Phase 1 Study Evaluating Safety and Bioavailability of DWRX5003 Compared to DWC202502 and DWC202503 in Healthy Adults

What this Trial Is About

Researchers are conducting a Phase 1 clinical trial to evaluate the safety and relative bioavailability of DWRX5003, a microneedle patch containing Semaglutide, in healthy adult volunteers aged 19 to 64 years. This trial compares DWRX5003 with two active comparator drugs, DWC202502 and DWC202503, as well as a placebo microneedle patch, to better understand how these treatments behave in the body. Participants receive one of three doses of DWRX5003 or comparator treatments in a randomized and double-blind sequence. The study measures how the drug is absorbed and processed over 672 hours following a single dose. The trial focuses on pharmacokinetic outcomes including the area under the curve AUC and maximum concentration Cmax, alongside other related measures. Volunteers will undergo screenings including medical exams, laboratory tests, vital signs, physical exams, and ECGs before participation. During the study, researchers monitor drug levels and related biological factors over time to assess safety and drug availability. The study is expected to be completed by November 2026, with participants carefully observed during and after the dosing period to gather comprehensive safety and pharmacokinetic data.

A Phase 1 Clinical Trial to Assess the Safety of DWRX5003 and Relative Bioavailability to DWC202502 and DWC202503 in Healthy Adult Volunteers