[Translation] A randomized, double-blind, placebo-controlled phase I/II clinical study to evaluate the pharmacokinetics, pharmacodynamics, and safety of JL18008 injection in healthy adult subjects/patients with poor HIV immune reconstitution
Ia期
主要目的:评价JL18008注射液在健康成年受试者中单次肌肉注射的安全性、耐受性。
次要目的:评价JL18008注射液在健康成年受试者中单次肌肉注射的药代动力学(PK)特征;初步评价JL18008注射液在健康成年受试者中单次肌肉注射的药效动力学(PD)特征;初步评价JL18008注射液在健康成年受试者中单次肌肉注射的免疫原性。
[Translation] Phase Ia
Main purpose: To evaluate the safety and tolerability of a single intramuscular injection of JL18008 injection in healthy adult subjects.
Secondary purpose: To evaluate the pharmacokinetic (PK) characteristics of a single intramuscular injection of JL18008 injection in healthy adult subjects; To preliminarily evaluate the pharmacodynamic (PD) characteristics of a single intramuscular injection of JL18008 injection in healthy adult subjects; To preliminarily evaluate the immunogenicity of a single intramuscular injection of JL18008 injection in healthy adult subjects.