South Yarra

Researchers are evaluating the effectiveness of switching to injectable GS-3242 plus Lenacapavir LEN compared to continuing the oral medication Biktarvy bictegraviremtricitabinetenofovir alafenamide, BFTAF in adults with well-controlled HIV-1 infection. The study has two parts Part A focuses on people in treatment Groups 1, 2, and 3 at Week 35, while Part B focuses on Groups 4 and 3 at Week 26. This phase 2 trial aims to assess the efficacy of these treatments in virologically suppressed people with HIV-1. Participants are randomized to receive either oral loading doses of GS-3242 combined with LEN tablets followed by intramuscular IM injections of GS-3242 and LEN for up to 52 weeks, at different doses depending on the group, or to continue daily oral BFTAF for up to 52 weeks. Part B participants are enrolled non-randomized to receive oral loading doses and IM injections of GS-3242 and LEN at specific doses. The study compares these treatment approaches to evaluate viral control over specified time points. During the study, participants will have their HIV-1 RNA levels monitored at Week 26, Week 35, and Week 52 using the FDA Snapshot Algorithm to measure viral suppression. Additional assessments include CD4 cell counts, drug concentration levels in blood, and monitoring for treatment-emergent adverse events. The studys total duration extends up to 52 weeks for treatment and includes safety and efficacy evaluations at multiple time points.

Researchers are evaluating the effects of CBL-514 injection on reducing abdominal subcutaneous fat in adults with Grade 3 or Grade 4 abdominal fat. This phase 2b randomized, placebo-controlled study aims to assess the efficacy, safety, and tolerability of this treatment compared to a placebo. Approximately 250 participants with specific abdominal fat levels will be included to better understand this approach for fat reduction. Participants are randomly assigned to receive either CBL-514 injection or a placebo consisting of 0.9% Sodium Chloride. Each participant will undergo up to 4 subcutaneous treatments to the abdomen, spaced 3 weeks apart, with doses up to 120 mL per treatment. The study includes a long-term re-treatment phase to monitor effects over time. During the study, participants will be assessed for changes in abdominal fat using clinician and patient-reported scales at baseline and follow-up points up to 12 weeks after the final treatment. Safety and tolerability will also be monitored throughout. The primary outcome focuses on the percentage change in abdominal fat from baseline to 4 weeks after the last treatment. Participants will be involved in study visits for treatment administration and evaluations, with overall participation lasting several months.

Researchers are evaluating the safety and effectiveness of FB102 in adults with severe to very severe alopecia areata, a condition causing significant hair loss. This randomized, double-blind, placebo-controlled Phase 1 study aims to better understand how FB102 works compared to a placebo in this patient group. Up to 32 participants will be randomly assigned in a 3 to 1 ratio to receive either FB102 or a matching placebo. Both treatments are given intravenously. The study will monitor participants over several weeks, assessing safety and changes in hair loss severity. Participants will be involved in the study for up to 36 weeks after their first dose. During this time, they will undergo regular evaluations including tracking treatment-related side effects and measuring changes in hair loss using the Severity of Alopecia Tool SALT score. Researchers will carefully monitor safety and treatment responses throughout the study.

Researchers are evaluating ziltivekimab, a new medicine not yet approved anywhere, to see if it can help people who were hospitalized due to a heart attack. The study aims to find out if ziltivekimab can reduce the development of heart disease and prevent future heart attacks or strokes. This is a Phase 3 clinical trial comparing ziltivekimab to a placebo in patients with acute myocardial infarction. Participants will receive an initial loading dose of ziltivekimab or matching placebo by injection under the skin as soon as possible after an invasive heart procedure, within 36 hours for STEMI or 48 hours for NSTEMI patients. After the loading dose, they will get monthly injections of the same study medicine for up to two years, in addition to their standard care. During the study, participants will be monitored for major cardiovascular events such as heart attack, stroke, and cardiovascular death. Researchers will also track other heart-related outcomes and safety measures over a period of up to 25 months. The study involves regular visits for injections, assessments, and laboratory tests to evaluate the medicines effects and patient health throughout the trial.

Researchers are evaluating a drug called cemiplimab for treating early-stage Cutaneous Squamous Cell Carcinoma CSCC, a type of skin cancer. Cemiplimab helps the immune system attack cancer cells by targeting a protein called PD-1 on immune cells. The studys main goal is to compare how well cemiplimab works when injected directly into the lesion versus standard surgery. Participants will be randomly assigned to receive either cemiplimab injected into the lesion or undergo primary surgery using techniques like Mohs surgery or other complete margin assessment methods. The study will assess side effects and how well cemiplimab performs compared to surgery in treating the cancer. During the study, participants will be monitored for event-free survival up to 3 years. Researchers will also evaluate lesion response, treatment-related adverse events, and sizes of surgical or biopsy defects. The total participation period extends up to 3 years, with regular assessments to track safety and treatment effectiveness.