Phase 1 Study to Evaluate Safety and Effects of Single Doses of JPH034 in Healthy Adults Ages 18 to 50

What this Trial Is About

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.

A Study of JPH034 in Healthy Adult Participants