Safety, Tolerability, Pharmacokinetics & Pharmacodynamics Study of Ropeginterferon Alfa-2b in Healthy Japanese and Caucasian Subjects

Sponsor
PharmaEssentia Japan K.K.
Study ID
NCT03546465
Phase
PHASE1
Status
Completed

Conditions

  • Healthy Volunteers

Eligibility Criteria

Sex
MALE
Age
21 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This is a Phase 1 single center, parallel group study to assess and compare the safety, tolerability, PK and PD of 4 single ascending doses of P1101 (100, 200, 300, and 450 μg) following subcutaneous administration in healthy Japanese and Caucasian subjects.

Key Dates

Start date
May 7, 2018
Status verified
Nov 2019
Primary completion
Jul 15, 2019
Completion
Jul 15, 2019

Study Design

Enrollment
36 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohorts 1C (Caucasian subjects)
    ropeginterferon alfa-2b: single dose of 100 μg
  • Experimental: Cohorts 1J (Japanese subjects)
    ropeginterferon alfa-2b: single dose of 100 μg
  • Experimental: Cohorts 2C (Caucasian subjects)
    ropeginterferon alfa-2b: single dose of 200 μg
  • Experimental: Cohorts 2J (Japanese subjects)
    ropeginterferon alfa-2b: single dose of 200 μg
  • Experimental: Cohorts 3C (Caucasian subjects)
    ropeginterferon alfa-2b: single dose of 300 μg
  • Experimental: Cohorts 3J (Japanese subjects)
    ropeginterferon alfa-2b: single dose of 300 μg
  • Experimental: Cohorts 4C (Caucasian subjects)
    ropeginterferon alfa-2b: single dose of 450 μg
  • Experimental: Cohorts 4J (Japanese subjects)
    ropeginterferon alfa-2b: single dose of 450 μg

Primary Outcome Measure

Adverse events after single dose [ Time Frame: Through study Day 35 ]

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