Healthy Volunteers Clinical Trial
Official title:
A Dose-Block Randomized, Placebo Controlled (Double-blind), Active Controlled(Open-label), Dose-escalation Study to Investigate the Tolerability, and Pharmacokinetics/Pharmacodynamics of HL2351 After a Single Subcutaneous Administration in Healthy Male Subjects
The study design of this trial is a Dose-Block Randomized, Placebo controlled (Double-blind), Active Controlled(Open-label), Dose-escalation.
- Extended in vivo half-life of HL2351 is also anticipated to provide improved
therapeutic efficacy based on sustained maintenance of an effective concentration.
- A safety concern may be addressed by utilizing IL-1Ra that is being used after getting
approval by the EMA and the US FDA and known to be relatively safe, and the Fc fusion
technology that has been already applied to various therapeutic agents.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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