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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06229548 | A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SYH2053 | PHASE1 | COMPLETED | 39 | — | — | Jan 8, 2024 | Mar 25, 2025 | Apr 4, 2025 | 1 | China |
The investigator will make an assessment of intensity for each AE and SAE reported during the study according to CTCAE V5.0
| Arm | Type | Description |
|---|---|---|
| SYH2053 SAD experimental group | EXPERIMENTAL | Subjects in SAD experimental groups will receive a single subcutaneous injection of SYH2053 on Day 1. |
| Placebo SAD group | PLACEBO_COMPARATOR | Subjects in SAD placebo groups will receive a single subcutaneous injection of placebo on Day 1. |
| Name | Type | Description |
|---|---|---|
| SYH2053 | DRUG | subcutaneous injection |
| Placebo | DRUG | subcutaneous injection |
Inclusion Criteria: 1. Subjects must give informed consent before the trial, fully understand the content, procedures and possible adverse reactions, and voluntarily sign a written informed consent. 2. Sex: male or female subjects. 3. Age of 18 - 60 years (inclusive). 4. BMI: 18.6-28.5 kg/m\^2 (inc...