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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01901198

Enrollment

Registered

2013-07-17

Start date

2013-04-30

Completion date

2013-12-31

Last updated

2014-11-17

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

Conditions

Healthy Volunteers

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.

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.

Interventions

BIOLOGICALHuman 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

BIOLOGICALPeginterferon 180 mcg 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 Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Number of participants with adverse events after single dose	4 weeks

Secondary

Measure	Time frame
Plasma concentration of interferon after single dose	4 weeks
Plasma concentration of Neopterin after single dose	4 weks

Countries

China

Outcome results

None listed

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