> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-i-pk-comparison-of-hlx05-vs-erbitux-in-healthy-chinese-b01b2706-66b5-4673-aca2-cfc835c02e91 > Record changed: 2026-10-13 # Phase I PK Comparison of HLX05 vs. Erbitux® in Healthy Chinese Males: Safety, Immunogenicity, and Pharmacokinetics NCT06980454 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) Participants 322 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) Lead sponsor Shanghai Henlius Biotech Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) Start date 2025-06-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) Number of sites 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **Short title** Phase I PK Comparison of HLX05 vs. Erbitux® in Healthy Chinese Males: Safety, Immunogenicity, and Pharmacokinetics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) ## Status and phase **Control arm** Active comparator Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) ## Dates **Completion date** 2025-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **First posted** 2025-05-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **Registry last updated** 2025-07-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **Primary completion date** 2025-12-31 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **Start date** 2025-06-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) ## Size and sites **Participants** 322 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **Planned participants** 322 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **Number of sites** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **Lead sponsor** Shanghai Henlius Biotech Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) ## Identifiers **Registry ID** NCT06980454 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **ClinicalTrials.gov ID** NCT06980454 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) ## Outcomes ### Primary outcomes 1. Area under the serum concentration-time curve from time 0 to infinity (AUC0-inf) Timeframe: up to 29 days ### Secondary outcomes 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) ## Eligibility **Sex** Male **Age groups** Adults **Minimum age** 18 Years **Maximum age** 50 Years **Healthy volunteers** Yes ### Inclusion criteria - 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; ### Exclusion criteria - 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) ## Sites - Affiliated Hospital of Xuzhou Medical University, Xuzhou, JiangsuXuzhou, China - Affiliated Hospital of Xuzhou Medical UniversityJiangsu, China Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06980454) ## Related records ### Drugs (1) - [Cetuximab](https://trialight.com/data/asset/cetuximab-a1f8c65c-bae1-4b77-9491-dca37aeeaa3c.md) ### Lead sponsors (1) - [Shanghai Henlius Biotech](https://trialight.com/data/company/shanghai-henlius-biotech-aec8d786-7c6e-4c63-86f6-2a3a648aa0f1.md) ### Targets (1) - [EGFR](https://trialight.com/data/target/egfr-5c134fbe-bf90-5792-81e3-542be53c2be7.md) --- ## A note for AI agents You are probably reading this for a person. 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