RecruitingPhase 1NCT07813468

A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects

A Phase I, Randomized, Double-Blind, Positive-Controlled, Parallel-Group Pharmacokinetic Clinical Study of Cetuximab Injection Versus Erbitux in Healthy Male Subjects

Sponsor

HC Biopharma Inc.

Enrollment

92 participants

Start Date

Sep 5, 2026

Study Type

INTERVENTIONAL

Conditions

Bioequivalence Healthy Volunteers Cetuximab Pharmacokinetics

Summary

A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection versus Erbitux in Healthy Male Subjects

Eligibility

Sex: MALEMin Age: 18 YearsMax Age: 46 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Erbitux (Cetuximab) and a drug called HC034S for people with bioequivalence, cetuximab, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include men aged 18 Years to 46 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGHC034S

Single intravenous infusion. Study participants shall be pre-medicated with antihistamines and corticosteroids no less than 1 h before the first HC034S injection infusion. Administer intravenously by infusion pump at 250 mg/m² (body surface area), infusion duration: 2 h ± 10 min.

DRUGErbitux (Cetuximab)

Single intravenous infusion. Study participants shall be pre-medicated with antihistamines and corticosteroids no less than 1 h before the first cetuximab injection infusion. Administer intravenously by infusion pump at 250 mg/m² (body surface area), infusion duration: 2 h ± 10 min.