Clinical trials

This study is a randomized, double-blind, multicenter, placebo parallel-controlled Phase II clinical study designed to evaluate the clinical efficacy and safety of TJ0113 Capsule in patients with sarcopenia. The entire study plans to enroll 204 participants with sarcopenia. Eligible participants will be stratified by age (\< 70 years or ≥ 70 years to ≤ 80 years or \> 80 years) and block-randomized in a 1:1:1:1 ratio into 4 groups (TJ0113 Capsule 100 mg dose group; TJ0113 Capsule 200 mg dose group; TJ0113 Capsule 400 mg dose group; placebo group), with 51 participants per group. Participants in the placebo group will then be re-randomized in a 1:1:1 ratio to the respective dose groups (100 mg, 200 mg, and 400 mg). After randomization, study participants will receive continuous oral administration for 26 weeks with efficacy and safety evaluations, followed by a 1-week follow-up period after the end of treatment.

This study is a phase II, randomized, double-blind, multi-center, placebo-controlled, parallel-group clinical trial and 150 subjects with depressive disorder will be enrolled. Subjects will be randomly assigned in a 1:1 ratio to two cohorts (Cohort 1: 200 mg dose group; Cohort 2: 400 mg dose group). Within each cohort, subjects will be randomized in a 2:1 ratio to either the TJ0113 capsule group or the placebo group, with approximately 50 subjects receiving TJ0113 capsules and approximately 25 receiving placebo. Approximately 50 subjects will be enrolled in each of the TJ0113 capsule 200 mg group, TJ0113 capsule 400 mg group, and placebo group in this trial. Eligible subjects will be randomly assigned to receive continuous oral administration for 8 weeks, after which efficacy and safety will be evaluated, followed by an additional 1-week follow-up period after the end of treatment.