Albion

Researchers are evaluating a Chlamydia messenger RNA (mRNA) vaccine candidate in adults aged 18 to 29 years. This Phase 1/2 study aims to assess the safety, immune response, and effectiveness of three dose levels (low, medium, and high) of the vaccine. The study includes three initial Sentinel Cohorts to carefully monitor safety before progressing to a Main Cohort, ensuring participant well-being throughout the process. The study involves intramuscular injections of either the Chlamydia mRNA vaccine or a placebo solution. Participants in the Sentinel Cohorts receive different dose levels in a stepwise manner to identify safe dosing. After the initial safety assessment, the Main Cohort participants receive study interventions accordingly. Each participant undergoes follow-up for up to 12 months after their last dose, with the total participation lasting about 18 months. During the study, researchers closely monitor for immediate and delayed adverse events, including injection site and systemic reactions, up to 7 days after each injection. They also track unsolicited and medically attended adverse events up to 6 months and serious or special interest events up to 12 months after the final dose. Additional safety monitoring includes biological test results in a specific safety subset. This extensive follow-up helps ensure a thorough evaluation of the vaccine's safety and immune response over time.

Researchers are evaluating the safety, pharmacokinetics, and pharmacodynamics of TRB-061, a drug given by subcutaneous injection, in healthy adults and patients with moderate-to-severe atopic dermatitis (AD). This Phase 1a/1b randomized, double-blind, placebo-controlled study includes multiple parts to assess single and multiple doses. The study may adjust the number of dosing groups in the first two parts based on ongoing results. In Part 1, healthy adults receive a single dose of TRB-061 or placebo, followed by 12 weeks of monitoring. In Part 2, healthy adults receive three doses every four weeks over eight weeks, with a 10-week follow-up. Part 3 involves participants with moderate-to-severe AD receiving four doses of TRB-061 or placebo over 12 weeks, followed by a follow-up period. After the main study, those on placebo may have the option to receive the active treatment. Participants will undergo regular safety assessments including medical history, physical exams, laboratory tests, and monitoring for adverse events from screening through follow-up. Researchers will measure the incidence of adverse events and serious adverse events across all parts of the study. The total participation duration varies by part but includes follow-up lasting up to 12 weeks after dosing to ensure safety and collect pharmacological data.