Healthy VolunteersPhase 1NCT06995326
A Study of SGB-3383 in Healthy Subjects
A Phase 1 study testing SGB-3383 in people with Healthy Volunteers, run by Suzhou Sanegene Bio Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- SGB-3383
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Jun 2025to Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
- Conditions
- Healthy Volunteers
- Being tested
- SGB-3383, SGB-3383-Matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGB-3383Drug
SGB-3383 for sc injection, single dose
SGB-3383-Matching placeboDrug
SC injection, single dose
| Study group | Role | What they receive |
|---|---|---|
| SGB-3383 | Experimental | SGB-3383 for sc injection Receives: Drug: SGB-3383 |
| SGB-3383-Matching placebo | Placebo comparator | Normal saline (0.9% NaCl) matching volume of SGB-3383 doses will be administered Receives: Drug: SGB-3383-Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events (AEs)
Measured: up to approximately 12 months
Secondary outcomes (2)
Maximum Observed Plasma Concentration (Cmax) of SGB-3383
Measured: Up to Day 3
Area Under the Concentration-time Curve (AUC) of SGB-3383
Measured: Up to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study startJun 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suzhou Sanegene Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995326
- Sponsor's protocol ID
- SGB-3383-002
- Status last verified
- May 2025
- First submitted
- 20 May 2025
- Last updated
- 3 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06995326
- Acronym / sponsor ID
- SGB-3383-002
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- Suzhou Sanegene Bio Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SGB-3383 | Experimental | Drug: SGB-3383SGB-3383 for sc injection |
| SGB-3383-Matching placebo | Placebo comparator | Drug: SGB-3383-Matching placeboNormal saline (0.9% NaCl) matching volume of SGB-3383 doses will be administered |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGB-3383SGB-3383 for sc injection, single dose | Drug | SGB-3383 |
| SGB-3383-Matching placeboSC injection, single dose | Drug | SGB-3383-Matching placebo |
Primary outcome
Number of Participants with Adverse Events (AEs)
Time frame: up to approximately 12 months
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2025.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SGB-3383 in people with Healthy Volunteers, run by Suzhou Sanegene Bio Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SGB.clinical (+086 021-60209828, SGB.clinical@sanegenebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events (AEs) (time frame: up to approximately 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2025.