Study Evaluating the Pharmacokinetics of CM310 in Healthy... | NCT06171048

Studies
Study Evaluating the Pharmacokinetics of CM310 in Healthy Subjects

NCT06171048

Sponsor

Keymed Biosciences Co.Ltd

Status

Unknown status

Last Update Posted

Dec 14, 2023Actual

Enrollment

236Estimated

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

Dec 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2024Estimated

Primary Completion Date

Apr 30, 2025Estimated

Completion Date

Apr 30, 2025Estimated

First Submitted Date

Dec 5, 2023

First Submission Date that Met QC Criteria

Dec 6, 2023

First Posted Date

Dec 14, 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

Dec 6, 2023

Last Update Posted Date

Dec 14, 2023Actual

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-label study to evaluate the pharmacokinetics of 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

236Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	CM310 injection, Subcutaneous	Biological: CM310
Group B	Experimental	CM310 injection, Subcutaneous	Biological: CM310

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CM310	Biological	CM310 injection	Group A Group B

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic: the maximum concentration (Cmax)	Concentration and exposure	up to week 6

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

20 years ≤ age ≤ 45 years.
Voluntarily participate in the study and sign the ICF.
Have the ability to understand the study.

Exclusion Criteria:

With history of chronic or serious illness.
With any medication within 28 days prior to administration;
Plan to undergo surgery during the research period;
With any situations unsuitable to participate in this study.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Qian Jia	Contact	028-88610620		qianjia@keymedbio.com

Overall Officials

Name	Affiliation	Role
Wei Hu	The Second Hospital of Anhui Medical University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Hospital of Anhui Medical University		Hefei	Anhui		China