Overview

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

Status:
Completed

Trial end date:
2019-07-15

Target enrollment:

Participant gender:

Summary

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.

Phase:

Phase 1

Details

Lead Sponsor:

PharmaEssentia Japan K.K.

Collaborator:

PharmaEssentia