Study to Evaluate Pharmacokinetics, Safety and Efficacy o... | NCT05702450

Studies
Study to Evaluate Pharmacokinetics, Safety and Efficacy of CM310

NCT05702450

Sponsor

Keymed Biosciences Co.Ltd

Status

Completed

Last Update Posted

Oct 15, 2024Actual

Enrollment

240Actual

Phase

Phase 1

Conditions

Healthy

Interventions

CM310

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 22, 2023Actual

Primary Completion Date

Jul 26, 2023Actual

Completion Date

Jul 26, 2023Actual

First Submitted Date

Jan 12, 2023

First Submission Date that Met QC Criteria

Jan 25, 2023

First Posted Date

Jan 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2024

Last Update Posted Date

Oct 15, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

240Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group P1	Experimental	CM310, Subcutaneous	Biological: CM310
Group P2	Active Comparator	CM310, Subcutaneous, as the parallel control group	Biological: CM310

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CM310	Biological	CM310 Recombinant Humanized Monoclonal Antibody Injection	Group P1 Group P2

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jie Hou	Peking University Care Luzhong Hospital	Principal Investigator
Hong Wang	Peking University Care Luzhong Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PKUCare Luzhong Hospital		Zibo			China