NCT01343186

Brief Summary

This study is aimed to study the pharmacokinetic characteristics(e.g. AUC, Cmax, Tmax) of Ypeginterferon alfa-2a and interferon biomarkers(e.g. 2,5-OAS, neopterin) after single dose at different levels.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2011

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

January 31, 2012

Status Verified

December 1, 2010

Enrollment Period

4 months

First QC Date

April 24, 2011

Last Update Submit

January 30, 2012

Conditions

Healthy Subjects

Keywords

PeginterferonHealthy subjectPharmacokineticsPharmacodynamicsSafety

Outcome Measures

Primary Outcomes (2)

  • Measuring interferon levels in blood samples

    from 0 to 408 hours following injection

  • Different blood interferon biomarkers (such as 2,5-OAS, neopterin)

    from 0 to 408 hours following injection

Secondary Outcomes (2)

  • Adverse events

    up to 3 weeks following injection

  • Anti-interferon antibody

    baseline and week 2 after injection

Study Arms (4)

Arm 1

OTHER
Drug: Peginterferon alfa

Arm 2

OTHER
Drug: Peginterferon alfa 2a

Arm 3

OTHER
Drug: Peginterferon alfa-2a

Arm 4

OTHER
Drug: Peginterferon alfa-2a

Interventions

Peginterferon alfaDRUG

s,c, 45mcg of Ypeginterferon alfa-2a

Arm 1
Peginterferon alfa 2aDRUG

s,c, 90mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.

Arm 2
Peginterferon alfa-2aDRUG

s,c, 180mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.

Arm 3

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects
  • Age between 18 and 45, inclusive
  • Body mass index(BMI)between 19 and 26, inclusive
  • Sign informed consent

You may not qualify if:

  • Women of pregnant or lactation
  • Known hypersensitivity to interferon or any other components of the study drug
  • History of mental disease or genetic disease
  • History of diabetes mellitus, thyroid disease, cancer, autoimmune disease, organ transplant
  • Significant disease in heart, liver, kidney, lung or any other major organs
  • Alcoholic, smokers or drug abusers
  • Blood donation, or massive blood loss due to injury or surgery within 3 months
  • Other conditions which in the opinion of the investigator preclude enrollment into the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

302 Military Hospital of China

Beijing, 100039, China

Location

MeSH Terms

Interventions

peginterferon alfa-2a

Study Officials

  • Wei Zhenman, Ph.D

    Beijing 302 Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2011

First Posted

April 27, 2011

Study Start

January 1, 2011

Primary Completion

May 1, 2011

Study Completion

November 1, 2011

Last Updated

January 31, 2012

Record last verified: 2010-12

Locations

CN(1)