A Study of SGB-3383 in Healthy Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SGB-3383, SGB-3383-Matching placebo.
- Who it may be relevant to
- Registry conditions: Healthy Volunteers. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
- Drug SGB-3383
SGB-3383 for sc injection, single dose - Drug SGB-3383-Matching placebo
SC injection, single dose
Primary outcome measures
- Number of Participants with Adverse Events (AEs) [Time frame: up to approximately 12 months]
Secondary outcome measures (2)
- Maximum Observed Plasma Concentration (Cmax) of SGB-3383 [Time frame: Up to Day 3]
- Area Under the Concentration-time Curve (AUC) of SGB-3383 [Time frame: Up to Day 3]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06995326 · SGB-3383-002