IS still in-situ (with therapy activated or deactivated) will be collected. The main question it aims to answer is: what is the long term safety profile of the Genio System? Participants will be asked to refer back to the site per standard of care and report on any (Serious) Adverse Device Effects and Device Deficiencies that may have occurred.

Начало: 01.11.2025 Край: 17.07.2029

Australia Nyxoah S.A. NCT05939141

Предстои набиране Фаза 3

Improving Survivorship for Critically Ill Patients Aged 65 and Over

Critical Illness Recovery Outcomes Care Coordination

IMPROVE-65 is a randomised control trial designed specifically for people aged over 65 who have survived critical illness. It aims to support patients and general practitioners by providing timely, personalised information to help them work together to make informed goals and decisions about their care after hospital discharge. The aim of the study is to improve recovery and avoid preventable hospital readmissions.

Начало: 01.11.2025 Край: 01.02.2028 Възраст: от 65 г. Здравни услуги

Australia Australian and New Zealand Intensive Care Research Cent NCT07175961

Предстои набиране Фаза 1

Phase Ib Trial of 177Lu-PSMA-I&T Therapy in Combination With Olaparib and Pembrolizumab in Patients With Metastatic Castration Resistant Prostate Cancer

Metastatic Castrate Resistant Prostate Cancer (mCRPC)

This phase 1b trial is designed to evaluate the safety and tolerability of olaparib in combination with 177Lutetium-Prostate Specific Membrane Antigen (177 Lu-PSMA) and pembrolizumab in patients with metastatic castration resistant prostate cancer (mCRPC).

Начало: 01.11.2025 Край: 01.12.2028 Възраст: от 18 г. Лечение

Australia Peter MacCallum Cancer Centre, Australia NCT07090369

Предстои набиране Фаза 3

Confirmatory Study of Govorestat in CMT-SORD

Charcot-Marie-Tooth Disease With Sorbitol Dehydrogenase Deficiency (CMT-SORD)

This study is designed to assess the long-term efficacy and clinical benefit of AT-007 in patients with CMT-SORD. This randomized, double-blind study will assess the effect of govorestat compared to placebo in patients with CMT-SORD for up to 36 months.

Начало: 01.10.2025 Край: 01.01.2029 Възраст: 16–65 г. Лечение

Australia, France, Germany +4 Applied Therapeutics, Inc. NCT07191912

Предстои набиране

The Family Foundations Trial

Mental Health Outcomes

In this project, researchers are exploring different ways to support the wellbeing and relationships of families with young children (0-12 years). People in regional and rural communities often live with the threat of bushfires, floods, drought, severe storms, and other extreme weather events. Some families have been affected by these disasters and are still trying to recover. Researchers will test two different ways of supporting families in regional and rural Victoria: Family Foundations (FF): An 8-session program to promote parent wellbeing, parenting partnerships, and communication. All parents/caregivers/parenting partners in the family participate in sessions delivered by a health professional online. Family Life Check-In: A brief 30-minute telephone call with a health professional to discuss family wellbeing and relationships, and identify any supports needed. The goal of this trial is to learn whether FF works to reduce mental health difficulties for regional and rural families. The main question it aims to answer is: Compared to Family Life Check-In, does Family Foundations lead to fewer mental health difficulties? Participants will: Complete an online survey before randomisation, after they have received FF or Family Life Check-In, and six months after starting the project. Take part in either Family Foundations or Family Life Check-In.

Начало: 01.10.2025 Край: 01.08.2027 Възраст: от 18 г. Лечение

Australia Deakin University NCT07126379

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