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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06995326

Enrollment

Registered

2025-05-29

Start date

2025-06-30

Completion date

2027-01-31

Last updated

2025-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

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.

Interventions

DRUGSGB-3383

SGB-3383 for sc injection, single dose

DRUGSGB-3383-Matching placebo

SC injection, single dose

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Number of Participants with Adverse Events (AEs)	up to approximately 12 months

Secondary

Measure	Time frame
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

Contacts

Primary ContactSGB.clinical

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026