It is a randomized, double-blinded, parallel, single-dose, Phase I comparative study to evaluate the pharmacokinetic, safety, and immunogenicity similarity between 9MW4113 and Dupixent® in healthy Chinese adult participants. A total of 208 healthy participants are planned to be included and randomized at a ratio of 1:1 to receive single 300mg/2.0ml 9MW4113 injection or Dupixent®.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
208
"9MW4113 injection; 300mg/2.0mL; subcutaneous injection.
"Dupixent®; 300mg/2.0mL; subcutaneous injection.
Wuhan Jinyintan Hospital(Wuhan Infectious Disease Hospital)
Wuhan, Hubei, China
Pharmacokinetics Endpoint
Maximum Concentration (Cmax)
Time frame: 0-9weeks
Pharmacokinetics Endpoint
Area under the concentration-time curve time 0 to infinity (AUC0-∞)
Time frame: 0-9weeks
Pharmacokinetics Endpoint
Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC0-t)
Time frame: 0-9weeks
Pharmacokinetics Endpoint
Time of maximum concentration (Tmax)
Time frame: 0-9weeks
Pharmacokinetics Endpoint
Terminal elimination rate constant (λz)
Time frame: 0-9weeks
Pharmacokinetics Endpoint
Terminal elimination half-life (t1/2z), t1/2z = ln2/λz
Time frame: 0-9weeks
Pharmacokinetics Endpoint
Percentage of extrapolated area (AUC\_%Extrap), AUC\_%Extrap = \[(AUC0-∞-AUC0-t)/AUC0-∞\]×100%
Time frame: 0-9weeks
Pharmacokinetics Endpoint
Apparent clearance (CL/F), CL/F=Dose/AUC0-∞
Time frame: 0-9weeks
Pharmacokinetics Endpoint
Apparent volume of distribution (Vd/F) , Vd/F = (CL/F)/λz
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Time frame: 0-9weeks
Safety Assessments
adverse events, concomitant medications, concomitant non-drug therapies, injection site irritation assessment, laboratory tests (complete blood count, blood biochemistry test, urinalysis and coagulation function) clinical symptoms, vital signs , 12 lead ECGs, physical examination
Time frame: 0-9weeks
Incidence of anti-drug antibodies (ADA)
Time frame: 0-9weeks
Titer of anti-drug antibodies (ADA)
Time frame: 0-9weeks
Incidence of neutralizing antibodies (NAb)
Time frame: 0-9weeks