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Trial record 51 of 1274 for:    IFNA2

Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase I Study in Chinese Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT01901198
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : November 17, 2014
Sponsor:
Information provided by (Responsible Party):
Beijing Bio-Fortune Ltd.

Brief Summary:
This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein single dose in Chinese healthy volunteers.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Biological: Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C. Biological: Peginterferon 180 mcg single dose S.C. Phase 1

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 alpha2a Fusion Protein in healthy subjects. Subjects will receive a single dose of Recombinant Human Serum Albumin/interferon alpha2a 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
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 alpha2a Fusion Protein in Healthy Volunteers
Study Start Date : April 2013
Actual Primary Completion Date : September 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Human Serum Albumin/interferon alpha2a
Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C.
Biological: Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C.
Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein 300-1200 mcg at Day 0

Active Comparator: Pegasys
Peginterferon 180 mcg single dose S.C.
Biological: Peginterferon 180 mcg single dose S.C.
Pegasys 180 mcg S.C. single dose on Day 0




Primary Outcome Measures :
  1. Number of participants with adverse events after single dose [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Plasma concentration of interferon after single dose [ Time Frame: 4 weeks ]
  2. Plasma concentration of Neopterin after single dose [ Time Frame: 4 weks ]


Information from the National Library of Medicine

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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

Other protocol-defined inclusion/exclusion criteria may apply


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): NCT01901198


Locations
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China, Beijing
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing, China, 100069
Sponsors and Collaborators
Beijing Bio-Fortune Ltd.
Investigators
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Principal Investigator: Ning Li, MD Beijing YouAn Hospital

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Responsible Party: Beijing Bio-Fortune Ltd.
ClinicalTrials.gov Identifier: NCT01901198     History of Changes
Other Study ID Numbers: 921301
First Posted: July 17, 2013    Key Record Dates
Last Update Posted: November 17, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
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Interferons
Interferon-alpha
Interferon alpha-2
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs