Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310

A Randomized, Open, Parallel Phase I Clinical Study on the Comparison of Pharmacokinetics Characteristics of CM310 Recombinant Humanized Monoclonal Antibody Injection in Healthy Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05702450

Enrollment

240

Registered

2023-01-27

Start date

2023-03-22

Completion date

2023-07-26

Last updated

2024-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

BIOLOGICALCM310

CM310 Recombinant Humanized Monoclonal Antibody Injection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetic: the maximum concentration (Cmax)	up to 57 days	Concentration and exposure

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026