Rishon Lezion

This clinical trial is a phase 2a, multinational, multicenter, double-blind, randomized, placebo-controlled study aimed at evaluating the safety, tolerability, and pharmacokinetics PK of OMN6 in patients with hospital-acquired bacterial pneumonia HABP or ventilator-associated bacterial pneumonia VABP caused by the Acinetobacter baumannii complex ABC. The purpose is to identify safe and well-tolerated doses of OMN6 and understand its behavior in the body when added to standard therapies. Participants receive either OMN6 or a placebo alongside background antibiotic treatment with meropenem and colistin. OMN6 is given in three dosing cohorts 50 mg, 100 mg, or 150 mg, each administered as three 3-hour intravenous infusions on a single day, while meropenem plus colistin treatment continues for 7 to 14 days. The comparator group receives matching placebo infusions under the same schedule plus the background antibiotics. Throughout the study, participants are closely monitored for safety and the pharmacokinetics of OMN6, including measures such as maximum concentration, time to maximum concentration, area under the curve, and half-life. Safety assessments focus on the 28 days following the single-day infusion. The trial includes randomized assignment and double-blinding to ensure unbiased evaluation. The total study duration extends until primary completion in March 2027.

Researchers are evaluating the safety and effectiveness of once-weekly Somatrogon compared to daily Growth Hormone Genotropin for treating children born Small for Gestational Age SGA or with Idiopathic Short Stature ISS. This randomized, open-label study involves pre-pubertal children who have not previously received growth hormone treatment. The study is planned to last 12 months, including a screening period of up to 30 days, and aims to measure growth outcomes in these children. The study includes two groups one with 140 children with SGA and another with 114 children with ISS. Both groups will be randomly assigned to receive either Somatrogon once weekly via a subcutaneous disposable prefilled pen or Genotropin daily subcutaneous injections using commercial growth hormone delivery devices. Treatment will continue for 12 months for all participants. Participants will be involved in regular visits to assess growth through measurements such as annual height velocity, height standard deviation scores, bone maturation, and levels of Insulin-like Growth Factor-1 IGF-1. Quality of life related to health will also be evaluated before and after treatment. Monitoring includes laboratory tests and maintaining stable hormone levels. The total participation duration includes the screening and 12 months of treatment, with assessments at multiple time points throughout the study.