ClinicalTrials.Veeva

Menu

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

T

Tianjin SinoBiotech

Status and phase

Completed
Phase 1

Conditions

Healthy

Treatments

Biological: Peginterferon 180 μg single dose S.C.
Biological: Human Serum Albumin/interferon alpha2b

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

34 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

34 participants in 2 patient groups

Human Serum Albumin/interferon alpha2b
Experimental group
Description:
Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C.
Treatment:
Biological: Human Serum Albumin/interferon alpha2b
Pegasys
Active Comparator group
Description:
Peginterferon 180 μg single dose S.C.
Treatment:
Biological: Peginterferon 180 μg single dose S.C.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems