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NCT ID: NCT06028347 Active, not recruiting - Influenza, Human Clinical Trials

Safety, Reactogenicity, and Immunogenicity Study of a Self-Amplifying mRNA Influenza Vaccine in Healthy Adults

Start date: October 5, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase 1, first-in-human, randomized, placebo-controlled, observer blind study. The effect of two doses of an investigational vaccine on safety, reactogenicity, kinetics and magnitude of the post-vaccination antibody response will be evaluated at different timepoints as compared to placebo in healthy adults. Approximately 96 evaluable subjects will be enrolled in this study; n=72 receiving investigational vaccine and n=24 receiving placebo. The study has a screening period (Day -28 to Day -1), a treatment period (Day 1 to Day 43) and a follow-up period (Day 44 to Day 202).

NCT ID: NCT06019065 Active, not recruiting - Healthy Volunteers Clinical Trials

A SAD, MAD and Food Effect Study to Evaluate the Safety, Tolerability, PK, and PD of AJA001 in Healthy Subjects

Start date: September 13, 2023
Phase: Phase 1
Study type: Interventional

This is a Phase 1, double-blind, randomized, placebo- controlled, SAD and MAD study to assess safety, tolerability, PK, and PD of AJA001 in fasted healthy participants. Food effect will be evaluated in one cross-over SAD fed dose cohort.

NCT ID: NCT05984992 Active, not recruiting - Clinical trials for Idiopathic Pulmonary Fibrosis

The First-in-human Study of SRN-001 in Healthy Participants

Start date: September 8, 2023
Phase: Phase 1
Study type: Interventional

SRN-001 is a novel small interfering RNA (siRNA) drug being developed to treat fibrosis using Self Assembled Micelle inhibitory ribonucleic acid (SAMiRNA™) technology. Amphiregulin (AREG) is a growth factor involved in fibroblast proliferation and myofibroblast transformation which is the hallmark of fibrosis in lung and kidney tissues. AREG is a downstream gene overexpressed by Transforming growth factor-β (TGF-β) during fibrosis, promoting fibroblast to myofibroblast transition (FMT). SRN-001 is designed to downregulate generating amphiregulin by RNA interference (RNAi). The goal of this clinical trial is to evaluate safety, tolerability, and pharmacokinetics in healthy participants. This trial is first-in-human clinical trial to develop SAMiRNA™ to utilize as therapeutic use.

NCT ID: NCT05972785 Active, not recruiting - Breast Cancer Clinical Trials

Long-term Use of CCB and Breast Cancer Risk

Start date: July 1, 2022
Phase:
Study type: Observational

The goal of this retrospective observational study is to examine whether long-term calcium channel blocker (CCB) use is associated with the development of breast cancer amongst women enrolled in three longitudinal cohort studies in Australia and the Netherlands . The main questions it aims to answer are: - Is long-term CCB use associated with the development of breast cancer amongst women enrolled in three longitudinal cohort studies in Australia and the Netherlands and what is the dose-response nature of this association. - Does differences in the association between calcium channel blocker use and the development of breast cancer exist between Australian and Dutch women. The investigators will utilise data from the Australian Longitudinal Study on Women's Health (ALSWH) , 45 and Up Study and Rotterdam study.

NCT ID: NCT05970289 Active, not recruiting - Clinical trials for Chronic Hepatitis B Virus Infection

Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients

Start date: August 22, 2023
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.

NCT ID: NCT05960097 Active, not recruiting - SARS-CoV-2 Clinical Trials

A Study on the Safety and Immune Response of Investigational COVID-19 mRNA Vaccines in Healthy Adults

Start date: August 1, 2023
Phase: Phase 2
Study type: Interventional

The purpose of Part A of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccines to control vaccine. The purpose of Part B of this study is to assess the immune response and safety of a booster dose of investigational COVID-19 mRNA vaccines in healthy adults. The study will compare the investigational vaccine under three different storage conditions.

NCT ID: NCT05956223 Active, not recruiting - Essential Tremor Clinical Trials

The Development of a System for Measurement of Tremor

Start date: November 30, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to develop a system which can be used to measure movements in people with Essential Tremor (with or without dystonia). The main questions it aims to answer are: - Can individuals with Essential Tremor be distinguished from individuals without tremor using Virtual Reality (VR) - Can the current Essential Tremor Assessment Scale (the TETRAS) be reproduced in VR - Can Essential Tremor be quantified using a measurement system - Can Dystonia be quantified using a measurement system. Participants will don the equipment used to measure their tremor and replicate a series of standardized movements to measure their tremor, in and out of the VR platform. The assessment will take no longer than an hour.

NCT ID: NCT05952869 Active, not recruiting - Clinical trials for Hypercholesterolemia

A Study of MK-0616 (Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH

Start date: August 8, 2023
Phase: Phase 3
Study type: Interventional

The goal of this study is to evaluate the efficacy, safety, and tolerability of MK-0616 in adult participants with heterozygous familial hypercholesterolemia. The primary hypothesis is that MK-0616 is superior to placebo on mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24.

NCT ID: NCT05938023 Active, not recruiting - Clinical trials for Duchenne Muscular Dystrophy

A Study of ATL1102 or Placebo in Participants With Non-ambulatory Duchenne Muscular Dystrophy

Start date: May 18, 2023
Phase: Phase 2
Study type: Interventional

This Phase IIb study is a two part, multicenter study to evaluate the efficacy, safety, pharmacokinetics and pharmacodynamics of ATL1102 in non-ambulant boys with Duchenne Muscular Dystrophy aged 10 to <18 years old. The study includes a randomised, double-blind, placebo-controlled treatment period (Part A), followed by an open labelled treatment period (Part B).

NCT ID: NCT05923476 Active, not recruiting - Depressive Disorder Clinical Trials

Electroconvulsive Therapy and Concomitant Lithium in Depressive Disorder: A Pilot Study

ECT+LITHIUM
Start date: June 1, 2023
Phase: Early Phase 1
Study type: Interventional

Depression is a major psychiatric illness associated with significant morbidity and mortality. Electroconvulsive therapy (ECT) is the most effective treatment for depression and arguably the safest. However, a sizable proportion of patients (20%-30%) do not get well with ECT. Typically, ECT is given as a course extending over weeks and then discontinued. Approximately 50% of patients become unwell again in one year after the completion of ECT even when they use antidepressant medications. Moreover, ECT brings recovery after a series of treatment sessions, usually with a range of 6-20. Each ECT session poses logistic issues. Lithium has robust antidepressant effect when used with antidepressant medications. A combination of lithium and ECT has been studied previously in mania and found to be safe at a lithium level in the human body below 0.6 mEq/L. There is a gap in the literature about the use of lithium and ECT combination in depression. This pilot study aims to investigate the feasibility and safety of conducting a randomized controlled trial comparing lithium and ECT against placebo and ECT. Participants will have either placebo and ECT or lithium ECT at an equal probability. They will be approached for an expression of interest, invited to take part in a consenting session, screened for the eligibility for the study, and assessed for the severity of depression, and cognitive function and then for the improvement in depression. Lithium blood level will be monitored five days after commencement of lithium and each dose change. Participants will be assessed for adverse reactions after each ECT using a formal adverse monitoring report form. Recruitment numbers, trial retention and completion rates and adverse events will be reported.