The humanized recombinant anti-CD6 monoclonal antibody Injection (T1h) has been approved for psoriasis in India. The first trial in China is to evaluate the tolerability, safety, pharmacodynamic, pharmacokinetics and preliminary efficacy of T1h for patients with psoriasis.
The humanized recombinant anti-CD6 monoclonal antibody (T1h) is developed whose ligand binding properties of the original murine monoclonal antibody are preserved on the CD6 molecule. T1h monoclonal antibody has been approved for clinical studies of autoimmune diseases in Cuba and India, such as psoriasis and rheumatoid arthritis (RA). Single and multiple dose based tolerability, safety and pharmacokinetic phase 1 Study of Humanized Anti-CD6 Monoclonal Antibody Injection in Chinese patients with psoriasis, 40 patients are enrolled. They are divided into 4 groups (0.2mg/kg, 0.4mg/kg, 0.8mg/kg, 1.6mg/kg) and each group includes 10 patients. First, these doses are all single-dose administration gradually from low then the doses 0.4mg/kg, 0.8mg/kg and 1.6mg/kg are multi-dose administration gradually from low.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Given T1h for different groups by vein to evaluate safety and tolerability;Collecting blood samples for pharmacokinetics and pharmacodynamics after administration.
Beijing Chao-Yang Hospital
Beijing, Beijing Municipality, China
Adverse events
Time frame: from patients with informed consents to 30 days after the last administration
single-dose ,Peak plasma concentration (Cmax) of T1h
Time frame: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose, Area under the plasma concentration versus time curve( AUC(0-t)) of T1h
Time frame: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose, Area under the plasma concentration versus time curve(AUC(0-∞))of T1h
Time frame: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose, Time to peak(Tmax) of T1h
Time frame: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose,Elimination rate constant (kel)of T1h
Time frame: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose,Half time (t1/2) of T1h
Time frame: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose,Total body clearance (CLs)of T1h
Time frame: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
single-dose,Apparent volume of distribution(Vd) of T1h
Time frame: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
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single-dose,Mean residence time(MRT) of T1h
Time frame: -2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after administration
multiple dose,Time to peak(Tmax) of T1h
Time frame: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose,Peak plasma concentration in steady state(Css_max) of T1h
Time frame: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose,Minimum plasma concentration in steady state(Css_min) of T1h
Time frame: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose,Average plasma concentration in steady state(Css_avg) of T1h
Time frame: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose, Area under the plasma concentration versus time curve in steady state(AUCss) of T1h
Time frame: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose,Apparent volume of distribution in steady state (Vss) of T1h
Time frame: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose,Degree of fluctuation (DF) of T1h
Time frame: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
multiple dose,Accumulation Index(AI) of T1h
Time frame: -2h,0h at week5,6,7,8,9,10,11,12;2h、-1h、-0.5h、0h、1h、2h、6h、12h、24h、2d、3d、7d、14d、21d、28d after week13
Erythrocyte sedimentation rate(ESR)
Time frame: week7,9 at -2h;week13 at -2h,24h,7d,14d,21d,28d after administration
C-reactive protein(CRP)
Time frame: week7,9 at -2h;week13 at -2h,24h,7d,14d,21d,28d after administration
Tumor Necrosis Factor -alpha(TNF-α)
Time frame: week7,9 at -2h;week13 at -2h,24h,7d,14d,21d,28d after administration
Interleukin (il)-6 (IL-6)
Time frame: week7,9 at -2h;week13 at -2h,24h,7d,14d,21d,28d after administration
interferon--γ (IFN-γ)
Time frame: week7,9 at -2h;week13 at -2h,24h,7d,14d,21d,28d after administration
CD6
Time frame: week7,9 at -2h;week13 at -2h,24h,7d,14d,21d,28d after administration
Psoriasis Area and Severity Index(PASI)
Time frame: at the end of 4th week,8th week,12th week after administration
Physician's Global Assessment(PGA)
Time frame: The 29th day,The 57th day,The 85th day and The 113th day after administration
Body surface area(BSA)
Time frame: The 29th day,The 57th day,The 85th day and The 113th day after administration