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

NCT03546465 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2019-11-26

No results posted yet for this study

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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

ropeginterferon alfa-2b

6 subjects in each cohort will receive a single dose by subcutaneous injection

Sponsors & Collaborators

  • PharmaEssentia

    collaborator INDUSTRY

  • PharmaEssentia Japan K.K.

    lead INDUSTRY

Principal Investigators

  • Jason Lickliter, MD · Nucleus Network Ltd

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-07
Primary Completion
2019-07-15
Completion
2019-07-15
FDA Drug
Yes

Countries

  • Australia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03546465 on ClinicalTrials.gov