Bioequivalence Study of WP205 in Healthy Subjects

Launched by WANBANGDE PHARMACEUTICAL GROUP CO., LTD ·

Keywords

ClinConnect Summary

This early-phase study is designed to see if two versions of a methylcobalamin (vitamin B12) injection behave the same in the body. It’s a small, single-center, randomized, open-label crossover trial in healthy adult volunteers who fast before dosing. Each participant will receive both injections in different orders: one period gets the test product first, and the other period gets the standard reference product first, with a washout gap between doses. Each dose is a 25 mg intramuscular shot in the upper arm. Researchers will measure drug levels in the blood for up to 24 hours after each dose to determine bioequivalence—whether the two products reach similar amounts in the blood and at similar speeds. Safety is monitored for about a week after dosing.

Who may participate? Adults 18 years and older who are healthy, with a BMI between 19 and 26 and meeting certain weight criteria, and who can give informed consent. Key exclusions include known allergy to methylcobalamin or components, significant medical illnesses, recent vaccination, pregnancy or breastfeeding, and use of medications or substances that could affect the study results. The study is currently not recruiting and plans to start around mid-September 2025, enrolling about 14 people, with completion planned for the end of September 2025. If you’re seeking more information, you can contact the study team.

Gender

ALL

Eligibility criteria