Fortitude Valley

Researchers are evaluating how well two microalgal omega-3 supplements are absorbed compared to a fish oil source and a placebo in healthy adults aged 18 to 64. This randomized, double-blind, placebo-controlled Phase 3 study aims to compare the bioavailability of EPA and DHA, important omega-3 fatty acids, from these sources over a 6-week period. Participants are assigned to take one of four products daily for 6 weeks: three capsules of life'sTM omega O1035DS nTG, life'sTM omega O3020DS nTG, MEG-3 3323rTG, or a placebo containing corn and soybean oils. Each omega-3 supplement capsule contains 300 mg of EPA and DHA combined, totaling 900 mg daily. The placebo capsules contain equal parts corn and soybean oils taken three times daily. During the study, participants attend four clinic visits where blood samples and other assessments are conducted. The main outcome measured is the change in blood levels of EPA and DHA from the start to week 6. Researchers monitor health status and ensure participants maintain their usual diet and exercise routines. The overall participation lasts for the 6-week supplementation period with scheduled evaluations to track absorption and safety.

Researchers are evaluating the safety and tolerability of GIGA-2339, given as single and multiple intravenous doses, in adults with chronic Hepatitis B Virus (HBV) infection. This Phase 1, randomized, double-blind, placebo-controlled study focuses on participants who are HBeAg negative and have stable or no nucleos(t)ide analogue treatment. The study aims to monitor adverse events and pharmacokinetics of GIGA-2339. Participants will receive either GIGA-2339 or placebo by intravenous infusion. The study includes single ascending dose (SAD) and multiple ascending dose (MAD) periods, with safety monitored up to Day 105 for SAD and up to Day 245 for MAD. The dosing schedule and details are arranged to assess how the body processes the drug and how well it is tolerated. During the study, participants will undergo evaluations including laboratory tests, ECGs, liver imaging, and monitoring for treatment-emergent adverse events. Researchers will track drug levels and safety signals throughout the study. Participants are expected to remain on stable antiviral therapy if applicable and use contraception as required. The overall participation timeframe covers the dosing and follow-up periods to ensure thorough safety assessment.

Researchers are evaluating the effectiveness of Levagen+ supplementation in treating symptoms of diabetic peripheral neuropathy (DPN) in adults aged 18 to 75 years with DPN. This is a Phase 2 randomized, placebo-controlled trial designed to assess changes in neuropathic pain severity over a 12-week period. The study aims to measure improvement in overall neuropathic pain symptoms compared to placebo. Participants will be randomly assigned to take either Levagen+ or a placebo capsule twice daily with water after food. Each Levagen+ capsule contains 175 mg of the supplement with 150 mg of palmitoylethanolamide (PEA), totaling 350 mg daily. Placebo capsules contain microcrystalline cellulose. Treatment lasts 12 weeks, with remote visits every 3 weeks and visits to a local pathology center for blood draws. During the study, participants will have regular remote check-ins and attend a local center for blood collection. Researchers will monitor neuropathic pain severity changes from baseline to week 12. Participants will be asked to maintain their current diet and exercise habits and avoid joining other clinical trials during the study. Safety and adherence will be closely followed throughout the 12-week period.

Researchers are evaluating a new method of delivering Evoke Compound Action Potentials (ECAP)-controlled closed-loop spinal cord stimulation (SCS) using updated software and/or hardware features for people living with chronic pain in the trunk and/or limbs. This feasibility study aims to test and assess the novel treatment delivery with the Evoke SCS System to better understand its potential use for managing chronic pain. Participants will receive the Evoke Spinal Cord Stimulation System, which is a device that provides ECAP-controlled, closed-loop spinal cord stimulation. The study is single-arm and multicenter, focusing on patients who have already undergone or are planning to undergo implantation of the Evoke System within its approved use. The study does not include a comparison group. During the study, researchers will monitor changes in Evoke Compound Action Potentials (ECAPs) using the Evoke SCS System. Participants will be followed for up to two years to assess this primary outcome. Throughout participation, individuals will be asked to comply with study requirements and provide informed consent, with ongoing evaluation to understand the treatment's impact on chronic pain.