NCT01901198

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for phase_1 healthy-volunteers

Timeline
Completed

Started Apr 2013

Typical duration for phase_1 healthy-volunteers

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

April 1, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

April 9, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

November 17, 2014

Status Verified

November 1, 2014

Enrollment Period

5 months

First QC Date

April 9, 2013

Last Update Submit

November 14, 2014

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse events after single dose

    4 weeks

Secondary Outcomes (2)

  • Plasma concentration of interferon after single dose

    4 weeks

  • Plasma concentration of Neopterin after single dose

    4 weks

Study Arms (2)

Human Serum Albumin/interferon alpha2a

EXPERIMENTAL

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.

Pegasys

ACTIVE COMPARATOR

Peginterferon 180 mcg single dose S.C.

Biological: Peginterferon 180 mcg single dose S.C.

Interventions

Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C.BIOLOGICAL

Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein 300-1200 mcg at Day 0

Human Serum Albumin/interferon alpha2a
Peginterferon 180 mcg single dose S.C.BIOLOGICAL

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

Pegasys

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing YouAn Hospital, Capital Medical University

Beijing, Beijing Municipality, 100069, China

Location

MeSH Terms

Interventions

Serum Albumin, HumanInterferon alpha-2

Intervention Hierarchy (Ancestors)

Serum AlbuminAlbuminsProteinsAmino Acids, Peptides, and ProteinsBlood ProteinsInterferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesBiological Factors

Study Officials

  • Ning Li, MD

    Beijing YouAn Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2013

First Posted

July 17, 2013

Study Start

April 1, 2013

Primary Completion

September 1, 2013

Study Completion

December 1, 2013

Last Updated

November 17, 2014

Record last verified: 2014-11

Locations

CN(1)