A Study of SGB-3383 in Healthy Subjects

Suzhou Sanegene Bio

Status and phase: Not yet enrolling; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: SGB-3383-Matching placebo; Drug: SGB-3383

Study type: Interventional

Funder types: Industry

Identifiers

NCT06995326

SGB-3383-002

Details and patient eligibility

About

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.

Enrollment: 37 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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37 participants in 2 patient groups, including a placebo group

SGB-3383

Experimental group

Description:

SGB-3383 for sc injection

Treatment:

Drug: SGB-3383

SGB-3383-Matching placebo

Placebo Comparator group

Description:

Normal saline (0.9% NaCl) matching volume of SGB-3383 doses will be administered

Treatment:

Drug: SGB-3383-Matching placebo