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CompletedNCT05715333Updated Nov 8, 2024

Study of CM326 Injection in Healthy Subjects

A Phase 1 interventional study of CM326 and Placebo in Healthy, sponsored by Keymed Biosciences Co.Ltd. Completed at 1 site in China. Open to male participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-08.

Sponsored by Keymed Biosciences Co.Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
46
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Male
01

Study summary

This study is a single-center, randomized, double-blind, placebo-controlled, dose-increasing phase I clinical study.

Read the detailed description

The purpose of this study is to evaluate the safety, tolerance, pharmacokinetics and immunogenicity of single and multiple subcutaneous administration of CM326 at different doses in healthy male subjects.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Keymed Biosciences Co.Ltd is the lead sponsor of 66 studies on the registry; 32 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥18 years and ≤ 65 years, healthy male.
  • With normal or abnormal laboratory test results without clinical significanceat screening period and baseline.
  • Subjects can communicate well with investigators and comply with protocol requirements.

Exclusion criteria

Exclusion Criteria:

  • Any live attenuated vaccine is planned to be inoculated 30 days before administration or during the study period.
  • Major surgery is planned during the study period.
  • The average daily smoking volume is more than 5 cigarettes within 3 months before screening.
  • Within 12 weeks before administration, blood loss from voluntary blood donation or any attempt to visit is greater than 400 mL.
  • There are any reasons that the investigator believes will prevent the subject from participating in the study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
46 participants (actual)

Study arms

  • Experimental
    Group 1

    CM326 220 mg/2 mL or matched placebo, subcutaneous at low dose

    Biological: CM326 · Other: Placebo

  • Experimental
    Group 2

    CM326 220mg/2 mL or matched placebo, subcutaneous at medium dose

    Biological: CM326 · Other: Placebo

  • Experimental
    Group 3

    CM326 220mg/2mL or matched placebo, subcutaneous at high dose

    Biological: CM326 · Other: Placebo

  • Experimental
    Group 4

    CM326 220mg/2mL or matched placebo, subcutaneous at medium dose

    Biological: CM326 · Other: Placebo

Interventions

  • BiologicalCM326

    CM326 Injection

  • OtherPlacebo

    Subcutaneous injection

06

What researchers measure

Primary outcomes

  1. Emergency adverse events during treatment

    By assessing the number and severity of adverse events during the study.

    Time frame: Up to week 12

07

Study locations

1 site
  • PKUCare Luzhong Hospital
    Zibo, China
08

References and documents

Publications

  • Di Y, Yang L, Zhou J, Zhang L, Huang Y, Jia Y, Yan H, Chen L, Hou Q, Chen B, Luo Z, Hou J. Translational Investigation of CM326 from Preclinical Studies to Randomized Phase I Clinical Trials in Healthy Adults. BioDrugs. 2025 May;39(3):487-498. doi: 10.1007/s40259-025-00714-4. Epub 2025 Apr 4. PubMed 40185989 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05715333
Lead sponsor
Keymed Biosciences Co.Ltd
Responsible party
Sponsor
First posted
Feb 8, 2023
Start date
Mar 21, 2023
Primary completion
Oct 4, 2023
Completion
Oct 4, 2023
Last update
Nov 8, 2024

Study contacts

Jie Hou
principal investigator · Peking University Care Luzhong Hospital
Hong Wang
principal investigator · Peking University Care Luzhong Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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