Fortitude Valley

Researchers are evaluating the safety and tolerability of single and multiple intravenous doses of GIGA-2339 in adults with chronic Hepatitis B Virus HBV infection. This Phase 1 randomized, double-blind, placebo-controlled study aims to understand how the drug behaves in the body and monitor any treatment-related side effects in participants who have been living with HBV for at least six months. Participants will receive either a single intravenous infusion of GIGA-2339 or a placebo in increasing doses on the first day. Following this, participants will receive multiple intravenous infusions of the drug or placebo once every four weeks at the dose determined during the single-dose phase. The study includes two parts Part 1 for single ascending doses and Part 2 for multiple ascending doses, both designed to assess safety, tolerability, and how the drug is processed in the body over time. During the study, participants will undergo regular evaluations including blood tests to measure drug concentration and monitor liver function, safety assessments for any adverse events, and other laboratory tests over periods up to 105 days for single doses and up to 245 days for multiple doses. Researchers will track treatment-emergent adverse events, serious adverse events, and detailed pharmacokinetic data to understand the drugs behavior. Participation may last several months, with visits scheduled according to dosing and monitoring needs.

Researchers are evaluating the effects of Levagen supplementation on symptoms of diabetic peripheral neuropathy DPN in adults aged 18 to 75 years with this condition. This Phase 2 clinical trial aims to determine how Levagen impacts neuropathic pain and other related health measures over a 12-week period. The study compares Levagen to a placebo to assess its potential benefits for people with DPN. Participants will be randomly assigned to take either Levagen capsules or placebo capsules twice daily with water after food. Each Levagen capsule contains 150 mg of palmitoylethanolamide PEA, totaling 300 mg daily. The placebo capsules contain microcrystalline cellulose. The treatment period lasts 12 weeks, during which participants attend remote visits every 3 weeks and visit a local pathology center for blood draws. During the study, participants will be monitored for changes in neuropathic pain severity, symptom inventories, safety through adverse event reporting and lab markers, vital signs, sleep quality, mood, glycemic control, body measurements, and rescue medication use. Assessments occur from baseline through week 12. The trial includes detailed safety and efficacy measurements to understand the effects of Levagen on diabetic peripheral neuropathy symptoms.

This research aims to evaluate a new delivery method of spinal cord stimulation using the Evoke System for patients with chronic pain in the trunk andor limbs. The study focuses on a novel approach called ECAP-controlled closed-loop spinal cord stimulation, which includes new software and hardware features to better manage pain. The trial is designed as a prospective, multicenter, single-arm feasibility study sponsored by Saluda Medical Pty Ltd. Participants will receive treatment with the Evoke Spinal Cord Stimulation SCS System, which continuously measures and records evoked compound action potentials ECAPs and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude. This closed-loop system aims to provide a more personalized and controlled pain management experience. The study includes only one experimental treatment group using this device. During the study, participants will be closely monitored for changes in ECAPs as measured by the Evoke SCS System through the completion of the study, which can last up to two years. Assessments will focus on the devices performance in controlling pain signals, with ongoing evaluations to track the stability and effectiveness of the stimulation. Participants will provide informed consent and comply with study requirements throughout their involvement.