Phase I PK Comparison of HLX05 vs. Erbitux® in Healthy Chinese Males: Safety, Immunogenicity, and Pharmacokinetics

NCT06980454
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Phase
Phase 1
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Recruitment status
Active, not recruiting
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Participants
322
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Lead sponsor
Shanghai Henlius Biotech
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Start date
2025-06-04
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Number of sites
2
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Summary
This is a randomized, single intravenous dose, parallel study to compare the PK characteristics, safety, tolerability, and immunogenicity of HLX05 vs. Erbitux® (US-, EU-, and CN-sourced) in healthy adult male Chinese subjects.
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Short title
Phase I PK Comparison of HLX05 vs. Erbitux® in Healthy Chinese Males: Safety, Immunogenicity, and Pharmacokinetics
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Official title
A Randomized, Single Intravenous Dose, Parallel Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX05 Vs. Erbitux® (Cetuximab) in Healthy Adult Male Chinese Subjects
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2025-12-31
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First posted
2025-05-20
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Registry last updated
2025-07-08
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Primary completion date
2025-12-31
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Start date
2025-06-04
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Participants
322
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Participant count basis
Estimated
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Planned participants
322
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Protocol amendments
0
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Number of sites
2
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Shanghai Henlius Biotech
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06980454
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ClinicalTrials.gov ID
NCT06980454
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Quadruple masking
Masked roles
Participants, Care providers, Investigators, Outcome assessors
Sources for study design
clinicaltrials.gov

  1. Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf)

    Timeframe: up to 29 days

  1. Cmax

    Timeframe: up to 29 days

    Maximum serum concentration

  2. Tmax

    Timeframe: up to 29 days

    Time to reach maximum serum concentration

  3. CL

    Timeframe: up to 29 days

    Total clearance

  4. λz

    Timeframe: up to 29 days

    Apparent terminal elimination rate constant

Sources for outcomes
clinicaltrials.gov

Sex
Male
Age groups
Adults
Minimum age
18 Years
Maximum age
50 Years
Healthy volunteers
Yes

  • Subjects who meet all the following criteria are allowed to be enrolled:

    1. Males aged 18-50 years (inclusive);
    2. Body mass index (BMI) = body weight (kg)/height2 (m2); BMI between 18.5 and 28.0 (inclusive), and body weight of male subjects ≥ 50 kg;
    3. Subjects without abnormalities or those with abnormalities with no clinical significance in terms of vital signs measurement, physical examination, clinical laboratory tests (hematology, urinalysis, serum chemistry, infectious disease indicators, coagulation function, cardiac markers, alcohol screening, drug screening, etc.), 12-lead ECG examination, chest X-ray, and abdominal B ultrasound;
    4. Subjects who voluntarily take effective contraceptive measures and have no sperm donation plan during the screening period and within 3 months after drug administration, and voluntarily take non-drug contraceptive measures during the trial;

  • 1. With allergic constitution, or history of food or drug allergy; known history of allergy to any ingredient of the study drug or excipients or monoclonal antibody agents; history of infusion reactions; 2. Subjects with a history of seborrheic dermatitis or other types of dermatitis, rashes, etc., in the past or currently; 3. Subjects with a history of cardiovascular, respiratory, endocrine, hepatic, renal, gastrointestinal, nervous system, or hematological, immunological, psychiatric, metabolic obvious abnormalities, skin diseases, or other significant diseases, and are judged by the investigator as unsuitable for participating in the trial; 4. Those with hereditary bleeding tendency or coagulation disorder, or a history of thrombosis or bleeding disorders; 5. With known or suspected history of keratitis, ulcerative keratitis, or severe dry eye disease;
Sources for eligibility
clinicaltrials.gov

  • Affiliated Hospital of Xuzhou Medical University, Xuzhou, JiangsuXuzhou, China
  • Affiliated Hospital of Xuzhou Medical UniversityJiangsu, China
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Targets (1)