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New treatment option for Alzheimer s Disease
Official title SAD Study of CGB3002 in Healthy Participants
ClinicalTrials.gov ID: NCT07660341
What this study is testing
What is CGB3002 0.08 mg/kg?
CGB3002 0.08 mg/kg is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for alzheimer s disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized, double-blind, placebo-controlled phase I clinical study to evaluate the safety, tolerability, pharmacokinetics and immunogenicity of single ascending IV doses of CGB3002 in healthy participants. CGB3002 is being developed to treat Alzheimer's Disease.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- Must have signed written informed consent before any study-related activities are carried out and must be able to understand the full nature and...
- 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...
- Males and females of childbearing potential agree to have no plans for childbearing, use reliable contraceptive measures and not to donate sperm or...
You likely can't join if
- A known history of clinically significant drug allergy or atopic allergic disease (asthma, urticaria, eczematous dermatitis) or a known history of...
- Any disease that may affect the safety evaluation of the participants or the in vivo process of the investigational product, including the central...
- Use of prescription drugs within 14 days or five half-lives (whichever is longer) prior study drug administration, unless determined by the...
- 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...
- With a history of drug abuse within 12 months prior to dosing.
- Cannot tolerate punction, have a history of needle fainting or blood fainting.
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.