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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06067490 | A Phase I Study of RC1416 Injection | PHASE1 | COMPLETED | 48 | — | — | Jun 29, 2023 | May 14, 2024 | Dec 2, 2024 | 1 | China |
incidence ,severity and relation to investigational drugs of Adverse Events according to CTCAE V5.0
number of praticipants with clinically notable Vital Signs according to CTCAE V5.0
number of praticipants with clinically notable Laboratory Tests according to CTCAE V5.0
number of praticipants with clinically notable Electrocardiogram(ECG) Values according to CTCAE V5.0
number of praticipants with clinically notable Injection Site Reaction according to CTCAE V5.0
| Arm | Type | Description |
|---|---|---|
| RC1416 | EXPERIMENTAL | RC1416(SAD),single ascending (25mg-600mg) of RC1416 by subcutaneous injection |
| Placebo | PLACEBO_COMPARATOR | Placebo(SAD), Each subjects will receive the placebo once by subcutaneous injection. |
| Name | Type | Description |
|---|---|---|
| RC1416(SAD) | DRUG | RC1416(SAD),there are six doses(25mg-600mg) in this part. Each subjects will receive the drug once by subcutaneous injection. |
| Placebo(SAD) | DRUG | Placebo(SAD), Each subjects will receive the placebo once by subcutaneous injection. |
Inclusion Criteria: * Male or female aged 18 to 50 years(including the boundary value)，Chinese. * Male Weight of 50 kg to 90 kg，femal weight of 40kg to 90kg, and BMI of 19.0 to 28.0 kg/m2 (including the boundary value). * Subject have no fertility, sperm/egg donation plan for at least 6 months from...