Trial Outcomes & Findings for Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers (NCT NCT04238663)

NCT ID: NCT04238663

Last Updated: 2023-10-25

Results Overview

To compare the pharmacokinetic (PK) profiles of MB02, US Avastin® and EU Avastin® (in terms of Cmax) to establish bioequivalence between the 3 study arms. For the PK similarity assessments, regulatory guidelines on bioequivalence were followed whereby two treatments are judged not to be different from one another if the 90% confidence interval (CI) for the geometric LS means ratios are fully contained within the predefined bioequivalence limits of 0.80 to 1.25.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 115 participants
• Primary outcome timeframe: Predose, 1.5 hours (end of infusion), 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose on Day 3-8, Day 10, Day 14, Day 21, Day 28, Day 42, Day 56, Day 78, and Day 100.
• Results posted on: 2023-10-25

Participant Flow

One subject in the US Avastin arm withdrew before receiving any study treatment.

Participant milestones

Measure	MB02 (Bevacizumab Biosimilar) Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	EU Approved Avastin® Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	US Licenced Avastin® Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion
Overall Study STARTED	38	38	38
Overall Study COMPLETED	38	37	38
Overall Study NOT COMPLETED	0	1	0

Reasons for withdrawal

Measure	MB02 (Bevacizumab Biosimilar) Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	EU Approved Avastin® Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	US Licenced Avastin® Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion
Overall Study Lost to Follow-up	0	1	0

Baseline Characteristics

Pharmacokinetic Study Comparing MB02 And US And EU Avastin® In Healthy Male Volunteers

Baseline characteristics by cohort

Measure	MB02 (Bevacizumab Biosimilar) n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	EU Approved Avastin® n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	US Licenced Avastin® n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	Total n=114 Participants Total of all reporting groups
Age, Continuous	39.4 years STANDARD_DEVIATION 10.18 • n=5 Participants	41.6 years STANDARD_DEVIATION 11.10 • n=7 Participants	38.3 years STANDARD_DEVIATION 9.64 • n=5 Participants	39.8 years STANDARD_DEVIATION 10.33 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	38 Participants n=7 Participants	38 Participants n=5 Participants	114 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	37 Participants n=7 Participants	37 Participants n=5 Participants	112 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 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	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	36 Participants n=5 Participants	35 Participants n=7 Participants	37 Participants n=5 Participants	108 Participants n=4 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Body mass index (BMI)	24.48 kg/m^2 STANDARD_DEVIATION 2.723 • n=5 Participants	24.59 kg/m^2 STANDARD_DEVIATION 2.322 • n=7 Participants	24.80 kg/m^2 STANDARD_DEVIATION 2.712 • n=5 Participants	24.62 kg/m^2 STANDARD_DEVIATION 2.573 • n=4 Participants

PRIMARY outcome

Timeframe: Predose, 1.5 hours (end of infusion), 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose on Day 3-8, Day 10, Day 14, Day 21, Day 28, Day 42, Day 56, Day 78, and Day 100.

To compare the pharmacokinetic (PK) profiles of MB02, US Avastin® and EU Avastin® (in terms of Cmax) to establish bioequivalence between the 3 study arms. For the PK similarity assessments, regulatory guidelines on bioequivalence were followed whereby two treatments are judged not to be different from one another if the 90% confidence interval (CI) for the geometric LS means ratios are fully contained within the predefined bioequivalence limits of 0.80 to 1.25.

Outcome measures

Measure	MB02 (Bevacizumab Biosimilar) n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	EU Approved Avastin® n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	US Licenced Avastin® n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion
Cmax: Maximum Observed Serum Concentration	86100 (ng/mL)/(mg/mL) Geometric Coefficient of Variation 24.8	81100 (ng/mL)/(mg/mL) Geometric Coefficient of Variation 20.0	87500 (ng/mL)/(mg/mL) Geometric Coefficient of Variation 24.9

PRIMARY outcome

Timeframe: Predose, 1.5 hours (end of infusion), 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose on Day 3-8, Day 10, Day 14, Day 21, Day 28, Day 42, Day 56, Day 78, and Day 100.

To compare the pharmacokinetic (PK) profiles of MB02, US Avastin® and EU Avastin® (in terms of AUC[0-∞]) to establish bioequivalence between the 3 study arms. For the PK similarity assessments, regulatory guidelines on bioequivalence were followed whereby two treatments are judged not to be different from one another if the 90% confidence interval (CI) for the geometric least square means (GLSM) ratios are fully contained within the predefined bioequivalence limits of 0.80 to 1.25.

