Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07300436 | A Study of TJ101 Injection Before and After CMC Change Following Subcutaneous Injection in Healthy Adult Male Subjects in China | PHASE1 | RECRUITING | 96 | — | — | Jan 4, 2026 | Jun 1, 2026 | Jan 30, 2026 | 1 | China |
Maximum Concentration
Area Under the Concentration-Time Curve from Time Zero to Infinity
| Arm | Type | Description |
|---|---|---|
| Group A（T-R） | EXPERIMENTAL | - |
| Group B（R-T） | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TJ101 injection Test Product | DRUG | 1.2 mg/kg, administered by subcutaneous injection in the abdomen,Once per cycle |
| TJ101 injection Reference Product | DRUG | 1.2 mg/kg, administered by subcutaneous injection in the abdomen,Once per period |
Inclusion Criteria: * Male subjects aged ≥ 18 and ≤ 45 years; * Body mass index (BMI): 19-28 kg/m2 (inclusive), weight 50-90 kg (inclusive), with BMI calculated as: BMI = weight (kg) / height2 (m2); * Results of physical examination, vital signs, laboratory tests, 12-lead ECG, chest X-ray (posteroa...