The Evaluation of Safety, Tolerability and Pharmacokinetics/Pharmacodynamics of JPI-289 in Healthy Male Volunteers

Completed

Phase 1 Results N/A

Trial Description

Double blind, randomized, placebo control, multiple dose, dose escalation study

Detailed Description

A phase I clinical study, randomized, double-blind, placebo-controlled, multiple doses, dose escalation study of the safety, tolerability and pharmacokinetics/pharmacodynamics of JPI-289 in healthy male volunteers.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Placebo
    ARM 1: Kind: Experimental
    Label: Placebo
    Description: Each cohort, volunteer will be infused placebo for 60 min. (2 volunteers per each cohort, total 3 cohort)
  • JPI-289 Drug
    Intervention Desc: PARP-1 inhibitor
    ARM 1: Kind: Experimental
    Label: JPI-289
    Description: Each cohort, volunteers will be infused JPI-289 for 60 min. (6 volunteers per each cohort, total 3 cohort)

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Treatment
  • Endpoint: Pharmacokinetics/Dynamics Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary AUCτ,ss 96 hours No
Primary Cmax,ss 96 hours No
Primary Relative PAR level (%) 73 hours No
Secondary Cav,ss 96 hours No
Secondary t1/2β 96 hours No
Secondary Vd,ss 96 hours No
Secondary CL 96 hours No
Primary AUCτ,ss and Cmax,ss(76h), Relative PAR level(73h,%) 96 hours, 73 hours No

Sponsors