Trial Outcomes & Findings for Pharmacokinetics and Pharmacodynamics Study of BCD-033 Compared to Rebif® in Healthy Volunteers (NCT NCT01766024)

Results Overview

Primary outcome measure for pharmacokinetics analysis. Blood samples were taken before the injection, then after 15 min, 30 min, 45 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours and 48 hours.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

32 participants

Primary outcome timeframe

0 to 48 hours post-dose

Results posted on

2016-05-04

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	16	16
Overall Study COMPLETED	16	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BCD-033 → Rebif n=16 Participants 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 n=16 Participants 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 n=32 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	16 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Russian Federation	16 participants n=5 Participants	16 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: 0 to 48 hours post-dose

Primary outcome measure for pharmacokinetics analysis. Blood samples were taken before the injection, then after 15 min, 30 min, 45 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours and 48 hours.

Outcome measures

Outcome measures
Measure	BCD-033 n=30 Participants the endpoint was assessed in all the volunteer who received BCD-033	Rebif n=30 Participants the endpoint was assessed in all the volunteer who received Rebif
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)	6318.3 (pg/ml)•h Interval 5368.4 to 7484.9	6807.9 (pg/ml)•h Interval 5714.9 to 8920.1

PRIMARY outcome

Timeframe: 0 to 48 hours post-dose

Primary outcome measure for pharmacokinetics analysis Blood samples were taken before the injection, then after 15 min, 30 min, 45 min, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24 hours and 48 hours.

Outcome measures

Outcome measures
Measure	BCD-033 n=30 Participants the endpoint was assessed in all the volunteer who received BCD-033	Rebif n=30 Participants the endpoint was assessed in all the volunteer who received Rebif
Cmax of Interferon Beta-1a	104.9 pg/ml Interval 80.2 to 123.4	102.4 pg/ml Interval 83.6 to 148.6

PRIMARY outcome

Timeframe: 0 to 168 hours post-dose

Primary outcome measure for pharmacodynamics analysis. Blood samples were taken before the injection, then after 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 and 168 hours.

Outcome measures

Outcome measures
Measure	BCD-033 n=32 Participants the endpoint was assessed in all the volunteer who received BCD-033	Rebif n=32 Participants the endpoint was assessed in all the volunteer who received Rebif
AUC(0-168) and AUC(0-∞) of Neopterin and MxA Protein neopterin	552.7 (ng/ml)*h Interval 458.1 to 661.6	537.6 (ng/ml)*h Interval 392.6 to 680.1
AUC(0-168) and AUC(0-∞) of Neopterin and MxA Protein MxA protein	2444.2 (ng/ml)*h Interval 2005.5 to 3011.2	2131.2 (ng/ml)*h Interval 1728.0 to 3245.0

SECONDARY outcome

Timeframe: 0 to 48 hours post-dose

Secondary outcome measure for pharmacokinetics analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0 to 48 hours post-dose

Secondary outcome measure for pharmacokinetics analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0 to 48 hours post-dose

Secondary outcome measure for pharmacokinetics analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0 to 48 hours post-dose

Secondary outcome measure for pharmacokinetics analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0 to 168 hours post-dose

Secondary outcome measure for pharmacodynamics analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 0 to 168 hours post-dose

Secondary outcome measure for pharmacodynamics analysis

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to Day 43

Secondary outcome measure for safety assessment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to Day 43

Secondary outcome measure for safety assessment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to Day 43

Secondary outcome measure for tolerability assessment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to Day 43

Secondary outcome measure for safety assessment

Outcome measures

Outcome data not reported

Adverse Events

BCD-033

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Rebif

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	BCD-033 n=32 participants at risk the endpoint was assessed in all the volunteer who received BCD-033	Rebif n=32 participants at risk the endpoint was assessed in all the volunteer who received Rebif
General disorders Flu-like syndrom	100.0% 32/32 • Number of events 32	100.0% 32/32 • Number of events 32
General disorders Local reactions	40.6% 13/32 • Number of events 13	46.9% 15/32 • Number of events 15

Additional Information

Director of Clinical Trials

BIOCAD

Phone: 7 (812) 380 49 33

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER