NCT05702450
Completed
Phase 1
A Randomized, Open, Parallel Phase I Clinical Study on the Comparison of Pharmacokinetics Characteristics of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects
Keymed Biosciences Co.Ltd1 site in 1 country240 target enrollmentMarch 22, 2023
Overview
- Phase
- Phase 1
- Intervention
- CM310
- Conditions
- Healthy
- Sponsor
- Keymed Biosciences Co.Ltd
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- Pharmacokinetic: the maximum concentration (Cmax)
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a single-center, randomized, open study to evaluate the pharmacokinetics, safety and immunogenicity CM310 in healthy subjects.
Detailed Description
This study includes screening and treatment and follow-up periods.
Investigators
Eligibility Criteria
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.
Arms & Interventions
Group P1
CM310, Subcutaneous
Intervention: CM310
Group P2
CM310, Subcutaneous, as the parallel control group
Intervention: CM310
Outcomes
Primary Outcomes
Pharmacokinetic: the maximum concentration (Cmax)
Time Frame: up to 57 days
Concentration and exposure
Study Sites (1)
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