A Study of SGB-3383 in Healthy Subjects

Phase 1

Not yet recruiting

• Conditions: Healthy Volunteers
• Interventions: Drug: SGB-3383; Drug: SGB-3383-Matching placebo

• Registration Number: NCT06995326
• Lead Sponsor: Suzhou Sanegene Bio Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-20
• Study First Submitted QC: 2025-05-20
• Last Update Submitted: 2025-05-28
• Study First Posted: 2025-05-29
• Study Start: 2025-06
• Last Update Posted: 2025-06-03
• Primary Completion: 2026-08
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 37

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SGB-3383	SGB-3383	SGB-3383 for sc injection
SGB-3383-Matching placebo	SGB-3383-Matching placebo	Normal saline (0.9% NaCl) matching volume of SGB-3383 doses will be administered

Primary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events (AEs)	up to approximately 12 months

Secondary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) of SGB-3383	Up to Day 3
Area Under the Concentration-time Curve (AUC) of SGB-3383	Up to Day 3