the goal this clinical trail is to evaluate the safety、Pharmacokinetic and immunogenicity of GR2102 injection。 Subjects will be enrolled in different groups in sequential order, and within each group will be randomly assigned to receive either GR2102 injection or placebo administration, with each Subjects will be enrolled in only one of these groups。
This is a randomized, double-blind, placebo-controlled, single-dose administration study to evaluate the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamic profile of GR2102 Injection in healthy adult Chinese subjects. After signing the informed consent form, subjects who meet the criteria for enrollment will be entered into different groups according to the randomization number.Subjects will be enrolled in only one of these groups. Only after the 8 subjects in the current group have completed at least 7 days of safety and tolerability observations and have been determined to be safe and tolerable, will another group of subjects be allowed to proceed to the next group . After completion of dosing, follow-up will be at least 150 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
132
single dose
single dose
The First Affiliated Hospital of Shandong First Medical University
Jinan, Shandong, China
RECRUITINGAdverse events
to characterise the safety and tolerability of GR2102,including abnormal vital signs,laboratory tests,electrocardiogram and physical examination
Time frame: 150 days post dose
Maximum Observed Serum Concentration
Pharmacokinetic indices
Time frame: 150 days post dose
Terminal Elimination Half Life
Pharmacokinetic indices
Time frame: 150 days post dose
anti-respiratory syncytial virus neutralizing antibodies titer levels
indicator of immunogenicity
Time frame: 150 days post dose
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