We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781753
First Posted: May 24, 2016
Last Update Posted: May 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tianjin SinoBiotech Ltd.
  Purpose
The purpose of this study is to evaluate the dosages of recombinant human serum albumin/interferon alpha2b fusion protein injection in healthy subjects.

Condition Intervention Phase
Healthy Biological: Human Serum Albumin/interferon alpha2b Biological: Peginterferon 180 μg single dose S.C. Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Tianjin SinoBiotech Ltd.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Pharmacokinetics of interferon after single dose [ Time Frame: 4 weeks ]
    Peak plasma concentration(Cmax)

  • Pharmacokinetics of interferon after single dose [ Time Frame: 4 weeks ]
    Area under the plasma concentration versus time curve (AUC)

  • Plasma concentration of Neopterin after single dose [ Time Frame: 4 weeks ]
    Plasma concentration of Neopterin after single dose

  • Pharmacokinetics of interferon after single dose [ Time Frame: 4 weeks ]
    Peak time(Tmax)

  • Pharmacokinetics of interferon after single dose [ Time Frame: 4 weeks ]
    Half-life period(T1/2)


Enrollment: 34
Actual Study Start Date: April 7, 2016
Study Completion Date: April 12, 2017
Primary Completion Date: August 2, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Human Serum Albumin/interferon alpha2b
Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C.
Biological: Human Serum Albumin/interferon alpha2b
Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C. at Day0
Active Comparator: Pegasys
Peginterferon 180 μg single dose S.C.
Biological: Peginterferon 180 μg single dose S.C.
Pegasys 180 mcg S.C. single dose on Day 0

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781753


Locations
China, Beijing
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing, China, 100069
Sponsors and Collaborators
Tianjin SinoBiotech Ltd.
Investigators
Principal Investigator: Meixia Wang, Professor Beijing YouAn Hospital
  More Information

Responsible Party: Tianjin SinoBiotech Ltd.
ClinicalTrials.gov Identifier: NCT02781753     History of Changes
Other Study ID Numbers: 921601
First Submitted: May 20, 2016
First Posted: May 24, 2016
Last Update Posted: May 8, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Interferons
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs