ANZCTR search results

The primary objective of the study is to determine the effects of KAI-9531 subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.

The purpose of this study is to evaluate the efficacy and safety of standard-of-care chemotherapy and bevacizumab with or without INCA33890 in the first-line treatment of metastatic microsatellite stable colorectal cancer.

The purpose of this study is to determine the safety and tolerability of XmAb657 in healthy participants and participants with IIM. Participants will be given XmAb657 subcutaneously (SC) by injection under the skin.

The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

The main purpose of this study is to assess the efficacy of RO7268489 in adults with progressive multiple sclerosis (PMS) receiving ocrelizumab. After the end of the double-blind period, an open-label (OL) extension may allow eligible participants to receive open-label RO7268489.

This study is a dose finding study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of subcutaneous CBP-4888 in hospitalized participants with Preterm Preeclampsia receiving Standard of Care, Expectant Management. Eligible participants are between 26 +0/7 and 35 +6/7 weeks gestational age and clinically appropriate for inpatient expectant management. Eligible participants will receive standard of care expectant management for their pregnancy with the only study interventions being one subcutaneous dose of CBP-4888. Participants will: * receive a single subcutaneous injection dose of CBP-4888 and will be followed through delivery and for 42 days (+14 days) after delivery. Participants will be followed through 6 weeks post delivery. * Infants will be evaluated immediately postpartum and then followed through 24 months of age with standard infant and pediatric assessments with phone calls made to parents.

The goal of this clinical trial is to learn the safety, tolerability and pharmacokinetics of single and multiple doses of HY8931 in healthy adult participants. The main questions it aims to answer are: * How is the safety and tolerability following administration of single and multiple doses of HY8931 in healthy adult participants? * What is the PK character of HY8931 following administration of single and multiple doses of HY8931 in healthy adult participants? Researchers will compare HY8931 to a placebo (a look-alike substance that contains no drug) to see if HY8931 is safe and well tolerated. Participants will take HY8931 or a placebo once or twice in single dose group or multiple dose group. And will be follow-up until Day 90.

The purpose of this research study is to evaluate the safety of and the body's immune response to single and multiple vaccinations in healthy men and women. We want to find out what effects GBP511 has on you and your health. We are doing this study to find out: If the study drug has any side effects when given as single and multiple vaccinations. If reactogenicity, an indication that the immune systems is working and is preparing to protect the body against future infection, occurs. This is a normal physical inflammatory response that occurs after vaccination, manifesting as localised reactions that may include pain or redness at the injection site, or systemic symptoms such as headache or fever. If immunogenicity which is when GBP511 causes your body to make antibodies against the non-harmful viral proteins contained within GBP511, called 'neutralising antibodies (Nab),' occurs. And if GBP511 will cause the specialised cells of the body's immune system to mount a defence against the non-harmful viral proteins contained within GBP511, called 'cell-mediated immunity (CMI)'. In this study, GBP511 will be administered with and without adjuvant, CAS-1. An adjuvant is an ingredient used in some vaccines that help produce a stronger immune response in the people receiving the vaccine and thus helps the vaccine work better. This study will recruit approximately 368 participants in total and will be conducted in two stages: Stage 1 will look at two vaccinations with GBP511 when given with and without the CAS-1 adjuvant; and Stage 2 will look at either one or two vaccinations with two candidate GBP511 vaccines chosen from Stage 1 of the study. Participants will be required to attend Linear's clinical unit on two separate occasions to receive their two vaccinations. On the first day of dosing (Visit 2/Day 1) and second day of dosing (Visit 5/Day 29), we will be testing a single dose of the study drug in up to 168 healthy volunteers who will be divided into 3 groups. Group 1, Groups 2 and 3 will have 56 people each. These 3 groups will be divided into treatment subgroups, with a total of 6 test subgroups and 3 control subgroups. In all groups, neither you or the study doctor will know what subgroup you are part of, and therefore what treatment (GBP511 or Comirnaty+ placebo) you will receive.

The goal of the REVEAL PTSD study is to test how well the Senseye DT works as a diagnostic test for Post-traumatic Stress Disorder (PTSD) in adults 18 and older who are experiencing one or more symptoms that might be related to PTSD. The Senseye DT is software as a medical device (SaMD) and is an iPhone app that administers a series of simple tasks on the phone while recording video during the tasks through the front-facing camera. The videos are analyzed by a an Artificial Intelligence (AI) algorithm to identify physiologic signals that might be indicative of PTSD. Data collected in this study will be used to train and tune the AI algorithm, then test it for accuracy. The main questions this study aims to answer are: 1. How accurate is the Senseye DT in detecting PTSD compared to structured clinical interviews, the current clinical standard for diagnostic testing? 2. How accurately does the Senseye DT predict PTSD severity? 3. How fast is the Senseye DT to use compared to structured clinical interviews? Participants will attend a virtual screening visit via video call to determine eligibility and consent to participate. Once enrolled, participants will attend 2 or 3 additional study visits: * Visit 1: A virtual visit where standard mental health assessments will be given by clinical raters trained in mental health and administering these structured clinical interviews. These assessments include the Structured Interview Guide for the Montgomery-Asburg Depression Rating Scale (SIGMA), the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A), and the MINI International Neurodiagnostic Interview. The Clinician-Administered PTSD Scale for DSM-5 Revised Version (CAPS-5-R) may also be conducted, if randomly selected. * Visit 2: A visit to use the Senseye DT. For participants near one of the study's physical site locations, this visit will be done in person at the site. For all others, this visit will be conducted virtually. * Visit 3: For participants not randomly selected to have the CAPS-5-R administered at Visit 1, a third and final visit will be scheduled for this assessment. This visit will be conducted virtually. The total expected participation time for enrolled participants is 6-7 hours over the course of 2-3 weeks.

The goal of this clinical trial is to test a new medicine called GSK5764227, which delivers a toxin directly to cancer cells to destroy them while sparing healthy cells. The study will combine GSK5764227 with standard treatments to evaluate its safety, examine how the body processes it, check if it triggers any immune responses, and assess whether it can shrink or control cancer.