This is a single ascending dose study of 9MW3811, the primary objective of which is to evaluate the safety and tolerability of 9MW3811 in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Single dose intravenously infused on day 1
Single dose of matching placebo intravenously infused on day 1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGIncidence of adverse events (AEs) as assessed by CTCAE v5.0
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: up to Day113
Maximum Plasma Concentration (Cmax)
To determine the pharmacokinetic (PK) of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Time frame: up to Day113
Time to reach Cmax (Tmax)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Time frame: up to Day113
Area under the plasma concentration versus time curve (AUC) from time 0 to the last quantifiable concentration (AUC0-t)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Time frame: up to Day113
Terminal elimination half-life (t1/2)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Time frame: up to Day113
AUC from time 0 extrapolated to infinity (AUC0-inf)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Time frame: up to Day113
Terminal elimination rate constant (λz)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
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Time frame: up to Day113
Apparent clearance (CL)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Time frame: up to Day113
Volume of distribution (Vz)
To determine the PK of 9MW3811 following single ascending intravenous doses in healthy adult participants.
Time frame: up to Day113
Incidence of antidrug antibodies (ADA) at specified timepoints relative to baseline
To determine the immunogenicity of 9MW3811.
Time frame: up to Day113