Taringa

Researchers are evaluating the use of PTP-001 MOTYS, an allogeneic human placental tissue particulate, for treating knee osteoarthritis OA. This Phase 3, multicenter, randomized, double-blind, placebo-controlled trial aims to assess the safety, tolerability, and effectiveness of a single injection of PTP-001 compared to placebo over a 52-week period in adults aged 40 to 80 with symptomatic and radiographically confirmed knee OA. Participants will be randomly assigned to receive one injection into the target knee of either 200 mg PTP-001 or 4 mL of placebo saline solution. The study includes a screening period lasting up to 28 days before treatment, a one-day treatment phase when the injection occurs, and a follow-up phase of 12 months to monitor outcomes and safety. Approximately 260 participants will be enrolled, with 130 in each treatment group. During the study, participants will undergo assessments at multiple time points, including evaluations of knee pain and function using standardized scales such as WOMAC and patient global assessments. The main outcomes focus on the proportion of participants showing strict improvement in knee pain and function at 6 months, with additional measurements at 9 and 12 months. Safety and tolerability will also be monitored throughout the follow-up period.

Researchers are comparing two forms of long-acting drugs, cabotegravir ultra long-acting CAB ULA plus rilpivirine ultra long-acting RPV ULA versus cabotegravir long-acting CAB LA plus rilpivirine long-acting RPV LA, in adults and adolescents who have HIV and are already virologically suppressed on antiretroviral therapy ART. The study aims to evaluate the effectiveness, safety, and tolerability of these treatments in maintaining viral suppression. Participants are randomly assigned to receive either the CAB ULA plus RPV ULA combination or the CAB LA plus RPV LA combination. Both interventions involve administering these drugs as long-acting injectable treatments. The study is conducted as a phase III trial with parallel groups, where participants continue their assigned treatment regimen throughout the study period. During the trial, participants are monitored regularly to assess their HIV viral load, specifically tracking the percentage of participants with plasma HIV-RNA levels at or above 50 copiesmL at month 11. Additional measures include evaluating virologic failure, drug-related adverse events, and resistance to the study drugs up to month 23. Researchers also track immune cell counts and drug concentrations over time. The total duration of participation extends through to the study completion date, with ongoing safety and efficacy assessments.

Researchers are evaluating the safety and immune response of different vaccine formulations targeting the Respiratory Syncytial Virus RSV monovalent antigen and the Influenza AH5N1 hemagglutinin subtype 5 H5 antigen in healthy adults aged 18 to 49 years. This phase 1 study aims to understand how well these vaccines work and how safe they are for this age group, with participation durations varying by treatment group and study stage. Participants receive vaccines through intramuscular injections. For certain groups, injections are given on day 1 and day 22 with the H5 Flu vaccines, while others receive a single injection on day 1 with the RSV vaccines. The study is divided into two stages, with Stage 1 lasting approximately 6 to 7 months depending on the arm, and Stage 2 lasting about 7 months for all arms. Vaccines are given according to a randomization schedule across multiple experimental arms. Throughout the study, participants will be monitored closely for side effects such as injection site reactions, systemic symptoms, and any adverse events up to 6 months after vaccination. Researchers will collect blood samples to measure antibody responses before and after vaccination at various time points. The study includes detailed safety assessments, including biological tests and documentation of any serious adverse events or events leading to discontinuation. Participants immune responses to both RSV and Flu H5 antigens will be measured using specific antibody tests over the course of the study.