Outcome measures

Measure	MB02 (Bevacizumab Biosimilar) n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	EU Approved Avastin® n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	US Licenced Avastin® n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion
AUC(0-∞); Area Under the Serum Concentration-time Curve From Time Zero to Infinity	30700000 ng*h/mL Geometric Coefficient of Variation 16.2	28800000 ng*h/mL Geometric Coefficient of Variation 16.4	30700000 ng*h/mL Geometric Coefficient of Variation 12.9

SECONDARY outcome

Timeframe: Predose, 1.5 hours (end of infusion), 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose on Day 3-8, Day 10, Day 14, Day 21, Day 28, Day 42, Day 56, Day 78, and Day 100.

To evaluate and compare the tmax of MB02, US Avastin® and EU Avastin® .

Outcome measures

Measure	MB02 (Bevacizumab Biosimilar) n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	EU Approved Avastin® n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	US Licenced Avastin® n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion
Tmax: Time of Maximum Observed Serum Concentration	4.0 hours Interval 1.5 to 8.0	4.0 hours Interval 1.5 to 11.9	4.0 hours Interval 1.5 to 12.0

SECONDARY outcome

Timeframe: Predose, 1.5 hours (end of infusion), 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose on Day 3-8, Day 10, Day 14, Day 21, Day 28, Day 42, Day 56, Day 78, and Day 100.

To evaluate and compare the AUC[0-t] of MB02, US Avastin® and EU Avastin®.

Outcome measures

Measure	MB02 (Bevacizumab Biosimilar) n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	EU Approved Avastin® n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	US Licenced Avastin® n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion
AUC(0 t)= Area Under the Serum Concentration-time Curve From Time Zero to the Time of the Last Observable Concentration.	29900000 ng*h/mL Geometric Coefficient of Variation 15.6	27900000 ng*h/mL Geometric Coefficient of Variation 16.0	29900000 ng*h/mL Geometric Coefficient of Variation 12.5

SECONDARY outcome

Timeframe: Predose, 1.5 hours (end of infusion), 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose on Day 3-8, Day 10, Day 14, Day 21, Day 28, Day 42, Day 56, Day 78, and Day 100.

To evaluate the CL of MB02, US Avastin® and EU Avastin®

Outcome measures

Measure	MB02 (Bevacizumab Biosimilar) n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	EU Approved Avastin® n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	US Licenced Avastin® n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion
CL: Total Body Drug Clearance After IV Administration	0.00770 l/hour Geometric Coefficient of Variation 18.1	0.00823 l/hour Geometric Coefficient of Variation 18.5	0.00766 l/hour Geometric Coefficient of Variation 16.2

SECONDARY outcome

Timeframe: Predose, 1.5 hours (end of infusion), 2, 3, 4, 5, 6, 8, 12, 24 hours post-dose on Day 3-8, Day 10, Day 14, Day 21, Day 28, Day 42, Day 56, Day 78, and Day 100.

To evaluate the t1/2 of MB02, US Avastin® and EU Avastin®

Outcome measures

Measure	MB02 (Bevacizumab Biosimilar) n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	EU Approved Avastin® n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	US Licenced Avastin® n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion
t1/2: Apparent Serum Terminal Elimination Half-life	443 hours Geometric Coefficient of Variation 16.9	444 hours Geometric Coefficient of Variation 14.5	458 hours Geometric Coefficient of Variation 16.1

SECONDARY outcome

Timeframe: Day -1, Day 14, Day 28, Day 56, and Day 78

Incidence of anti-bevacizumab antibodies (ADA), including neutralizing antibodies (Nab). Subjects who tested positive at baseline are not included here.

Rows for ADA and nAb are not mutually exclusive, i.e. a participant could be included in more than one Row.

