This is a randomized, double-blind, placebo-controlled Phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary pharmacodynamic characteristics of GR2301 injection in healthy adult subjects in China.The GR2301 injection dosage will be gradually increased. All healthy subjects will receive a single subcutaneous injection. Following administration, subjects will be followed for at least 16 weeks ± 7 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
IL15 monoclonal antibody
Beijing Tongren Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Adverse events (AEs)
Incidence of AEs
Time frame: up to week16
Pharmacokinetics parameters
concentration of GR2301
Time frame: up to week16
Incidence of ADA.
Time frame: up to week16
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