NCT05702450

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 22, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2023

Completed
Last Updated

October 15, 2024

Status Verified

January 1, 2023

Enrollment Period

4 months

First QC Date

January 12, 2023

Last Update Submit

October 14, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic: the maximum concentration (Cmax)

    Concentration and exposure

    up to 57 days

Study Arms (2)

Group P1

EXPERIMENTAL

CM310, Subcutaneous

Biological: CM310

Group P2

ACTIVE COMPARATOR

CM310, Subcutaneous, as the parallel control group

Biological: CM310

Interventions

CM310BIOLOGICAL

CM310 Recombinant Humanized Monoclonal Antibody Injection

Group P1Group P2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have the ability to understand the study.
  • Voluntarily participate in the study and sign the ICF.
  • years ≤ age ≤ 65 years, male and female.
  • Willing to take effective contraceptive measures during the study period.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PKUCare Luzhong Hospital

Zibo, China

Location

Study Officials

  • Jie Hou

    Peking University Care Luzhong Hospital

    PRINCIPAL INVESTIGATOR

  • Hong Wang

    Peking University Care Luzhong Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 27, 2023

Study Start

March 22, 2023

Primary Completion

July 26, 2023

Study Completion

July 26, 2023

Last Updated

October 15, 2024

Record last verified: 2023-01

Locations

CN(1)