Dilworth

Researchers are evaluating the safety, tolerability, and how the body processes the drug JPH034 in healthy adults aged 18 to 50 years. This Phase 1 study is randomized, double-blind, and placebo-controlled and also includes a pilot evaluation of how food affects the drugs behavior in the body. The study aims to identify any side effects and understand how JPH034 and its main metabolite, M1, are absorbed and eliminated. Participants will be randomly assigned to receive a single oral dose of JPH034 or a placebo in different dose groups. The single-ascending dose SAD groups receive one dose under fasting conditions and stay confined for 48 hours for monitoring. A subset of participants will return for a pilot food effect evaluation, receiving JPH034 after a high-fat meal to study how food influences drug exposure. Safety review committees will monitor data to determine dose escalation and safety. During the study, participants undergo physical exams, vital sign checks, ECGs, and laboratory tests to monitor safety. Blood and urine samples are collected to measure drug levels up to 96 hours after dosing. Follow-up visits occur 7 to 9 days later to check for adverse events and overall health. The study includes detailed safety assessments such as heart rate, blood pressure, respiratory rate, body temperature, and ECG QTc intervals to ensure participant safety throughout the trial.

This research aims to evaluate the safety and tolerability of mirikizumab LY3074828 when given as a single injection compared to two separate injections under the skin in healthy adult volunteers aged 18 to 65 years. The study is conducted in a Phase 1 setting to understand how the body processes the drug through blood tests. The trial is sponsored by Eli Lilly and Company and includes healthy participants without significant medical conditions. Participants will receive mirikizumab administered subcutaneously in one of three experimental arms. The study is randomized and open-label, comparing different injection methods of the same drug. The treatment period is followed by monitoring to assess pharmacokinetics, including maximum concentration and drug exposure over time. Throughout approximately 15 weeks, volunteers will undergo medical evaluations such as physical exams, laboratory tests, ECGs, and vital sign monitoring. Blood samples will be collected to measure drug levels and how the body absorbs and eliminates the study medication. Safety and tolerability assessments will continue during this period to ensure participant well-being.

This research aims to study the levels of two drugs, povorcitinib taken by mouth and ruxolitinib cream applied to the skin, in the body fluids of healthy adults. The study focuses on measuring how these drugs distribute in the skin and blood after multiple doses. It is a phase 1 trial to better understand the pharmacokinetics, or how the drugs move and change within the body. Participants will receive either povorcitinib tablets at doses defined by the study or ruxolitinib cream applied twice daily to the skin. The study includes three groups, two receiving povorcitinib and one receiving ruxolitinib cream. The treatments are given over a period of up to 12 days, during which drug levels in skin fluid and blood will be collected and analyzed. During the study, participants will be closely monitored through various tests including blood draws and skin fluid sampling using an open-flow microperfusion device. Researchers will measure peak concentrations, area under the curve, and other pharmacokinetic parameters up to day 12. Safety will be assessed by tracking any adverse events until day 28. The total participation duration includes dosing and follow-up assessments to understand drug behavior and safety in healthy adults.