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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02781753

Enrollment

Registered

2016-05-24

Start date

2016-04-07

Completion date

2017-04-12

Last updated

2017-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

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.

Interventions

BIOLOGICALHuman Serum Albumin/interferon alpha2b

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

BIOLOGICALPeginterferon 180 μg single dose S.C.

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Number of participants with adverse events after single dose	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

Measure	Time frame	Description
Pharmacokinetics of interferon after single dose	4 weeks	Peak plasma concentration(Cmax)
Plasma concentration of Neopterin after single dose	4 weeks	Plasma concentration of Neopterin after single dose

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026