Status:
COMPLETED
Phase I Study of HLX3 vs Adalimumab in Chinese Healthy Subjects
Lead Sponsor:
Shanghai Henlius Biotech
Conditions:
Immune System Disorder
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief Summary
This healthy male volunteers study will evaluate 148 subjects who will receive a single sub-cutaneous dose of HLX03 （a monoclonal antibody against TNF-a, 40 mg/ 0.8 mL） or Adalimumab(Humira,China spou...
Detailed Description
This is a randomized, doubl-blinded, parellel-controlled phase 1 PK, safety, tolerability and immunogenicitiy study to compare HLX03, designed as an Adalimumab biosimilar, with China sourced Humira in...
Eligibility Criteria
Inclusion
- Healthy Chinese males (age: 18\~45 yrs) with contraception during and 3 months post-dose. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure, pulse, ECG, and laboratory testing.
- BMI between 19.0 and 28.0 kg/m² and body weight between 55 kg and 80 kg.
Exclusion
- suffering from active or latent tuberculosis or history of tuberculosis;
- have heart disease or a history of heart disease;
- suffer from mental illness or psychiatric history;
- suffering from malignant tumors and their history;
- suffering from herpes zoster and its history;
- suffering from epilepsy and history of epilepsy;
- be allergic to the drugs or its components with high sensitivity or allergic reaction, detection of ADA (+);
- patients who lost blood or donated more than 200 mL within the first 2 months before the screening;
- major surgery performed within 30 days prior to signing ICF;
- live vaccine inoculation or vaccination within 12 weeks of screening, or possible administration of vaccine during screening and study visits;
- previous application of adalimumab or its biosimilars, or anti-TNF alpha drugs;
- participating in other clinical trials within the first 3 months of the trial;
- abnormal immune function within 4 weeks before screening;
- the presence of invasive systemic fungal infection or other opportunistic infections within 2 months prior to screening;
- systemic or local infection, such as the risk of sepsis and / or known active inflammation within 2 months before screening;
- 2 months before the screening, there were severe infections in the hospital and / or the need for intravenous antibiotics;
- 4 or more upper respiratory tract infections occurred within 6 months prior to randomization;
- hepatitis B surface antigen (HBsAg) positive; if hepatitis B surface antigen (HBsAg) negative, hepatitis B core antibody (HBcAb) positive, peripheral blood hepatitis B virus deoxyribonucleic acid (DNA) test \>0 IU/ml also ruled out;
- hepatitis C virus (HCV) antibody positive;
- human immunodeficiency virus (HIV) antibody positive;
- Treponema pallidum (Treponema pallidum, TP) antibody positive;
- anti nuclear antibody titer was 1:100 examination;
- drug abusers, alcohol addicts;
- , the researchers discretion of failure to follow the requirements of the program, instructions and research limitations, such as uncooperative attitude, unable to return to the Research Center for follow-up visits, or unable to complete the entire clinical study.
Key Trial Info
Start Date :
January 12 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 15 2018
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03357939
Start Date
January 12 2017
End Date
September 15 2018
Last Update
May 9 2022
Active Locations (1)
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1
the 1st affiliated hospital of Jilin University
Changchun, Jilin, China