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Recruiting
NCT07660341
SAD Study of CGB3002 in Healthy Participants
Conditions: Alzheimer s Disease
Sex: All
Ages: 18 Years – 55 Years
Healthy volunteers: Yes
Phase: PHASE1
Enrollment: 46
Sponsor: ChainGen Biopharma Ltd
Location: Nucleus Network Melbourne Victoria
Summary
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.
Eligibility Criteria
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\ 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.
Source: ClinicalTrials.gov (NCT07660341). StuddyBuddy aggregates publicly available trial information.