A First-in-Human Study of SGB-9768 in Healthy Volunteers

INTERVENTION: Treatment: Drugs ‐ SGB‐9768 6 Cohorts: 25mg, 50mg, 100mg, 200mg, 400mg and 800mg The duration of administration: single dose SGB‐9768 will be administered via subcutaneous injection by a registered nurse The used and/or partially used vials can be disposed of per local practice. If the used and/or partially used vials cannot be disposed of at the site, they will be returned, along with the unused vials, to the sponsor or its agent after receipt of written authorization from the Sponsor. CONDITION: Complement‐mediated Diseases; ; Complement‐mediated Diseases Inflammatory and Immune System ‐ Other inflammatory or immune system disorders PRIMARY OUTCOME: Safety and tolerability [Assessed by the incidence of adverse events as evaluated by triplicate 12‐lead ECG, physical examination, vital signs (pulse rate and blood pressure by electronic sphygmomanometer, temperature using an aural thermometer, respiratory rate by counting), laboratory safety tests by blood sample collection for assessment of chemistry and hematology, coagulation and urine sample for urinalysis. Baseline, 2, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 131, 141, and 169 days after intervention commencement, and 225, 281, 337 days after intervention commencement if C3 level has not reached 60% of baseline and below normal range.] SECONDARY OUTCOME: Pharmacodynamic effect[serum complement C3 level Predose, 3, 5, 8, 15, 22, 29, 43, 57, 71, 85, 113, 141, 169 days after intervention commencement. And 225, 281, 337 days after intervention commencement if C3 level has not reached 60% of baseline and below normal range.] Pharmacokinetic paremeters[Plasma pharmacokinetics parameters include, but not limited to, maximum concentration (Cmax), time to maximum concentration (Tmax), the area under the curve (AUC) from time 0 to the last measurable concentration (AUC0‐last), AUC from time 0 to infinity (AUC0‐inf), and apparent terminal elimination half‐life (t½). Urine pharmacokinetics parameters include, but not limited to, the cumulative amount of drug excreted in urine (Ae), fraction of drug recovered in urine (Fe), and renal clearance (CLr). 0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48h post‐dose] INCLUSION CRITERIA: 1. Male and female subjects aged 18 to 55 years are included at the time of informed consent. 2. Body mass inde Xbetween 18 and 32 kg/m2 at screening, inclusive. 3. Physical examination, vital signs, 12‐lead electrocardiogram, and laboratory tests be normal or slightly abnormal but not clinically significant according to Investigator’s judgement. 4. Healthy volunteers must be willing to be vaccinated for Neisseria meningitidis (both meningococcal group ACWY conjugate vaccine and meningococcal group B vaccine), Haemophilus influenzae, and Streptococcus pneumoniae before dosing, and willing to receive prophylactic antibiotics as required in the protocol. 5. Female subjects must be non‐pregnant or non‐lactating. 6. Women of child‐bearing potential who are not exclusively in same‐se Xrelationships and males with partners of child‐bearing potential must agree to use adequate contraception (As described in Appendi X1) from signing the informed consent