Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
37 participants
INTERVENTIONAL
2025-06-30
2027-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SGB-3383
SGB-3383 for sc injection
SGB-3383
SGB-3383 for sc injection, single dose
SGB-3383-Matching placebo
Normal saline (0.9% NaCl) matching volume of SGB-3383 doses will be administered
SGB-3383-Matching placebo
SC injection, single dose
Interventions
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SGB-3383
SGB-3383 for sc injection, single dose
SGB-3383-Matching placebo
SC injection, single dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
Yes
Sponsors
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Suzhou Sanegene Bio Inc.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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SGB-3383-002
Identifier Type: -
Identifier Source: org_study_id
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