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Comparative Study of EnliTuo® Before and After Technology Change in Healthy Male Volunteers

NCT07246291 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2026-05-07

No results posted yet for this study

Summary

This study is a randomized, double-Blind, parallel-controlled, single-dose pharmacokinetic, safety, and immunogenicity comparative study of EnliTuo® before and after technology change in healthy male volunteers.

Conditions

  • Healthy Adult Male

Interventions

BIOLOGICAL

New technology Enlituo

250 mg/m\^2, single intravenous drip

BIOLOGICAL

Approved technology Enlituo

250 mg/m\^2, single intravenous drip

Sponsors & Collaborators

  • Taizhou Mabtech Pharmaceutical Co.,Ltd

    lead INDUSTRY

Principal Investigators

  • Jingying Jia, PhD · Shanghai Xuhui Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-11-11
Primary Completion
2026-04-16
Completion
2026-05-13

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 NCT07246291 on ClinicalTrials.gov