Albion

Researchers are evaluating the safety, immune response, and effectiveness of different doses of a Chlamydia messenger RNA mRNA vaccine in adults aged 18 to 29 years. The study includes three initial Sentinel Cohorts to carefully assess safety at low, medium, and high dose levels before expanding to a Main Cohort. The overall goal is to understand how well this vaccine candidate works and its safety profile in young adults. Participants will receive three injections of either a low, medium, or high dose of the Chlamydia mRNA vaccine or a placebo. The injections are given intramuscularly. The study is randomized and placebo-controlled, with multiple groups based on whether participants have prior exposure to Chlamydia trachomatis. The study is designed with stepwise safety assessments in the Sentinel Cohorts followed by evaluation in a larger Main Cohort. During the study, participants will be monitored for immediate reactions up to 30 minutes after vaccination and for side effects up to 12 months following the last injection. Immune responses will be measured through blood tests before and after each vaccine dose. Participants will be followed for about 18 months from the start, including safety monitoring, laboratory tests, and evaluation of immune responses to the vaccine and placebo injections.

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 1a1b randomized, double-blind, placebo-controlled study includes healthy participants and those with AD to better understand how TRB-061 behaves in the body and its effects. The study is divided into three parts to assess single and multiple doses in different groups. In Part 1, healthy participants receive a single ascending dose of TRB-061 or placebo and are followed for 12 weeks. Part 2 involves healthy participants receiving three doses of TRB-061 or placebo every four weeks over eight weeks, followed by a 10-week follow-up. Part 3 includes patients with moderate-to-severe AD randomized to receive either one of two doses of TRB-061 or placebo every four weeks for 12 weeks. Participants in Part 3 may opt into a crossover period where treatment assignments are switched for another 12 weeks, followed by a final follow-up until the end of the study. Participants will undergo safety assessments including monitoring of adverse events, pharmacokinetic blood tests, and clinical evaluations throughout the study and follow-up periods. Healthy participants are screened for general health and ECG abnormalities before enrollment, while AD patients must have a confirmed diagnosis and moderate-to-severe disease. Regular visits are scheduled for dosing and evaluations, and researchers will measure safety outcomes primarily by tracking adverse events from screening through follow-up. The study aims to complete by February 2028.