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Completed

NCT Number: NCT01343186

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Assessment of Ypeginterferon Alfa-2a in Healthy Subjects

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.

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Key information

Conditions

Healthy Subjects

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

302 Military Hospital of China

Beijing, 100039, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Peginterferon alfa

Drug

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

Peginterferon Alfa 2a

Drug

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

Peginterferon alfa-2a

Drug

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

Primary outcomes

  1. Measuring interferon levels in blood samples

    Time frame: from 0 to 408 hours following injection

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

    Time frame: from 0 to 408 hours following injection

Secondary outcomes

  1. Adverse events

    Time frame: up to 3 weeks following injection

  2. Anti-interferon antibody

    Time frame: baseline and week 2 after injection

Sponsors and collaborators

Lead sponsor

Xiamen Amoytop Biotech Co., Ltd.

Industry

Registry information

Official study title

A Single-centre, Randomised, Positive-controlled, Single-dose, Dose-escalation Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Ypeginterferon Alfa-2a in Healthy Subjects

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 27, 2011
Registry last updated
Jan 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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