Can a new injection SGB-9768 pass its first safety test?
NCT ID NCT06501573
First seen Sep 04, 2026 ยท Last updated Sep 04, 2026
Summary
Researchers are testing an investigational drug called SGB-9768 in healthy adults aged 18 to 55. The trial gives a single injection under the skin and checks how the body handles the drug and whether it causes side effects. Participants are randomly assigned to receive either SGB-9768 or a placebo, and neither they nor the researchers know which they get. This early study focuses on safety and tolerability, not on treating any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- SGB-9768, an investigational drug given as an injection under the skin
- What this could lead to
- If SGB-9768 proves safe and well tolerated, it could advance to larger studies for conditions it may target, though this trial does not test its effectiveness.
- What could go wrong
- This is an early phase 1 trial in a small group of healthy volunteers, so it focuses on safety, not benefit. The drug may cause side effects or fail in later trials.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
45 people
The number who actually took part.
- Started
-
Jul 2024
- Finished
-
May 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 55 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Male and female subjects aged 18 to 55 years are included at the time of informed consent. * Body mass index between 18 and 28 kg/m2 at screening, inclusive, at screening a weight of at least 45 kg for female and 50 kg for male. * Physical examination, vital signs, 12-lead electrocardiogram, and laboratory tests be normal or slightly abnormal but not clinically significant according to investigator's judgement. * Women of child-bearing potential who are not exclusively in same-sex relationships and males with partners of child-bearing potential must agree to use adequate contraception from signing the informed consent until 12 weeks 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 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 or evidence of tuberculosis. * History of recurrent or chronic infections. * Subjects with a history of meningococcal infection, or subjects who are exposed to Neisseria meningitidis. * History of asplenia or splenectomy. * History of abnormalities in complement or hereditary complement deficiency. * Received an investigational agent within 30 days or 5-half-lives (whichever is longer) before the first dose of the study drug or being in other clinical study. * History or clinical evidence of drug abuse within 12 months before screening or positive screen for drugs of abuse. * Used prescribed or over-the-counter medication within 14 days or 5 half-lives (whichever is longer) before the first dose of the study drug unless determined not clinically relevant by the Investigator. * Any conditions which, in the opinion of the Investigator, would make the subject unsuitable for enrollment or could interfere with the subject's participation in or completion of the study.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Huashan hospital
Shanghai, China
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