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.
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;
Healthy male or female subjects, aged 18 to 55 years (inclusive);
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;
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;
History and/or current presence of clinically significant medical conditions, including but not limited to circulatory system disorders, hematological or hematopoietic system disorders, respiratory disorders, endocrine disorders, urinary system disorders, digestive system disorders, neurological or psychiatric disorders, autoimmune diseases, malignant tumors, severe trauma, or any other disease that should be excluded or may interfere with the interpretation of the study results in the opinion of the investigator;
History of splenectomy, or functional or anatomical asplenia;
Known or suspected hereditary or acquired complement deficiency or impaired complement activity, or complement activity below the normal range at screening;
History of meningococcal infection, or positive Neisseria meningitides test at screening;
Parallel
SYH2061
Drugsubcutaneous injection
Placebo
Drugsubcutaneous injection
Number of Subjects with Adverse Events as Assessed by CTCAE v5.0
To assess the safety and tolerability of SYH2061 in healthy subjects
Maximum observed plasma concentration (Cmax) of SYH2061
To characterize the Cmax of SYH2061 in healthy subjects
Time to maximum observed plasma concentration (Tmax) of SYH2061
To characterize the Tmax of SYH2061 in healthy subjects
Area under the concentration-curve from zero to the last quantifiable concentration (AUClast) of SYH2061
To characterize the AUClast of SYH2061 in healthy subjects
Area under the concentration-time curve from zero to infinity (AUCinf) of SYH2061
To characterize the AUCinf of SYH2061 in healthy subjects
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