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Study of CM313 in Healthy Subjects

NCT06285227 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2024-10-16

No results posted yet for this 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.

Conditions

  • Healthy

Interventions

BIOLOGICAL

CM313 injection

CM313

Sponsors & Collaborators

  • Keymed Biosciences Co.Ltd

    lead INDUSTRY

Principal Investigators

  • Qing Zhang · Huashan Hospital

  • Yu Xue · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-12
Primary Completion
2025-04-30
Completion
2025-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06285227 on ClinicalTrials.gov