This study is Safety, Tolerability and Pharmacokinetic of Recombinant anti-IL-5 Humanized Monoclonal Antibody injection in Healthy Subjects. There are 6 Groups as follows: 0.03mg/kg (S1), 0.2mg/kg (S2), 1.0mg/kg (S3), 3.0mg/kg (S4), 5.0mg/kg (S5) and 7.5mg/kg (S6); and 2 subjects were included in the S1 group (both received study drugs); 10 subjects were included in each of the S2 \~ S6 groups (of which 8 received study drugs and 2 received placebo). Pharmacokinetics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerance, efficacy and immunogenicity for healthy subjects will be evaluated.
This study is a randomized, double-blind, placebo-controlled parallel trial of safety, tolerability and pharmacokinetic of Recombinant anti-IL-5 Humanized Monoclonal Antibody by single subcutaneous injection with six different doses in healthy subjects. There are 6 groups as follows: 0.03mg/kg (S1), 0.2mg/kg (S2), 1.0mg/kg (S3), 3.0mg/kg (S4), 5.0mg/kg (S5) and 7.5mg/kg (S6); and 2 subjects were included in the S1 group (both received study drugs); 10 subjects were included in each of the S2 \~ S6 groups (of which 8 received study drugs and 2 received placebo). In each group, two subjects were sentinels (1 received the study drug and 1 placebo). Pharmacokinetics and Anti-drug antibody (ADA) data will be collected; Drug safety, tolerance, efficacy and immunogenicity for healthy subjects will be evaluated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
52
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGCmax
Maximum Plasma Concentration of 610
Time frame: up to 84 days
Tmax
Time to Maximum Plasma Concentration of 610
Time frame: up to 84 days
AUC
Area Under the Curve of 610
Time frame: up to 84 days
t1/2
Half life of 610 in blood
Time frame: up to 84 days
CL/F
Plasma clearance of 610
Time frame: up to 84 days
Vd/F
Apparent Volume of Distribution of 610
Time frame: up to 84 days
AE
To monitor adverse events (AEs) per the NCI CTCAE 5.0.
Time frame: up to 84 days
Immunogenicity
Percentage of ADA positive and determination of ADA titer as well as Nab
Time frame: up to 84 days
EOS
Compare the changes of EOS levels with the baseline
Time frame: up to 84 days
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