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
NCT06309043
Phase
Phase 1
Recruitment status
Active, not recruiting
Participants
Lead sponsor
Shanghai Henlius Biotech
Start date
2024-04-22
Number of sites
- 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. This study is divided into two parts.
- Short 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
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2026-12-31
- First posted
- 2024-03-13
- Registry last updated
- 2024-06-17
- Primary completion date
- 2026-06-01
- Start date
- 2024-04-22
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Registry sponsor category
- Industry
- Lead sponsor
- Shanghai Henlius Biotech
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT06309043
- ClinicalTrials.gov ID
- NCT06309043
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Quadruple masking
- Masked roles
- Participants, Care providers, Investigators, Outcome assessors
Sources for study design
AUC0-inf
Timeframe: 0 to Day 29
Area under the serum concentration-time curve from time 0 to infinity
Cmax
Timeframe: 0 to Day 29
Maximum serum concentration
Tmax
Timeframe: 0 to Day 29
Time to reach maximum serum concentration
CL
Timeframe: 0 to Day 29
Total clearance
λz
Timeframe: 0 to Day 29
Apparent terminal elimination rate constant
Sources for outcomes
- Sex
- Male
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 50 Years
- Healthy volunteers
- Yes
- 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; 5. After fully understanding the content of the trial and possible adverse reactions, the subjects who voluntarily participate in the trial, are willing to sign the informed consent form (ICF), and are able to complete the study in accordance with the trial protocol.
- 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;
- 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;
- Those with hereditary bleeding tendency or coagulation disorder, or a history of thrombosis or bleeding disorders;
- With known or suspected history of keratitis, ulcerative keratitis, or severe dry eye disease;
- With a history of surgery within 3 months prior to screening, or planned surgery during the trial;
- Intolerant to venipuncture or with a history of needle or blood phobia;
- With a history of drug abuse within 6 months prior to screening;
- Use of narcotics within 3 months prior to screening;
- Subjects who have donated blood including blood components or lost blood (≥ 200 mL), received blood transfusion, or used blood products within 3 months prior to screening;
- Subjects who have received anti-EGFR targeted drugs (including monoclonal antibodies and TKIs) or other monoclonal antibodies within 3 months prior to screening;
Sources for eligibility
- Affiliated Hospital of Xuzhou Medical UniversityXuzhou, China
Sources for sites