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OpenTrials
Completed

NCT Number: NCT05702450

Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310

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

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PKUCare Luzhong Hospital

Zibo, China

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CM310

Biological

CM310 Recombinant Humanized Monoclonal Antibody Injection

Primary outcomes

  1. Pharmacokinetic: the maximum concentration (Cmax)

    Time frame: up to 57 days

    Concentration and exposure

Sponsors and collaborators

Lead sponsor

Keymed Biosciences Co.Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 27, 2023
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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