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NCT Number: NCT06995326

A Study of SGB-3383 in Healthy Subjects

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SGB-3383

Drug

SGB-3383 for sc injection, single dose

SGB-3383-Matching placebo

Drug

SC injection, single dose

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: up to approximately 12 months

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of SGB-3383

    Time frame: Up to Day 3

  2. Area Under the Concentration-time Curve (AUC) of SGB-3383

    Time frame: Up to Day 3

Study contacts

Contact information is provided by the study sponsor or research team.

SGB.clinical

CONTACT

[email protected]

+086 021-60209828

Sponsors and collaborators

Lead sponsor

Suzhou Sanegene Bio Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
May 29, 2025
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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