To evaluate the pharmacokinetic (PK) characteristics and pharmacological effect of GR2002 injection in Chinese healthy volunteers
This is a randomized, double-blind, placebo-controlled phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics, preliminary pharmacodynamics, and immunogenicity characteristics of single subcutaneous administration of GR2002 injection in healthy adult Chinese subjects. The initial dose group is 35mg, and the subsequent doses will gradually increase. Only after all subjects in the current dose group have completed at least 2 weeks of safety and tolerance observation and confirmed safe tolerance, can they enter the next dose group for medication observation until the "dose increase termination standard" is reached. Follow up will be conducted for at least 12 weeks ± 3 days after completion of medication administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
one single dose of GR2002 injection
one single dose of placebo
Peking University People's Hospital
Beijing, China
Incidence of Adverse Events (AE)
Incidence of AEs, including any abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing
Time frame: 85 days
Pharmacokinetics (PK) parameter: Time to reach peak concentration (Tmax)
Time to reach peak concentration (Tmax)
Time frame: 85 days
Pharmacokinetics (PK) parameter : Peak Plasma concentration (Cmax)
Peak Plasma concentration (Cmax)
Time frame: 85 days
Pharmacodynamics (PD): Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration
Changes from baseline in serum thymus activation regulation chemokine (TARC) concentration after GR2002 administration
Time frame: 85 days
Immunogenicity: anti-drug antibody (ADA) and neutralizing antibody (Nab)
Detection of anti-drug antibody (ADA) and neutralizing antibody (Nab)
Time frame: 85 days
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