Multiple Ascending Dose Study of CM338 in Healthy Volunteers
NCT ID: NCT05371379
Last Updated: 2024-10-15
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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COMPLETED
PHASE1
48 participants
INTERVENTIONAL
2022-05-24
2022-11-04
Brief Summary
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Detailed Description
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Forty-eight healthy volunteers will be enrolled and randomized into 4 groups.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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CM338 75 mg, subcutaneous injection
Qquaque week
CM338 Injection
A humanized monoclonal antibody.
CM338 150 mg, subcutaneous injection
Qquaque week
CM338 Injection
A humanized monoclonal antibody.
CM338 300 mg, subcutaneous injection
Qquaque week
CM338 Injection
A humanized monoclonal antibody.
CM338 300 mg, intravenous infusion
Qquaque week
CM338 Injection
A humanized monoclonal antibody.
Placebo
placebo
CM338 Injection
A humanized monoclonal antibody.
Interventions
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CM338 Injection
A humanized monoclonal antibody.
Eligibility Criteria
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Inclusion Criteria
* Medical history, vital signs, physical examination, 12-lead ECG, X-ray, and abdominal color ultrasound results are normal, or abnormal without clinically significance.
* All clinical laboratory examination are normal, or abnormal without clinical significance.
Exclusion Criteria
* Live attenuated vaccine was administered within 30 days prior to administration or planned to vaccinate during the study period.
* Major surgery will be planned during the study period, or major surgery was performed within 4 weeks prior to dosing.
* Any blood loss greater than 400 mL by voluntary blood donation or in any other manner within 4 weeks prior to administration.
18 Years
65 Years
MALE
Yes
Sponsors
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Keymed Biosciences Co.Ltd
INDUSTRY
Responsible Party
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Locations
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PKUCare Luzhong Hospital
Zibo, , China
Countries
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Other Identifiers
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CM338-100002
Identifier Type: -
Identifier Source: org_study_id
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