Hubei Renfu Chengtian Pharmaceutical Co., Ltd.

Primary objective: To evaluate the safety and tolerability of HZ-J001 cream in healthy adult subjects, and to provide a safety basis for determining the dosage and area of administration used in later trials. Secondary objective: To evaluate the systemic exposure level and pharmacokinetic characteristics of 1.0%, 1.5%, and 2.0% HZ-J001 cream in healthy adult subjects after single and multiple topical skin administration.

The desonide cream produced by Hubei Renfu Chengtian Pharmaceutical Co., Ltd. was used as the test preparation, and the desonide cream (0.05%, Perrigo®) certified by Perrigo New York Inc. was used as the reference preparation. The in vivo exposure ratio of the test preparation and the reference preparation after local administration was studied to evaluate the safety of the test preparation.

1) Using the leprocaine cream of Hubei Renfu Chengtian Pharmaceutical Co., Ltd. as the test preparation and the leprocaine cream (Enna®/EMLA®) of Aspen Pharma Trading Limited as the reference preparation, the pharmacokinetic behavior of leprocaine cream in healthy Chinese subjects was compared and the bioequivalence of the two preparations was evaluated. 2) Evaluate the safety of the test preparation leprocaine cream in healthy Chinese subjects.