NCT03546465

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

A Phase 1 Bridging Study to Investigate and Compare the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Four Single Ascending Doses of Ropeginterferon Alfa-2b (P1101) in Healthy Japanese and Healthy Caucasian Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: PharmaEssentia Japan K.K. · Industry
• Sex: Male
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed description

Twenty-four healthy eligible Japanese male subjects and 24 healthy eligible Caucasian male subjects, each divided into 4 cohorts of 6 subjects, will participate in this study. No subject will participate in more than 1 cohort and all subjects will receive a single dose of P1101. Caucasian subjects will be body weight- and height-matched to Japanese subjects. Dosing will be initiated with the lowest dose of 100 μg in both Japanese and Caucasian subjects.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	ropeginterferon alfa-2b	6 subjects in each cohort will receive a single dose by subcutaneous injection

Timeline

• Start date: 2018-05-07
• Primary completion: 2019-07-15
• Completion: 2019-07-15
• First posted: 2018-06-06
• Last updated: 2019-11-26

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study