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RecruitingNCT06285227Updated Oct 16, 2024

Study of CM313 in Healthy Subjects

A Phase 1 interventional study of CM313 injection in Healthy, sponsored by Keymed Biosciences Co.Ltd. Recruiting at 1 site in China. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-16.

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

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started Mar 2024; still recruiting 2 years 6 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

This study is a single center, randomized, open/double-blind, placebo-controlled, single dose, dose escalation Phase I clinical study aimed at evaluating the safety, tolerability, pharmacokinetics, pharmacokinetic characteristics, and immunogenicity of CM313 administered subcutaneously or intravenously 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 63 studies on the registry; 31 are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Subjects age ≥ 18 years \& ≤50 years.
  • Subjects voluntarily signed the Informed Consent Form and were able to comply with the provisions of this protocol.

Exclusion criteria

Exclusion Criteria:

  • With history of malignant tumors;
  • Plan to undergo major surgery during the research period
  • Known to be allergic to monoclonal antibody drugs or other related drugs, food, or CM313 excipients;
  • With any voluntary blood donation or any other form of blood loss exceeding 400 mL;
  • The average daily smoking volume within the first three months of screening is greater than 5 cigarettes;
  • Positive results in baseline alcohol breath test or urine drug abuse screening.
05

Study design

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

Study arms

  • Experimental
    Group 1

    CM313, subcutaneous injection, once

    Biological: CM313 injection

  • Experimental
    Group 2

    CM313, subcutaneous injection, once

    Biological: CM313 injection

  • Experimental
    Group 3

    CM313, subcutaneous injection, once

    Biological: CM313 injection

  • Experimental
    Group 4

    CM313, infusion, once

    Biological: CM313 injection

Interventions

  • BiologicalCM313 injection

    CM313

06

What researchers measure

Primary outcomes

  1. Adverse event

    Incidence, severity, and outcome of treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Time frame: Up to week 12

07

Study locations

1 of 1 sites recruiting
  • Huashan Hospital Fudan University
    Shanghai, China
    • Qing Zhang · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06285227
Lead sponsor
Keymed Biosciences Co.Ltd
Responsible party
Sponsor
First posted
Feb 29, 2024
Start date
Mar 12, 2024
Primary completion
Apr 30, 2025 (estimated)
Completion
Apr 30, 2025 (estimated)
Last update
Oct 16, 2024

Study contacts

Qian Jia
Contact
qianjia@keymedbio.com
028-88610620
Qing Zhang
principal investigator · Huashan Hospital
Yu Xue
principal investigator · Huashan Hospital

Oversight

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

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