New Alzheimer's drug candidate takes first step in human safety trial
NCT ID NCT07660341
First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times
Summary
This study tests a single intravenous dose of an experimental drug called CGB3002 in healthy adults aged 18 to 55. The main goal is to see if the drug is safe and how the body processes it. This is a first step toward possibly developing a treatment for Alzheimer's disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CGB3002
- What this could lead to
- If safe, this could open the door to testing CGB3002 as a potential treatment for Alzheimer's disease.
- What could go wrong
- This is a very early, small study in healthy people, not those with Alzheimer's. It only checks safety and how the drug moves through the body, not whether it works against the disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 46 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2026
- Expected to finish
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Apr 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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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: * Must have signed written informed consent before any study-related activities are carried out and must be able to understand the full nature and purpose of the trial, including possible risks and adverse effects. Be willing and able to comply with all study assessments and adhere to the protocol schedule and restrictions. * Age≥18 years and\<55 years at the time of consent, healthy participants, male or female. * A body mass index (BMI) of 18 to 32 kg/m2 (cutoff inclusive), with male participants weighing no less than 50 kg, female participants weighing no less than 40 kg. * Males and females of childbearing potential agree to have no plans for childbearing, use reliable contraceptive measures and not to donate sperm or ova from 30 days prior to dosing until 120 days after dosing. For females of childbearing potential, hormonal contraceptives should begin at least 1 month prior to screening to ensure contraceptive is in full effect. Exclusion Criteria: * A known history of clinically significant drug allergy or atopic allergic disease (asthma, urticaria, eczematous dermatitis) or a known history of allergy to biologics or any excipients in biologics, fully resolved childhood asthma can be enrolled. * Any disease that may affect the safety evaluation of the participants or the in vivo process of the investigational product, including the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, hematopoietic system, metabolic endocrine system, etc. * Use of prescription drugs within 14 days or five half-lives (whichever is longer) prior study drug administration, unless determined by the Investigator and Sponsor to be non-interfering (e.g., hormonal contraceptives). * Use of over-the-counter (OTC) or Chinese herbal medicine within 7 days or 5 half-lives (whichever is longer) prior to study drug administration, unless determined by the Investigator and Sponsor to be non-interfering. * With a history of drug abuse within 12 months prior to dosing. * Cannot tolerate punction, have a history of needle fainting or blood fainting. * Have participated in clinical trials, whether for drugs or medical devices, within 30 days prior to administration or within 7 times the known elimination half-life, whichever is longer. * Blood donation or significant blood loss (\> 300 mL) within 30 days prior to dosing, and planning to blood donate during the study. * Any vaccinations with a live vaccine (excluding influenza vaccine) within 60 days prior to dosing. * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥1.5×ULN at screening or Day -2. Total bilirubin (TBIL) \> ULN at screening or Day -2(except in those due to findings consistent with Gilbert's disease). * Estimated creatinine clearance \< 80 mL/ min (Cockroft-Gault equation) at screening or Day-2. * Test positive for syphilis, hepatitis B virus surface antigen (HbsAg), hepatitis B core antibody (HBcAb), hepatitis C virus antibody (HCV-Ab) or HIV antibody at screening. * Urine drug screening positive at screening or Day-2. * Have a head MRI demonstrating either cerebral microhemorrhages, or superficial siderosis, or prior evidence of microhemorrhage, or any other major intracranial pathology. * Still needed or planned to engage in vigorous physical activity or exercise during study participation. * Other conditions deemed inappropriate by the investigator to participate in the clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Nucleus Network
RECRUITINGMelbourne, Victoria, 3004, Australia
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