Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2025-12-31
2026-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CM383 subcutaneous injection group 1
CM383
CM383 subcutaneous injection, once.
CM383 subcutaneous injection group 2
CM383
CM383 subcutaneous injection, once.
CM383 intravenous infusion group
CM383
CM383 intravenous infusion, once.
Interventions
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CM383
CM383 subcutaneous injection, once.
CM383
CM383 intravenous infusion, once.
Eligibility Criteria
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Inclusion Criteria
* Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.
Exclusion Criteria
* Drinking heavily within 3 months prior to screening, or unable to guarantee not to drink alcohol during the research period, or positive alcohol breath testing.
* History of drug abuse within 1 year prior to screening, or positive urine drug abuse screening.
* Blood donation or any other form of blood loss exceeding 400 mL, or accepting blood transfusion within 12 weeks prior to screening.
* Suspected allergy to Aβ-antibody drugs, humanized monoclonal antibody drugs and their excipients, or other biological agents, or have a history of severe allergic reactions to other drugs.
* Severe trauma or undergo major surgery within 6 months prior to screening, or planned surgery during the research period.
18 Years
54 Years
MALE
Yes
Sponsors
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Keymed Biosciences Co.Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Bo Jiang
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital Zhejiang University School of Medcine
Locations
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The Second Affiliated Hospital Zhejiang University School of Medcine
Hangzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Bo Jiang
Role: primary
Other Identifiers
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CM383-100002
Identifier Type: -
Identifier Source: org_study_id