Health TrialsbyHealthPanel

A Study of SGB-3383 in Healthy Subjects

ConditionHealthy Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorSuzhou Sanegene Bio Inc.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • SGB-3383

    Drug

    SGB-3383 for sc injection, single dose

  • SGB-3383-Matching placebo

    Drug

    SC injection, single dose

Treatment groups

37 Participants
are divided into 2 treatment groups
Group A: SGB-3383Experimental treatment 1 intervention
Group B: SGB-3383-Matching placeboPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Suzhou Sanegene Bio Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: