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

ConditionsCetuximabBioequivalenceHealthy VolunteersPharmacokinetics
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age18-46
SponsorHC Biopharma Inc.

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Provide written informed consent prior to study entry and fully understand the study content, procedures and potential adverse reactions;

Be able to complete the study as required by the study protocol;

Have no fertility plan (including sperm donation) in the subsequent 6 months and agree to use effective contraception;

Be healthy male subjects aged 18-46 years (inclusive); body weight ≥50 kg; body mass index (BMI, calculated as weight [kg]/height² [m²]) ranging from 18.0 to 28.5 kg/m² (inclusive).

Disqualifiers

Provide written informed consent prior to study entry and fully understand the study content, procedures and potential adverse reactions;

Be able to complete the study as required by the study protocol;

Have no fertility plan (including sperm donation) in the subsequent 6 months and agree to use effective contraception;

Be healthy male subjects aged 18-46 years (inclusive); body weight ≥50 kg; body mass index (BMI, calculated as weight [kg]/height² [m²]) ranging from 18.0 to 28.5 kg/m² (inclusive).

Trial design

Design model

Parallel

Treatments tested in this trial

  • HC034S

    Drug

    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.

  • Erbitux (Cetuximab)

    Drug

    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.

Treatment groups

92 Participants
are divided into 2 treatment groups
Group A: HC034SExperimental treatment 1 intervention
Group B: China-sourced Erbitux®Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Area under the serum concentration-time curve from time 0 to infinity (AUC0-∞)

Time frame
Up to Day 29

Secondary outcomes

1

quantifiable concentration (AUC₀-t)

Time frame
Up to Day 29
2

Maximum serum concentration (Cmax)

Time frame
Up to Day 29
3

Time to reach maximum serum concentration (Tmax)

Time frame
Up to Day 29
4

Total clearance (CL)

Time frame
Up to Day 29

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HC Biopharma Inc.

Lead sponsor

Source ClinicalTrials.gov
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