Recombinant Human Serum Albumin/Interferon alpha2a Fusion Protein Phase I Study in Chinese Healthy Volunteers
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01901198|
Recruitment Status : Completed
First Posted : July 17, 2013
Last Update Posted : November 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Healthy Volunteers||Biological: Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C. Biological: Peginterferon 180 mcg single dose S.C.||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||April 2013|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||December 2013|
Experimental: Human Serum Albumin/interferon alpha2a
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.
Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein 300-1200 mcg at Day 0
Active Comparator: Pegasys
Peginterferon 180 mcg single dose S.C.
Biological: Peginterferon 180 mcg single dose S.C.
Pegasys 180 mcg S.C. single dose on Day 0
- Number of participants with adverse events after single dose [ Time Frame: 4 weeks ]
- Plasma concentration of interferon after single dose [ Time Frame: 4 weeks ]
- Plasma concentration of Neopterin after single dose [ Time Frame: 4 weks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01901198
|Beijing YouAn Hospital, Capital Medical University|
|Beijing, Beijing, China, 100069|
|Principal Investigator:||Ning Li, MD||Beijing YouAn Hospital|