A Phase 1 Randomized,Double-Blind and Parallel Controlled Single-dose Clinical Trial of Pharmacokinetics, Safety, Tolerability and Immunogenicity of HLX03 Compared With Humira® From China Source in Chinese Healthy Male Subjects
Overview
- Phase
- Phase 1
- Intervention
- HLX03
- Conditions
- Immune System Disorder
- Sponsor
- Shanghai Henlius Biotech
- Enrollment
- 220
- Locations
- 1
- Primary Endpoint
- Maximum Concentration（Cmax） of Adalimumab After Single SC Injection of HLX03/Humira
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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 spourced,40 mg/0.8 mL injection with a single-use prefilled syringe). This study will involve sampling,pharmacokinetics, safety, tolerability and immunogenicity evaluation of drug levels following administration of HLX03 and the licensed adalimumab products.
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 Chinese health volunteers. All enrolled subjects will receive a single dose of HLX03 (40 mg）or Humira(adalimumab, 40 mg) in subcutaneous injectioin after randomization. The purpose of this study to prove the similarity in PK, Safety, tolerability and immunogenicity beween HLX03（adalimumab biosimilar） and China sourced Humira and provide evidence for Phase III comparison study. The blood will be collected before drug administration, and at 1 hr、4 hr、8 hr、24 hr (1d)、48 hr (2d)、72 hr (3d)、96 hr (4d)、、144 hr (6d)、192 hr (8d)、240 hr (10d)、 336 hr (14d)、504 hr (21d)、672 hr (28d)、840 hr (35d)、1008 hr (42d)、1176 hr (49d)、1344 hr (56d)、1680 hr (70d) after drug injection for PK, ADA, etc analysis. All subjects also will be followed up at 0, 1,2,3,4,6,8,10,14,21,28,35, 42, 49, 56, and 70 days after drug administration for AE and other specified outcomes. The main endpoint is AUC from time zero to ∞. The second endpoints include Cmax, Tmax, T1/2, CL, Vd and AUC（0-last）. This is single center study in China.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •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;
Arms & Interventions
HLX03
There are about 68 subjects in this group will receive a single dose of 40 mg of HLX03 in 0.8 mL in subcutaneous injection.
Intervention: HLX03
Humira
There are about 68 subjects in this group will receive a single dose of 40 mg of Humira in a pre-filled syringe in subcutaneous injection.
Intervention: adalimumab
Outcomes
Primary Outcomes
Maximum Concentration（Cmax） of Adalimumab After Single SC Injection of HLX03/Humira
Time Frame: 71 days post-dose
Area Under the Plasma Concentration-time Curve From Zero (0) Hours to the last quantifiable concentration
Time Frame: 71 days post-dose
Secondary Outcomes
- Half-life time of adalimumab after single SC injection of HXL03/Humira(71 days)
- Area Under the Plasma Concentration-time Curve From Zero (0) to Time Infinity(71 days post-dose)
- Time to Maximum Concentration（Tmax） of Adalimumab After Single SC Injection(71 days post-dose)