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Phase I Trial of Envafolimab for Healthy Male Subjects

NCT05849311 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2024-08-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the pharmacokinetic similarity, safety, and immunogenicity of Envafolimab in healthy male subjects before and after the manufacturing process change.

Conditions

  • Healthy Male

Interventions

DRUG

Envafolimab with new manufacturing process

Dosage form: Envafolimab is a monoclonal antibody drug administered subcutaneously in a minimum packaging unit of 1.0 ml solution in a single-use glass vial containing a total of 200 mg of Envafolimab. Treatment method: Envafolimab, single dose, 1 mg/kg, subcutaneously.

DRUG

Envafolimab with old manufacturing process

Dosage form: Envafolimab is a monoclonal antibody drug administered subcutaneously in a minimum packaging unit of 1.0 ml solution in a single-use glass vial containing a total of 200 mg of Envafolimab. Treatment method: Envafolimab, single dose, 1 mg/kg, subcutaneously.

Sponsors & Collaborators

  • 3D Medicines (Sichuan) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Qing He · Beijing Goboard Boren Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-05-29
Primary Completion
2023-11-15
Completion
2023-11-20

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 NCT05849311 on ClinicalTrials.gov