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You do not need to have the condition being studied to take part.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 55
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
46 (estimated)
Sponsor
ChainGen Biopharma Ltd · Industry
Who this trial is looking for
This trial is looking for healthy adults aged 18 to 55 who want to help test a new treatment for Alzheimer's Disease. Participants will receive an intravenous dose of the treatment and undergo safety assessments.
Are You a Good Fit for This Trial?
You may be able to join if
I am between 18 and 55 years old.
I weigh at least 50 kg if male or at least 40 kg if female.
I agree to use effective contraception if I can become pregnant.
I can provide written consent and understand the trial details.
You may not be able to join if
I have a significant drug allergy or allergic disease.
I cannot tolerate needles or have fainted from them in the past.
I have participated in another clinical trial in the last 30 days.
I have had significant blood loss in the last 30 days.
I took prescription drugs in the last 14 days.
I tested positive for HIV, hepatitis, or syphilis.
I have major brain or blood vessel issues shown in an MRI.
I have a history of drug abuse in the last 12 months.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Status
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 adh…
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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