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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
220
A single dose of 40 mg HLX03 in 0.8 mL in subcutaneous injection.
A single dose of 40 mg Humira in 0.8 mL in a pre-filled syringe
the 1st affiliated hospital of Jilin University
Changchun, Jilin, China
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
Area Under the Plasma Concentration-time Curve From Zero (0) to Time Infinity
Time frame: 71 days post-dose
Time to Maximum Concentration(Tmax) of Adalimumab After Single SC Injection
Time frame: 71 days post-dose
Half-life time of adalimumab after single SC injection of HXL03/Humira
Time frame: 71 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.