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Набира участници Фаза 1

A Pharmacokinetic Study of YN001 in Healthy Participants

Healthy Volunteers

This is a Phase 1, single-center, open-label study designed to evaluate the pharmacokinetics (PK), safety, and immunogenicity following a single dose administration in healthy adult volunteers.

Начало: 18.11.2025 Край: 18.02.2026 Възраст: 18–65 г. Лечение

Australia Beijing Inno Medicine Co., Ltd. NCT07190885

Набира участници Фаза 1/2

Study of ARO-MAPT-SC in Healthy Subjects and Subjects With Early Alzheimer's Disease

Alzheimer Disease Alzheimer Disease, Early Onset

Study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics of ARO-MAPT-SC compared to placebo in adult healthy volunteers and in participants with early Alzheimer's disease (AD), defined as mild cognitive impairment due to AD and mild AD dementia.

Начало: 18.11.2025 Край: 01.06.2027 Възраст: 18–80 г. Лечение

New Zealand Arrowhead Pharmaceuticals NCT07221344

Набира участници Фаза 1

Study of an RSV-hMPV-PIV3 Trivalent Vaccine Candidate VXB-251 in Older Adults

Lower Respiratory Tract Disease Healthy Participants

This study is being done to find out how safe and effective a new combined vaccine candidate, called VXB-251, is for older adults. The vaccine candidate is designed to protect against three common viruses that can cause respiratory tract infections: * RSV (respiratory syncytial virus) * hMPV (human metapneumovirus) * PIV3 (parainfluenza virus type 3) Two components of this vaccine (RSV and hMPV) have already been tested in people before, as part of another study for a two-in-one vaccine. However, this is the first time that the PIV3 component and all three components together (RSV, hMPV, and PIV3) are being tested in people. The vaccine candidate will be given as a single intramuscular injection. The study will also test unlicensed comparator vaccines and a placebo (a substance that looks like the real vaccine but doesn't contain any active ingredients) that target none, one or two of these viruses to see whether combining all three components affects safety or how well the immune system responds.

Начало: 17.11.2025 Край: 24.04.2027 Възраст: 60–83 г. Превенция

Australia Vicebio Australia Proprietary Limited NCT07295028

Набира участници Фаза 1

A Study of KIVU-107 in Participants With Locally Advanced or Metastatic Solid Tumors

Advance Solid Tumors

This is a 2-part, first-in-human, open-label study to determine the safety and tolerability of KIVU-107, a PTK7-directed antibody-drug conjugate, in participants with locally advanced or metastatic solid tumors.

Начало: 13.11.2025 Край: 31.03.2030 Възраст: от 18 г. Лечение

Australia, United States Kivu Bioscience Inc. NCT07229313

Набира участници Фаза 2

A Study to Find Out Whether BI 765423 Has an Effect on Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF) With or Without Standard Treatment

Idiopathic Pulmonary Fibrosis

This study is open to adults who are at least 40 years old and have idiopathic pulmonary fibrosis (IPF). People can participate in the study if they have a forced vital capacity (FVC) greater than or equal to 45% of the predicted value and fibrosis of 20% or more confirmed by a high-resolution computed tomography (HRCT) scan. The purpose of this study is to find out if a medicine called BI 765423 can improve lung function in people with IPF. The study will compare BI 765423 with a placebo to see if there is a difference in lung capacity after 3 months of treatment and will also look at changes in certain markers related to lung health. Participants are put into two groups randomly, which means by chance. One group receives the study medicine, and the other group receives a placebo. Placebo looks like BI 765423 but does not contain any study medicine. The study medicine is given as an infusion into a vein every four weeks. Participants are in the study for 8-10 months. During the study, participants may continue their regular treatment for IPF. During the study they visit the study site several times for screening, treatment, and follow-up. Doctors regularly test lung function by measuring FVC and take blood samples to measure study endpoints. The results are compared between the two groups to see whether the treatment works. The doctors also check participants' health and take note of any unwanted effects.

Начало: 13.11.2025 Край: 02.09.2027 Възраст: от 40 г. Лечение

Australia, Belgium, Canada +7 Boehringer Ingelheim NCT07036523

Набира участници Фаза 2

A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer

Ovarian Cancer

Ovarian cancer is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC). Participants must have confirmation of folate receptor alpha (FRa) positivity by the Ventana folate receptor 1 (FOLR1) Assay. Mirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 2 substudies and further into groups called treatment arms. In substudy 1, arms A-C, participants will receive 1 of 2 doses of MIRV with Bev, or Bev alone. In substudy 2, arms D and E, participants will receive 1 of 2 doses of MIRV with carboplatin, followed by MIRV alone. Approximately 320 participants will be enrolled in the study at 100 sites around the world. Participants will receive intravenously (IV) infused MIRV with IV infused carboplatin, or IV infused Bev, or IV infused Bev alone. The total study duration will be approximately 40 months. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.

