NCT06171048

Brief Summary

This is a single-center, randomized, open-label study to evaluate the pharmacokinetics of CM310 in healthy subjects.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
236

participants targeted

Target at P75+ for phase_1 healthy

Timeline
Completed

Started Apr 2024

Longer than P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
unknown

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

December 5, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 14, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

April 30, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

December 14, 2023

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

December 5, 2023

Last Update Submit

December 6, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Pharmacokinetic: the maximum concentration (Cmax)

    Concentration and exposure

    up to week 6

Study Arms (2)

Group A

EXPERIMENTAL

CM310 injection, Subcutaneous

Biological: CM310

Group B

EXPERIMENTAL

CM310 injection, Subcutaneous

Biological: CM310

Interventions

CM310BIOLOGICAL

CM310 injection

Group AGroup B

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Study Officials

  • Wei Hu

    The Second Hospital of Anhui Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Qian Jia

CONTACT

028-88610620qianjia@keymedbio.com

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

December 5, 2023

First Posted

December 14, 2023

Study Start

April 30, 2024

Primary Completion

April 30, 2025

Study Completion

April 30, 2025

Last Updated

December 14, 2023

Record last verified: 2023-12

Locations

CN(1)