Dilworth

Researchers are evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single-ascending doses of JPH034, a drug being tested in healthy adult participants aged 18 to 50 years. This Phase 1, randomized, double-blind, placebo-controlled study includes a pilot food effect evaluation to understand how a high-fat meal influences the drug's absorption and behavior in the body. The study focuses on identifying side effects and monitoring health through physical exams, vital signs, ECGs, and lab tests.

This research aims to evaluate the safety and tolerability of mirikizumab (LY3074828) given as a single injection compared to two injections under the skin in healthy adult participants. The study focuses on how the body processes the drug by examining blood test results. It is a Phase 1 trial involving healthy adults aged 18 to 65 years. Participants will receive mirikizumab subcutaneously either as one injection or two separate injections. The study includes an adaptive two-stage design to compare these two methods of administration. The treatment period involves careful monitoring to assess the drug's absorption and overall exposure in the body. During the approximately 15-week study, participants will undergo medical evaluations including blood tests, ECGs, and vital sign monitoring to track safety and how the drug behaves in the body. The main outcomes measured are the maximum concentration and the area under the concentration-time curve of mirikizumab from Day 1 through Day 71. Participants are closely observed throughout to ensure safety and gather detailed pharmacokinetic data.

Researchers are evaluating the concentrations of two drugs, povorcitinib taken by mouth and ruxolitinib cream applied to the skin, using a special device called an open-flow microperfusion. This study focuses on healthy adults aged 18 to 65 years and aims to measure how much of these drugs reach the skin and bloodstream after multiple doses. It is a Phase 1 study designed to understand the pharmacokinetics, which means how the drugs move through and are processed by the body. Participants will receive either oral povorcitinib tablets or topical ruxolitinib cream over a period that includes up to 12 days of dosing. The open-flow microperfusion device will be used to sample the drug levels in the skin's interstitial fluid, while blood samples will be collected to measure drug levels in the plasma. This approach helps researchers compare how the drugs behave in different body compartments after repeated doses. During the study, participants will undergo clinical evaluations, laboratory tests, ECGs, and skin assessments to ensure safety and monitor drug effects. Researchers will measure key pharmacokinetic parameters such as maximum drug concentration and area under the curve in both skin fluid and plasma up to Day 12. The study includes close monitoring for adverse events and requires participants to follow specific guidelines about skin care, sun exposure, and activity to maintain study conditions. Overall participation will last through the treatment and observation periods defined by the study protocol.