A Study of SGB-3383 in Healthy Subjects

A Phase 1, Randomized, Double-blind, Placebo-controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered SGB-3383 in Healthy Volunteers

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of SGB-3383 in healthy subjects. The study will be designed as a single ascending dose (SAD) phase, utilizing a double-blind, placebo-controlled approach.

Inclusion Criteria:

• Weight ≥ 45.0 kg (female) or ≥ 50.0 kg (male), and Body Mass Index (BMI) within the range of 18.0 to 28.0 kg/m², inclusive
• Physical examination, vital signs, 12-lead electrocardiogram, and laboratory tests be normal or slightly abnormal but not clinically significant according to investigator's judgement.
• Participants must agree to use adequate contraception from signing the informed consent until 3 months after completion of the follow-up visit.
• Willing to comply with the protocol required visit schedule and visit requirements and provide written informed consent.

Exclusion Criteria:

• A history of or a current surgical or medical condition that, in the opinion of the Investigator, may put the subject at significant risk (according to Investigator's judgment) or interfere with the subject's participation in the clinical study.
• History of meningococcal infection, or subjects from occupations or living environment at risk of Neisseria meningitidis exposure.
• Positive result of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), human immunodeficiency virus (HIV) antibody, or syphilis at screening.
• Alanine aminotransferase (ALT), total bilirubin (TBIL), aspartate aminotransferase (AST)> 1.5 × ULN, and deemed clinically significant by the Investigators
• QTcF values > 450 ms for male, and > 470 ms for female