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Completed

NCT Number: NCT02781753

Study of Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Chinese Healthy Volunteers

The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection in healthy subjects.

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Key information

Conditions

Healthy

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, 100069, China

About this study

This is an open-label study that will be conducted at a single site in China to characterize the PK/PD profile, safety and tolerability of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein in healthy subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2b Fusion Protein or active comparator Pegasys at Day 0. The total duration of study participation is up to 6 weeks for each subject. Subjects will complete a follow-up visit at Day 28 after the dosing.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Must be healthy males or females between 18 to 45 years old, inclusive
  • Must have a body mass index (BMI) of 19 to 25 kg/m2, inclusive, and a minimum body weight of 50.0 kg

Exclusion criteria

  • History of any clinically significant laboratory abnormalities, cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases
  • Female subjects who are pregnant or breastfeeding
  • Any previous treatment with Human Albumin Interferon fusion protein

Treatment and study plan

Human Serum Albumin/interferon alpha2b

Biological

Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C. at Day0

Peginterferon 180 μg single dose S.C.

Biological

Pegasys 180 mcg S.C. single dose on Day 0

Primary outcomes

  1. Number of participants with adverse events after single dose

    Time frame: 4 weeks

    Frequency and severity of all adverse events on the part of the participants, including frequency and severity of drug-related adverse events.

Secondary outcomes

  1. Pharmacokinetics of interferon after single dose

    Time frame: 4 weeks

    Peak plasma concentration(Cmax)

  2. Pharmacokinetics of interferon after single dose

    Time frame: 4 weeks

    Area under the plasma concentration versus time curve (AUC)

  3. Plasma concentration of Neopterin after single dose

    Time frame: 4 weeks

    Plasma concentration of Neopterin after single dose

  4. Pharmacokinetics of interferon after single dose

    Time frame: 4 weeks

    Peak time(Tmax)

  5. Pharmacokinetics of interferon after single dose

    Time frame: 4 weeks

    Half-life period(T1/2)

Sponsors and collaborators

Lead sponsor

Tianjin SinoBiotech Ltd.

Industry

Registry information

Official study title

A Phase 1 Study to Evaluate the Pharmacokinetic and Pharmacodynamic Profile, Safety, and Tolerability of Escalating Single Dose Recombinant Human Serum Albumin/Interferon alpha2b Fusion Protein in Healthy Chinese Volunteers

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
May 24, 2016
Registry last updated
May 8, 2017

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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