Bioequivalence, Cetuximab, Healthy Volunteers, Pharmacokinetics
Conditions
Brief summary
A Randomized, Double-Blind, Positive-Controlled, Parallel Pharmacokinetic Phase I Clinical Study of Cetuximab Injection versus Erbitux in Healthy Male Subjects
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.
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.
Sponsors
HC Biopharma Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 46 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provide written informed consent prior to study entry and fully understand the study content, procedures and potential adverse reactions; 2. Be able to complete the study as required by the study protocol; 3. Have no fertility plan (including sperm donation) in the subsequent 6 months and agree to use effective contraception; 4. 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).
Exclusion criteria
1. Provide written informed consent prior to study entry and fully understand the study content, procedures and potential adverse reactions; 2. Be able to complete the study as required by the study protocol; 3. Have no fertility plan (including sperm donation) in the subsequent 6 months and agree to use effective contraception; 4. 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the serum concentration-time curve from time 0 to infinity (AUC0-∞) | Up to Day 29 |
Secondary
| Measure | Time frame |
|---|---|
| quantifiable concentration (AUC₀-t) | Up to Day 29 |
| Maximum serum concentration (Cmax) | Up to Day 29 |
| Time to reach maximum serum concentration (Tmax) | Up to Day 29 |
| Total clearance (CL) | Up to Day 29 |
| Terminal elimination half-life (t1/2) | Up to Day 29 |
| Apparent volume of distribution (Vd) | Up to Day 29 |
| Apparent terminal elimination rate constant (λz) | Up to Day 29 |
| Percentage of the area-under-the-curve extrapolated to infinity (AUC_%Extrap) | Up to Day 29 |
| Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) following study drug administration, including electrocardiograms (ECG), laboratory test parameters, physical examinations, and vital signs. | Up to Day 29 |
| Positive incidence, titer and duration of anti-drug antibodies (ADA) and neutralizing antibodies (NAb) | Up to Day 29 |
Countries
China
Contacts
CONTACTXiaoai He
Outcome results
None listed