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NCT05702450 | Recruiting | Healthy

Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310
Sponsor:

Keymed Biosciences Co.Ltd

Brief Summary:

This is a single-center, randomized, open study to evaluate the pharmacokinetics, safety and immunogenicity CM310 in healthy subjects.

Condition or disease

Healthy

Intervention/treatment

CM310

Phase

Phase 1

Detailed Description:

This study includes screening and treatment and follow-up periods.}}

Study Type : Interventional
Estimated Enrollment : 240 participants
Masking : None (Open Label)
Primary Purpose : Treatment
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
Actual Study Start Date : March 22, 2023
Estimated Primary Completion Date : March 30, 2024
Estimated Study Completion Date : March 30, 2024
Arm Intervention/treatment

Experimental: Group P1

CM310, Subcutaneous

Biological: CM310

Active Comparator: Group P2

CM310, Subcutaneous, as the parallel control group

Biological: CM310
Ages Eligible for Study: 18 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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.
Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310

Location Details

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Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

China,

PKUCare Luzhong Hospital

Zibo, China,