Начало: 13.11.2025 Край: 01.01.2029 Възраст: от 18 г. Лечение

Australia, South Korea AbbVie NCT07059845

Набира участници

Choroidal Melanoma Patient-Reported Outcome Study (CM-PRO) in a Subset of AU-011-301 (CoMpass) Subjects

Choroidal Melanoma Indeterminate Lesions Uveal Melanoma Ocular Melanoma

To assess subject-centric real-world evidence of QoL outcomes in subjects enrolled in the global Phase 3 AU-011-301 clinical trial.

Начало: 12.11.2025 Край: 15.08.2028

Australia Aura Biosciences NCT07421739

Набира участници Фаза 3

A Clinical Trial of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

Alzheimers Disease

The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \[MCI\] to mild dementia due to AD).

Начало: 12.11.2025 Край: 07.06.2028 Възраст: 50–90 г. Лечение

Argentina, Australia, Brazil +12 Hoffmann-La Roche NCT07170150

Набира участници Фаза 2

A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression

Ovarian Cancer

This study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.

Начало: 12.11.2025 Край: 24.10.2027 Възраст: 18–99 г. Лечение

Australia, Belgium, Japan +5 Incyte Corporation NCT07023627

Набира участници Фаза 1/2

Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Acute Lymphoblastic Leukemia

B-cell Acute Lymphoblastic Leukemia (B-ALL)

The study is intended to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of AZD4512 in patients with relapsed/refractory B-Cell acute lymphoblastic leukemia (r/r B-ALL).

Начало: 12.11.2025 Край: 03.07.2028 Възраст: от 12 г. Лечение

Australia, Canada, China +6 AstraZeneca NCT07109219

Набира участници

Early Phase Study Using the 'Pivot Extend' System as a Treatment for Patients With Tricuspid Regurgitation

Tricuspid Regurgitation

Participants with severe tricuspid regurgitation may require heart surgery to repair or replace the tricuspid valve. However, there is a high risk associated with these surgeries and it is often not feasible for elderly patients or those with other medical conditions. The goal of this clinical investigation is * To assess the safety of the investigational device "Pivot Extend" in participants aged 18 years or over with severe and clinically symptomatic Tricuspid Regurgitation (TR) deemed suitable for percutaneous valve intervention * To evaluate device success, procedural success and clinical outcomes in improving TR symptoms following implantation of the "Pivot Extend" device

Начало: 11.11.2025 Край: 01.03.2027 Възраст: от 18 г. Лечение

Australia Tau Medical Australia Pty Ltd NCT07172477

Набира участници Фаза 1/2

Early Phase Study of KESONOTIDE™in Participants With Solid Tumours

Prostate Cancers Breast Cancer Lung Cancers Ovarian Cancer +3

This clinical trial is an adaptive study of a novel vimentin inhibitor in cancers. It is an open label, multicentre, single ascending dose level in phase I and cohort exploration in phase II. Primary objective is to evaluate safety and tolerability of KESONOTIDE™ as a monotherapy in participants with advanced/metastatic solid cancers. Secondary objective is to characterise the pharmacokinetics of KESONOTIDE™. Phase I study will enrol 20-32 participants and Phase II approximately 80 participants.

Начало: 07.11.2025 Край: 26.10.2027 Възраст: от 18 г. Лечение

Australia Filamon LTD NCT06926075

Набира участници Фаза 2

Brivekimig for the Treatment of Moderate to Severe Hidradenitis Suppurativa

Hidradenitis Suppurativa

This is a Phase 2b, global, multicenter, sequential, randomized, double-blind, placebo-controlled, parallel group, dose-ranging study in participants with moderate to severe hidradenitis suppurativa. The purpose of the main study is to assess the efficacy and safety of brivekimig in a dose-ranging study of participants with moderate to severe HS. Study details include: The study duration (per participant) will be up to approximately 60 weeks for participants not transitioning into the long-term extension (LTE) study and will be up to approximately 52 weeks for participants transitioning into the LTE study. The randomized treatment duration will be up to approximately 48 weeks.

