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

Information source: Beijing Bio-Fortune Ltd.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Volunteers

Intervention: Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C. (Biological); Peginterferon 180 mcg single dose S.C. (Biological)

Phase: Phase 1

Status: Completed

Sponsored by: Beijing Bio-Fortune Ltd.

Official(s) and/or principal investigator(s):
Ning Li, MD, Principal Investigator, Affiliation: Beijing YouAn Hospital

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Number of participants with adverse events after single dose

Secondary outcome:

Plasma concentration of interferon after single dose

Plasma concentration of Neopterin after single dose

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.

Eligibility

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Both.

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

Locations and Contacts

Beijing YouAn Hospital, Capital Medical University, Beijing, Beijing 100069, China
Additional Information

Starting date: April 2013
Last updated: November 14, 2014

Page last updated: August 23, 2015

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