A Study of SGB-3383 in Healthy Subjects

NCT06995326 | Not Yet Recruiting Phase 1

• 1 other identifier: SGB-3383-002
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events (AEs)

  up to approximately 12 months

Secondary Outcomes (2)

• 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

Study Arms (2)

SGB-3383

EXPERIMENTAL

SGB-3383 for sc injection

Drug: SGB-3383

SGB-3383-Matching placebo

PLACEBO COMPARATOR

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

Drug: SGB-3383-Matching placebo

Interventions

SGB-3383 DRUG

SGB-3383 for sc injection, single dose

SGB-3383

SGB-3383-Matching placebo DRUG

SC injection, single dose

SGB-3383-Matching placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Suzhou Sanegene Bio Inc.: lead

Central Study Contacts

SGB.clinical

CONTACT

+086 021-60209828; SGB.clinical@sanegenebio.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: June 3, 2025

Record last verified: 2025-05