Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Pharmacokinetics and Pharmacodynamics Study of BCD-033 Compared to Rebif® in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Biocad
ClinicalTrials.gov Identifier:
NCT01766024
First received: January 10, 2013
Last updated: February 2, 2015
Last verified: February 2015
Results First Received: February 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Healthy
Intervention: Drug: Interferon beta-1a

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
BCD-033 → Rebif

Volunteers in this group initially will receive a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the reference drug Rebif® (interferon beta-1a) at a dose of 44 µg.

Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days.

Rebif → BCD-033

Volunteers in this group initially will receive a single sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg.

Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days.


Participant Flow:   Overall Study
    BCD-033 → Rebif     Rebif → BCD-033  
STARTED     16     16  
COMPLETED     16     16  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
BCD-033 → Rebif

Volunteers in this group initially will receive a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the reference drug Rebif® (interferon beta-1a) at a dose of 44 µg.

Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days.

Rebif → BCD-033

Volunteers in this group initially will receive a single sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg.

Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days.

Total Total of all reporting groups

Baseline Measures
    BCD-033 → Rebif     Rebif → BCD-033     Total  
Number of Participants  
[units: participants]
  16     16     32  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     16     16     32  
>=65 years     0     0     0  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     16     16     32  
>=65 years     0     0     0  
Gender  
[units: participants]
     
Female     0     0     0  
Male     16     16     32  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     16     16     32  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
Russian Federation     16     16     32  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Area Under Concentration-time Curve (AUC) of Interferon (IFN) Beta-1a From the Moment of Drug Administration Until 48 Hours and to Infinity(AUC(0-48) and AUC(0-∞) Respectively)   [ Time Frame: up to 48 h ]

2.  Primary:   Cmax of Interferon Beta-1a   [ Time Frame: up to 48 h ]

3.  Primary:   AUC(0-168) and AUC(0-∞) of Neopterin and MxA Protein   [ Time Frame: up to 168 h ]

4.  Secondary:   Тmax of Interferon Beta-1a   [ Time Frame: up to 48 h ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Т½ of Interferon Beta-1a   [ Time Frame: up to 48 h ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

6.  Secondary:   Кel of Interferon Beta-1a   [ Time Frame: up to 48 h ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

7.  Secondary:   Cl of Interferon Beta-1a   [ Time Frame: up to 48 h ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Cmax of Neopterin and MxA Protein   [ Time Frame: up to 168 h ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Tmax of Neopterin and MxA Protein   [ Time Frame: up to 168 h ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

10.  Secondary:   Adverse Event (AE) and Serious Adverse Event (SAE) Incidence   [ Time Frame: up to Day 43 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

11.  Secondary:   AE of Garde 3-4 Incidence   [ Time Frame: up to Day 43 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

12.  Secondary:   Local Reaction Incidence   [ Time Frame: up to Day 43 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes

13.  Secondary:   Study Withdrawal Rate Due to AE   [ Time Frame: up to Day 43 ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Director of Clinical Trials
Organization: BIOCAD
phone: 7 (812) 380 49 33 ext 925
e-mail: biryulin@biocad.ru


No publications provided


Responsible Party: Biocad
ClinicalTrials.gov Identifier: NCT01766024     History of Changes
Other Study ID Numbers: BCD-033-1
Study First Received: January 10, 2013
Results First Received: February 2, 2015
Last Updated: February 2, 2015
Health Authority: Russian Federation: Ministry of Health of the Russian Federation