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โ† Trials
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Study of CM383 in Healthy Subjects

RecruitingPhase 1Ages 18 Years - 54 YearsMaleKeymed Biosciences Co.Ltd
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In plain words

What the trial is, and whether it could suit you

This study is a Phase I, single-center, randomized, open-label, parallel-controlled study, aimed at evaluating the pharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability of a single dose of CM383 administered via intravenous infusion or subcutaneous injection in healthy male subjects.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Subjects age โ‰ฅ 18 years \& โ‰ค54 years. * Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol. Exclusion Criteria: * The average number of cigarettes smoked per day is greater than 5 within 3 months prior to screening. * 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 Aฮฒ-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.
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What it tests

  • CM383
  • CM383
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Where

1 site
The Second Affiliated Hospital Zhejiang University School of Medcine
Hangzhou, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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