Clinical Trial: A Study of TJ101 Injection Before and After CMC Change Following Subcutaneous Injection in Healthy Adult Male Subjects in China

U.S., Dec. 24 -- ClinicalTrials.gov registry received information related to the study (NCT07300436) titled 'A Study of TJ101 Injection Before and After CMC Change Following Subcutaneous Injection in Healthy Adult Male Subjects in China' on Dec. 10.

Brief Summary: This is Single-center, randomized, open-label, single-dose, three-period or two-period crossover study design.

The goal of the stage 1 is to preliminary evaluate the PK comparability of TJ101 injection before and after CMC change following a single subcutaneous injection of 1.2 mg/kg in healthy male subjects in China, and to assess whether the two formulations are bio equivalent.

The goal of the stage 2 is to further evaluate the PK comparability of TJ101 injection before and a...