NCT03546465 is a Phase 1 clinical trial of ropeginterferon alfa-2b in Healthy Volunteers, sponsored by PharmaEssentia Japan K.K..

Who is sponsoring NCT03546465?

NCT03546465 is sponsored by PharmaEssentia Japan K.K..

What drugs are being tested in NCT03546465?

Interventions in NCT03546465: ropeginterferon alfa-2b.

What condition does NCT03546465 study?

NCT03546465 studies Healthy Volunteers.

Is NCT03546465 still recruiting?

NCT03546465 is currently completed. Last updated 26 November 2019.

Last reviewed 2019-11-26 · How we verify

NCT03546465

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 1 Last updated 26 November 2019

What this trial tests

Phase 1 trial testing ropeginterferon alfa-2b in Healthy Volunteers in 36 participants. Completed in 15 July 2019.

Timeline

7 May 2018

Primary endpoint
15 July 2019

15 July 2019

Quick facts

Lead sponsor	PharmaEssentia Japan K.K.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	36
Start date	7 May 2018
Primary completion	15 July 2019
Estimated completion	15 July 2019
Sites	1 location across Australia

Drugs / interventions tested

ropeginterferon alfa-2b (ROPEGINTERFERON ALFA-2B) — full drug profile →

Conditions studied

Healthy Volunteers — all drugs for Healthy Volunteers →

Sponsor

PharmaEssentia Japan K.K. — full company profile →

Who can join

Adults 21 to 50, male only, with Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

An alternative dosing strategy for ropeginterferon alfa-2b may help improve outcomes in myeloproliferative neoplasms: An overview of previous and ongoing studies with perspectives on the future.
Qin A, Urbanski RW, Yu L, Ahmed T, et al · · 2023 · cited 26× · PMID 36776307 · DOI 10.3389/fonc.2023.1109866
Pharmacokinetics and Pharmacodynamics of Ropeginterferon Alfa-2b in Healthy Japanese and Caucasian Subjects After Single Subcutaneous Administration.
Miyachi N, Zagrijtschuk O, Kang L, Yonezu K, et al · · 2021 · cited 23× · PMID 33725322 · DOI 10.1007/s40261-021-01026-5
SOHO State of the Art Update and Next Questions: Novel Therapies for Polycythemia Vera.
Masarova L, Chifotides HT. · · 2024 · cited 5× · PMID 38135633 · DOI 10.1016/j.clml.2023.11.004
Population Pharmacokinetics-Pharmacodynamics and Exposure-Response of Ropeginterferon Alfa-2b in Chinese and Japanese Patients With Polycythemia Vera.
Qin A, Shimoda K, Suo S, Fu R, et al · · 2025 · cited 4× · PMID 40313042 · DOI 10.1002/prp2.70109

Verify or expand the search:

Other recruiting trials for Healthy Volunteers

Currently open trials in the same condition.

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NCT07495813 — A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease · Phase 1 · recruiting
NCT07499050 — A Study of Multiple Doses of Orally Administered RO7795081 in Otherwise Healthy Chinese Adult Participants With Obesity · Phase 1 · recruiting
NCT07342114 — A Dose-Escalation Study of RO7875913 in Healthy Participants · Phase 1 · recruiting

Other PharmaEssentia Japan K.K. trials

Trials by the same sponsor.

NCT06002490 — A Study to Evaluate P1101 in Japanese PV Patients · Phase 3 · completed
NCT04655092 — Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients · Phase 3 · recruiting
NCT04182100 — Efficacy and Safety of P1101 in Polycythemia Vera Patients for Whom the Standard of Treatment is Difficult to Apply · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03546465 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by PharmaEssentia Japan K.K.
Last refreshed: 26 November 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03546465.

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