Mont Royal

Researchers are evaluating the safety and tolerability of a new drug called ABCL575 in healthy adult volunteers. This phase I study is designed as a randomized, double-blind, placebo-controlled trial with single ascending doses to understand how participants react to increasing amounts of ABCL575 compared to a placebo. The study involves five groups of participants, each group receiving a higher dose than the previous one. Participants will receive a single subcutaneous injection of either ABCL575 or a placebo (normal saline 0.9%). The study has five planned cohorts, labeled A1 to A5, each including eight healthy volunteers. The dose of ABCL575 will escalate with each cohort to carefully observe effects at different levels. During the study, participants will be monitored from day 0 through day 337 for any adverse events, changes in vital signs, physical exams, laboratory tests including blood and urine analysis, ECG heart safety checks, and responses at the injection site. The research team will carefully track and assess any side effects or reactions to ensure participant safety throughout the study period, which lasts approximately 11 months after the initial dose.

Researchers are evaluating the safety, tolerability, effectiveness, pharmacokinetics, and pharmacodynamics of ALN-2232 in adults with obesity. This study looks at single ascending doses, multiple doses of ALN-2232 alone, and multiple doses of ALN-2232 combined with tirzepatide. The trial focuses on participants with a body mass index (BMI) between 30 and less than 40 kg/m² and a hemoglobin A1c below 6.5%. The study is a Phase 1/2 trial designed to better understand these treatments in this population. Participants will receive ALN-2232 or placebo through subcutaneous injections. Some will also receive tirzepatide injections alongside ALN-2232. The study includes multiple parts evaluating different dosing schedules and combinations to assess how the treatments work individually and together. All treatments are given by injection under the skin. Throughout the study, researchers will monitor the frequency of any adverse events for up to 12 months. They will also measure the percentage change in body weight from the start of the study up to 6 months. Participants will undergo regular assessments including safety evaluations, laboratory tests, and other measurements to track the effects and safety of the treatments during the study period.

Researchers are evaluating ALN-4324 in overweight to obese adults, including healthy volunteers and patients with type 2 diabetes mellitus (T2DM). This two-part Phase 1/2 study aims to assess the safety, tolerability, and pharmacokinetics of single ascending doses in healthy volunteers and the efficacy, safety, tolerability, and pharmacodynamics of multiple doses in patients with T2DM. The trial focuses on understanding how ALN-4324 works and its effects in these groups. ALN-4324 and placebo are both given as subcutaneous injections. In Part A, single doses of ALN-4324 are administered to overweight to obese healthy volunteers to evaluate safety and drug behavior over up to 9 months. Part B involves multiple doses given to overweight to obese patients with T2DM, with monitoring up to 12 months to study effects on diabetes and overall safety. During the study, participants will undergo regular assessments to monitor safety and tolerability, including tracking any adverse events. The study also measures pharmacokinetics and pharmacodynamics to understand the drug's action in the body. Participants' body mass index, diabetes control, and medication use will be closely observed. The trial includes a placebo group for comparison and lasts up to 12 months depending on the study part.

Researchers are studying ALN-6400 to evaluate its safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy adult volunteers and adult patients with Hereditary Hemorrhagic Telangiectasia (HHT). The study includes both phase 1 and phase 2 components, aiming to understand how single and multiple doses of ALN-6400 perform in these groups. The study has two parts: Part A involves administering single ascending doses of ALN-6400 subcutaneously to healthy volunteers, while Part B involves giving multiple doses of ALN-6400 subcutaneously to adult patients diagnosed with HHT. A placebo is also used in both parts for comparison. Both groups will be monitored to assess how the drug is processed in the body and its effects. Participants will be involved in safety monitoring, including tracking the frequency of adverse events up to 36 weeks in Part A and up to 96 weeks in Part B. The study also evaluates pharmacokinetics, pharmacodynamics, and tolerability throughout the treatment periods. Participants must meet specific health and laboratory criteria, and adherence to contraceptive requirements is required during the study.

Researchers are evaluating the safety and effectiveness of brenipatide at different doses compared with a placebo in adults with uncontrolled moderate to severe asthma. This Phase 2 study focuses on participants who have a history of asthma requiring controller medication and recent severe asthma exacerbations. The goal is to better understand how brenipatide impacts asthma control over an extended period. Participants will receive either brenipatide or a placebo, both administered by subcutaneous injection. The study includes a 52-week treatment period during which the effects of the drug on asthma exacerbations and symptoms will be monitored. This randomized, double-blind approach helps compare the responses between the treatment and placebo groups. Study involvement lasts about 65 weeks, covering screening, treatment, and follow-up phases. During the study, researchers will assess participants' asthma control using questionnaires and track the annual rate of asthma exacerbations. Safety and treatment responses will be closely monitored throughout the trial to evaluate the drug's impact and participant well-being.

Researchers are evaluating the safety and effectiveness of tezepelumab in adults aged 40 to 80 years with moderate to very severe chronic obstructive pulmonary disease (COPD). These participants must have a history of COPD for at least one year and have experienced multiple COPD exacerbations despite using inhaled maintenance therapy. This Phase 3, multicenter, randomized, double-blind, placebo-controlled study focuses on those who have had at least two moderate or one severe exacerbation in the prior year while on inhaled triple or dual therapy. Participants will receive monthly subcutaneous injections of either one of two doses of tezepelumab or a placebo. Treatment will last for a minimum of 52 weeks and up to 76 weeks. After the treatment period, there will be a 12-week off-treatment safety follow-up to monitor any lasting effects or safety concerns. During the study, researchers will assess the participants' lung function and monitor the annual rate of moderate or severe COPD exacerbations. Participants will undergo screening to confirm eligibility based on lung function tests, eosinophil counts, and symptom scores. Safety will be closely monitored throughout the treatment and follow-up periods to evaluate adverse effects and overall participant health.

Researchers are evaluating the effects of single and multiple doses of ABCL635, given by subcutaneous injection, in healthy men and postmenopausal women, including those with moderate-to-severe vasomotor symptoms (VMS) related to menopause. This study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ABCL635, as well as its impact on the frequency and severity of VMS in affected postmenopausal women. The study includes both healthy volunteers and women experiencing menopausal symptoms to understand the treatment's effects across these groups. The study has three parts: Part A and Part B are Phase 1 studies involving single ascending doses and multiple ascending doses of ABCL635 or placebo, respectively, given to healthy men and postmenopausal women. Part C is a Phase 2 study where a single dose of ABCL635 or placebo is given to postmenopausal women with moderate-to-severe VMS. After completing Part C, participants may join an open-label extension to receive an additional single dose of ABCL635 following a 12-week evaluation period. Participants will be monitored from day 0 to day 197 for safety outcomes including frequency and severity of adverse events, abnormalities in ECGs, physical examinations, and laboratory tests covering biochemistry, hematology, endocrinology, and urinalysis. The study involves thorough health assessments, breast cancer screening for women, and hormone level checks for men. Researchers will measure how the treatment affects menopausal symptoms and overall participant health throughout the study and extension period.