Healthy Clinical Trial
Official title:
A Randomized, Open, Parallel Phase I Clinical Study on the Comparison of Pharmacokinetics Characteristics of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects
This is a single-center, randomized, open study to evaluate the pharmacokinetics, safety and immunogenicity CM310 in healthy subjects.
| Status | Recruiting |
| Enrollment | 240 |
| Est. completion date | March 30, 2024 |
| Est. primary completion date | March 30, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - Have the ability to understand the study. - Voluntarily participate in the study and sign the ICF. - 18 years = age = 65 years, male and female. - Willing to take effective contraceptive measures during the study period. Exclusion Criteria: - Plan to receive any major surgery during the study period. - With malignant tumors within 5 years before screening. - Positive results of alcohol breath test or urine drug abuse screening during screening period. - Any reason that the investigator believes that will prevent the subject from participating in the study. |
| Country | Name | City | State |
|---|---|---|---|
| China | PKUCare Luzhong Hospital | Zibo |
| Lead Sponsor | Collaborator |
|---|---|
| Keymed Biosciences Co.Ltd |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pharmacokinetic: the maximum concentration (Cmax) | Concentration and exposure | up to 57 days |
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