A Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and P
This is a randomized, double-blind, placebo-controlled, single-ascending dose study in healthy subjects to evaluate the safety, tolerability, PK, and PD of SYH2061.
| Condition(s) | Healthy Subjects |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | This is a randomized, double-blind, placebo-controlled, single-ascending dose study in healthy subjects to evaluate the safety, tolerability, PK, and PD of SYH2061. |
| Who can participate | Inclusion Criteria: 1. Subjects must be informed of the study before it begins, fully understand the study content, procedures, and potential adverse reactions, and voluntarily sign the written ICF; 2. Healthy male or female subjects, aged 18 to 55 years (inclusive); 3. Body mass index ranging from 19.0 to 28.0 kg/m2 (inclusive), with a body weight of ≥ 50 kg for males and ≥ 45 kg for females; 4. The results of various examinations, such as physical examination, vital signs, ECG, chest X-ray, abdominal B-scan ultrasound, and laboratory tests at screening are normal or abnormal without clinical significance; 5. Vaccinated against meningococcal ACYW135 vaccine and pneumococcal vaccine at least 14 days prior to the first dose, or have valid documentation of receiving the respective vaccinatio |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. |
| Locations | Hefei, Anhui, China |
| Start date | 2025-12-23 |
| NCT ID | NCT07241910 |
| Official listing | https://clinicaltrials.gov/study/NCT07241910 |