Начало: 06.11.2025 Край: 27.04.2028 Възраст: от 18 г. Лечение

Australia, Canada, Chile +15 Sanofi NCT07170917

Набира участници Фаза 2

A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization

Bronchiectasis With Pseudomonas Aeruginosa Colonization

AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.

Начало: 06.11.2025 Край: 14.06.2028 Възраст: от 12 г. Превенция

Argentina, Australia, Belgium +21 AstraZeneca NCT07088926

Набира участници Фаза 1/2

Study of PRA-216 in Healthy Participants and Participants With Mild-to-Moderate Asthma

Mild to Moderate Asthma

Phase 1 of this study will consist of 2 parts * Part 1 will evaluate the safety, tolerability, pharmacokinetics and immunogenicity of PRA-216 in healthy volunteers through single ascending dose administered by either intravenous (IV) or subcutaneous (SC). * Part 2 will evaluate the safety, tolerability, pharmacokinetics (PK) and immunogenicity of PRA-216 in healthy volunteers with repeat doses of multiple ascending dose administered subcutaneously. Phase 2a of this study is a randomized, double-blind, placebo-controlled study to investigate the efficacy, safety and immunogenicity of PRA-216 in participants with mild to moderate asthma. The dose of PRA-216 for this phase was determined from Phase 1.

Начало: 04.11.2025 Край: 31.01.2027 Възраст: 18–65 г. Лечение

Australia, New Zealand Prana Therapies Inc NCT07245368

Набира участници Фаза 1/2

Phase 1/2a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Effect on Body Weight of RN3161 as Monotherapy and in Combination With Tirzepatide in Adults With Overweight and Obesity

Obesity &Amp; Overweight

Study to assess the safety, 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 RN3161 alone (healthy volunteers) and RN3161 with tirzepatide (overweight and obese subjects)

Начало: 04.11.2025 Край: 15.08.2027 Възраст: 18–65 г. Лечение

Australia Ikaria Bioscience Pty Ltd NCT07245771

Набира участници Фаза 2

Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of SION-719 When Added to Trikafta

Cystic Fibrosis (CF)

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SION-719 when given to people with CF who are already taking Trikafta.

Начало: 03.11.2025 Край: 01.07.2026 Възраст: 18–65 г. Лечение

Australia, United States Sionna Therapeutics Inc. NCT07108153

Набира участници

Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease

Ventricular Tachycardia Cardiomyopathies Arrhythmias, Cardiac Ventricular Arrythmia

The goal of this randomized clinical trial is to test the efficacy of stereotactic body radiation therapy (SBRT) in treating ventricular tachycardia (VT) in patients with advanced structural heart disease. The main questions it aims to answer are: * What is the efficacy of SBRT compared to catheter ablation (CA) in achieving a ≥ 75% reduction in VT burden at 6 months * What is the comparable safety profile of SBRT vs CA Researchers will compare SBRT and CA (standard of care).

Начало: 03.11.2025 Край: 20.12.2027 Възраст: от 18 г. Лечение

Australia Western Sydney Local Health District NCT06360939

Набира участници Фаза 1

A Study of AZD2962, an IRAK4 Inhibitor (IRAK4 [a Body Protein] Blocker), in Participants With Haematologic Neoplasms (Blood Cancers)

Haematologic Neoplasms

The purpose of the study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics, and preliminary efficacy of AZD2962, an Interleukin-1 Receptor-Associated Kinase 4 (IRAK4) inhibitor, as monotherapy and in combination with other agents in participants with haematologic neoplasms.

Начало: 03.11.2025 Край: 20.10.2028 Възраст: 18–110 г. Лечение

Australia, Japan, South Korea +4 AstraZeneca NCT07064122

Набира участници

Using a Speech-Generating Device to Support Communication in Childhood Dementia

Childhood Dementia Genetic Disease Nonverbal Communication Augmentative and Alternative Communication

Individuals with childhood dementia experience loss of developmental skills and many have limited verbal speech. The aim of this clinical trial is to examine how well a speech-generating device supports the communication skills of participants with childhood dementia. The speech-generating device is a communication program loaded onto an iPad. This is a crossover trial, meaning that each participant will receive both the treatment (device) and a control (usual care; no device) phase. The order in which each participant receives the device versus the usual care (no device) will depend on which group the participant is assigned to. The changes in communication in each phase will then be compared. During the trial, participants can expect to complete a series of assessments and attend a total of 2 x 1-hour therapy session per week for 6 weeks.

Начало: 03.11.2025 Край: 01.05.2027 Възраст: 3–12 г. Поддържаща грижа

Australia Murdoch Childrens Research Institute NCT07039084

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