Butterfield, Australia

A Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BCX17725

Parts 1 and 2 are randomized, placebo-controlled, single-ascending-dose (SAD) and multiple-ascending-dose (MAD) study parts, respectively, in healthy participants. Part 3 will evaluate multiple dose administrations in participants with Netherton syndrome in an open-label design.

A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis

Eating Disorders Genetics Initiative 2

Individualised Dose Optimisation of Ganciclovir in Immunocompromised Children Trial (ID-MAGIC)

Immunocompromised children between 1 months to 18 years with cytomegalovirus viraemia who are admitted to one of the participating sites will be enrolled into the trial if eligible (see eligibility criteria) and randomly allocated into two groups. Children in the 'control- standard dosing group' will receive standard intravenous ganciclovir treatment for cytomegalovirus viraemia at a standard dosing of at 5mg/kg IV BD. Children in the "intervention: individualised dosing using a web app group" will receive a personalised intravenous ganciclovir dose calculated using an individualised IV ganciclovir dosing app. This approach considers the patient's weight, creatinine level, and target drug exposure, allowing for tailored dosing based on individual pharmacokinetic parameters. The virological clearance by 6 weeks of the children in each of the two groups will be compared.

A Study to Compare the Efficacy and Safety of BMS-986393 Versus Standard Regimens in Adult Participants With Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma (QUINTESSENTIAL-2)

Nutrition in Paediatric Critical Care

Study With [225Ac]Ac-FL-020 in mCRPC Participants

The aim of this Phase 1, First-in-Human, Open-label Trial is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of [225Ac]Ac-FL-020 as a single agent in participants with metastatic Castration-Resistant Prostate Cancer (mCRPC). [111In]In-FL-020 serves as a surrogate for 225Ac-FL-020 for dosimetry purposes. The trial is divided into two parts: dose escalation in Part 1 and cohort expansion in Part 2.

Phase II Study of the Combination of Durvalumab (MEDI4736) (PDL1 Inhibitor) and Olaparib (PARP Inhibitor) in Advanced Cholangiocarcinoma After Initial Chemotherapy and Durvalumab (BIL-PPP)

The primary objectives are (i) To describe the efficacy of PARPi and PDL1 inhibition in the maintenance setting of metastatic cholangiocarcinomas. (ii) To refine selection of the patient population who are most likely to benefit from the combination of PDL1 (Durvalumab) and PARP (Olaparib) inhibition in the maintenance setting following initial chemotherapy (cisplatin + gemcitabine + Durvalumab) (post hoc translational analysis). The secondary objectives are (i) To evaluate toxicity of the combination of durvalumab and olaparib. (ii) To evaluate progression-free and overall survival with the combination of durvalumab and olaparib (PFS, OS).

Effectiveness of a Grape Seed Extract on Circulatory Measures in Healthy Adults

Effect of Maolactin™ FMR on Exercise Recovery, Inflammation, and Muscle Comfort in an Otherwise Healthy Population