Cypress

Researchers are studying a new medicine called Inno8 to understand how eating and drinking before and after taking it affect its absorption in the stomach. This study focuses on healthy male participants aged 18 to 45 years with specific body weight and body mass index ranges. It is a Phase 1 study designed to evaluate Inno8's pharmacokinetic properties, particularly how food intake influences these properties in the body. Participants will take a single oral dose of Inno8 after fasting overnight, with fasting durations varying depending on the group they are assigned to. After taking the medicine, participants will fast again. The study is divided into four groups, each with different meal timing schedules relative to the dose. The entire study lasts up to 9.5 weeks. During the study, researchers will monitor the concentration of Inno8 in the blood from the first dose until day 17. Participants will undergo medical history reviews, physical exams, vital sign measurements, ECGs, and lab tests to ensure health status. Safety and drug absorption will be closely observed throughout the study period.

This research aims to evaluate the safety and effectiveness of UBT251 in adults living with overweight or obesity. The study includes participants aged 18 to 65 years, depending on the specific part of the trial, and focuses on those with a body mass index (BMI) within certain ranges for each part. It is a Phase 2 clinical trial designed to compare UBT251 with a placebo to understand its impact on weight and safety in this population. Participants will receive either UBT251 or a placebo, both administered as injections under the skin of the abdominal area. The dosing details vary by study part, with eligibility criteria including specific BMI ranges and age limits for each group. The study includes multiple parts with different timelines, including a treatment period and follow-up visits to monitor effects and safety. Throughout the study, participants will be monitored for treatment-emergent adverse events from baseline to the end of the study, changes in body weight, and drug concentration levels in the blood. Assessments include medical history, physical exams, vital signs, ECG, and laboratory tests. The total study duration varies by part but involves careful observation to evaluate safety, tolerability, and efficacy of the treatment over several weeks.

Researchers are evaluating how well the combination of MET233 and MET097 works to treat adults who are overweight or have obesity, with some participants also having type 2 diabetes. This randomized, placebo-controlled, double-blind study aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of these subcutaneous medications in adults with a BMI between 27 and 38 kg/m2. Participants include adults with obesity or overweight without diabetes in Parts A and B, and those with type 2 diabetes in Part C. The study has three parts. Part A involves one dose of the study drug followed by a 12-week safety follow-up after up to a 4-week screening period. Parts B and C include 12 weekly doses of the study drug with an approximately 11-week safety follow-up after the last dose, also following a screening period of up to 4 weeks. Participants will receive either the combination of MET233 and MET097 or placebo via subcutaneous injections during these periods. Participants will be closely monitored throughout the study with assessments including treatment-emergent adverse events tracked from baseline to Day 85 in Part A and to Day 155 in Parts B and C. Safety evaluations, physical exams, and laboratory tests will be conducted during the screening, treatment, and follow-up periods to ensure participant well-being and to measure the study drugs' effects over the duration of participation.

Researchers are conducting a Phase 1 clinical trial to evaluate the safety, tolerability, and pharmacokinetics of a drug called SPY002-072 in healthy adults aged 18 to 60 years. This study is randomized, double-blind, placebo-controlled, and involves a single dose of the investigational drug or placebo. The trial aims to gather initial safety data in humans for SPY002-072. Participants will receive either the experimental drug SPY002-072 or a placebo in a controlled setting. The study design includes a single ascending dose administration, meaning doses may increase in a stepwise manner for different participant groups to monitor safety and drug behavior in the body. The trial includes a confinement period at the research unit where participants stay during treatment, followed by outpatient visits. During the study, participants will undergo various tests and evaluations to monitor for treatment-emergent adverse events up to 40 weeks after dosing. Researchers will assess safety and how the drug is processed in the body through these visits and tests. Participants are required to comply with all study procedures and attend scheduled visits to ensure thorough monitoring throughout the trial.

Researchers are conducting a Phase 1 study to evaluate the safety, tolerability, and how the body processes a drug called SPY002-091 in healthy adults. This study is designed as a randomized, double-blind, placebo-controlled trial where participants receive a single dose of the drug or a placebo. The goal is to understand how well participants tolerate the drug and to gather initial safety information. Participants will receive one dose of either SPY002-091 or a placebo. The study uses a single ascending dose design, meaning doses may be adjusted in different groups to assess effects. The study is carefully controlled to ensure neither participants nor researchers know who receives the drug or placebo during the trial. During the study, participants will need to come to the clinical research unit (CRU) for visits and stay at the site during the confinement period. They will be monitored closely for any side effects or adverse events for up to 40 weeks. Researchers will track treatment-emergent adverse events and collect data on safety and how the drug moves through the body. Participants must be able to comply with all testing and visit requirements throughout the study.

Researchers are evaluating how oral emraclidine is processed in the bodies of healthy elderly adults and assessing its safety and tolerability. This Phase 1 study focuses on participants aged 65 to 85 years who are in general good health. The goal is to understand how the drug moves through the body and to monitor any adverse effects that may occur during the study period. Participants receive multiple ascending doses of oral emraclidine or a matching placebo in a randomized, placebo-controlled design. The study examines the pharmacokinetics of emraclidine, including measures such as plasma concentration and metabolite ratios, during up to approximately 20 days of dosing. The study also tracks adverse events and other safety parameters related to the drug’s effects. Throughout the study, participants undergo medical history reviews, physical exams, vital sign monitoring, laboratory tests, ECGs, and assessments of movement and mental health scales. Researchers measure changes from baseline in these parameters and analyze drug concentration levels in the blood. The study period lasts up to about 50 days to capture adverse events and other safety data, helping to evaluate the drug’s overall safety and tolerability in this population.

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 investigating how the length of fasting and temporarily stopping Glucagon-Like-Peptide 1 (GLP-1) medications affect the amount of food left in the stomach. This study focuses on people using liraglutide (injected), semaglutide taken by mouth, or semaglutide injected. The research is conducted in a Phase 1 clinical trial setting and includes participants with obesity who are already on maintenance treatment with these medications. Participants will receive either liraglutide by injection, oral semaglutide, or semaglutide by injection according to their current treatment. The study observes the effects of these treatments on stomach emptying following a solid, high-fat meal after different durations of fasting. The timing of fasting and medication dosing is carefully monitored to assess its impact on gastric contents. During the study, participants will undergo assessments involving ultrasound scans to measure stomach contents at several time points after fasting begins (6, 8, 10, 12, 18, and 24 hours). Researchers will also monitor participant safety and adherence to treatment schedules. The total duration of participation depends on the type of GLP-1 receptor agonist treatment already in use by the participant.

Researchers are studying SBS-147, an experimental drug, to understand its safety and how the body processes it in healthy adults aged 18 to 55 years. The study compares SBS-147 to a placebo to observe any side effects and to evaluate its effects related to acute pain. This Phase 1 trial is part of the HEAL Initiative supported by the NIH and focuses on assessing safety and tolerability. The trial has two parts: a Single-Dose Group where participants receive either SBS-147 or placebo one time, and a Multiple-Dose Group where participants receive either SBS-147 or placebo once or twice daily for 7 days. Participants in the single-dose portion stay in the clinic for 5 days, while those in the multiple-dose portion stay for 10 days. Both groups undergo tests, blood draws, and questionnaires during their stay. Participants complete an end-of-study visit either on Day 8 for the single-dose group or Day 14 for the multiple-dose group. Researchers monitor treatment-related side effects using CTCAE v5.0 criteria and collect safety data at specific time points. The study tracks adverse events and evaluates tolerability throughout the treatment period and follow-up visits.