Healthy Clinical Trial
Official title:
A Pharmacokinetics Study of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects
This is a single-center, randomized, open-label study to evaluate the pharmacokinetics of CM310 in healthy subjects.
| Status | Not yet recruiting |
| Enrollment | 236 |
| Est. completion date | April 30, 2025 |
| Est. primary completion date | April 30, 2025 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Male |
| Age group | 20 Years to 45 Years |
| Eligibility | Inclusion Criteria: - 20 years = age = 45 years. - Voluntarily participate in the study and sign the ICF. - Have the ability to understand the study. Exclusion Criteria: - With history of chronic or serious illness. - With any medication within 28 days prior to administration; - Plan to undergo surgery during the research period; - With any situations unsuitable to participate in this study. |
| Country | Name | City | State |
|---|---|---|---|
| China | The Second Hospital of Anhui Medical University | Hefei | Anhui |
| 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 week 6 |
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