Completed PHASE1 INTERVENTIONAL 8-arm 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

Sponsor: PharmaEssentia

Conditions Healthy Volunteers

Interventions ropeginterferon alfa-2b

Updated 5 times since 2018 Last updated: Nov 22, 2019 Started: May 7, 2018 Primary completion: Jul 15, 2019 Completion: Jul 15, 2019

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates Healthy Volunteers and is currently completed. PharmaEssentia leads this study, which shows 5 recorded versions since 2018 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE1
Jul 2024 — Sep 2024 [monthly]

Completed PHASE1
Jan 2021 — Jul 2024 [monthly]

Completed PHASE1
Dec 2019 — Jan 2021 [monthly]

Completed PHASE1

Status: Recruiting → Completed
Jul 2018 — Dec 2019 [monthly]

Recruiting PHASE1

First recorded

May 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

PharmaEssentia
PharmaEssentia Japan K.K.

Data source: PharmaEssentia Japan K.K.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Melbourne, Australia