Outcome measures

Measure	MB02 (Bevacizumab Biosimilar) n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	EU Approved Avastin® n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	US Licenced Avastin® n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion
Immunogenicity: Number of Participants With Anti-bevacizumab Antibodies (Including Neutralizing Antibodies) ADA positive	12 participants	14 participants	9 participants
Immunogenicity: Number of Participants With Anti-bevacizumab Antibodies (Including Neutralizing Antibodies) NAb positive	1 participants	0 participants	2 participants

SECONDARY outcome

Timeframe: Day 1 - Day 100

Compare the incidence of Treatment-emergent Adverse Events (TEAEs) reported in each treatment arm. TEAEs were coded using the Medical Dictionary for Regulatory Activities (MedDRA version 22.0) and graded using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Outcome measures

Measure	MB02 (Bevacizumab Biosimilar) n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	EU Approved Avastin® n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	US Licenced Avastin® n=38 Participants Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion
Number of Participants With Treatment-emergent Adverse Events (Safety) Not related TEAEs	16 participants	12 participants	16 participants
Number of Participants With Treatment-emergent Adverse Events (Safety) Subjects with TEAEs	30 participants	25 participants	32 participants
Number of Participants With Treatment-emergent Adverse Events (Safety) Subjects with SAEs	0 participants	0 participants	0 participants
Number of Participants With Treatment-emergent Adverse Events (Safety) Subjects discontinued due to TEAEs	0 participants	0 participants	0 participants
Number of Participants With Treatment-emergent Adverse Events (Safety) Unlikely-related TEAEs	4 participants	2 participants	4 participants
Number of Participants With Treatment-emergent Adverse Events (Safety) Possibly related TEAEs	10 participants	11 participants	12 participants
Number of Participants With Treatment-emergent Adverse Events (Safety) TEAEs of mild severity	20 participants	10 participants	23 participants
Number of Participants With Treatment-emergent Adverse Events (Safety) TEAEs of moderate severity	10 participants	14 participants	9 participants
Number of Participants With Treatment-emergent Adverse Events (Safety) TEAEs of severe severity	0 participants	1 participants	0 participants

Adverse Events

MB02 (Bevacizumab Biosimilar)

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

EU Approved Avastin®

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

US Licenced Avastin®

Serious events: 0 serious events

Other events: 32 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MB02 (Bevacizumab Biosimilar) n=38 participants at risk Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. MB02 (Bevacizumab Biosimilar): Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	EU Approved Avastin® n=38 participants at risk Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. EU approved Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion	US Licenced Avastin® n=38 participants at risk Sterile vial 400mg/16ml, single-dose 3mg/kg administered as 90-minute infusion on day 1. US licenced Avastin®: Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion
Infections and infestations Nasopharyngitis	36.8% 14/38 • Number of events 17 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	31.6% 12/38 • Number of events 12 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	34.2% 13/38 • Number of events 14 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.
Nervous system disorders Headache	13.2% 5/38 • Number of events 6 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	23.7% 9/38 • Number of events 14 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	15.8% 6/38 • Number of events 8 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.
Musculoskeletal and connective tissue disorders Back pain	5.3% 2/38 • Number of events 2 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	15.8% 6/38 • Number of events 6 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	2.6% 1/38 • Number of events 1 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.
Investigations Blood Creatine Phosphokinase Increased	7.9% 3/38 • Number of events 3 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	13.2% 5/38 • Number of events 5 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	0.00% 0/38 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.
Gastrointestinal disorders Diarrhea	0.00% 0/38 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	5.3% 2/38 • Number of events 2 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	7.9% 3/38 • Number of events 3 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.
Infections and infestations Pulpitis dental	5.3% 2/38 • Number of events 2 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	2.6% 1/38 • Number of events 1 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	5.3% 2/38 • Number of events 2 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.
Infections and infestations Rhinitis	10.5% 4/38 • Number of events 4 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	0.00% 0/38 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	0.00% 0/38 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.
Musculoskeletal and connective tissue disorders Arthralgia	2.6% 1/38 • Number of events 1 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	5.3% 2/38 • Number of events 3 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	2.6% 1/38 • Number of events 1 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	7.9% 3/38 • Number of events 3 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	0.00% 0/38 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	2.6% 1/38 • Number of events 1 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.
General disorders Fatigue	2.6% 1/38 • Number of events 2 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	2.6% 1/38 • Number of events 1 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	5.3% 2/38 • Number of events 2 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.
Investigations Aspartate aminotransferase increased	2.6% 1/38 • Number of events 1 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	5.3% 2/38 • Number of events 2 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	0.00% 0/38 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.
Musculoskeletal and connective tissue disorders Myalgia	5.3% 2/38 • Number of events 2 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	0.00% 0/38 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	2.6% 1/38 • Number of events 1 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/38 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	5.3% 2/38 • Number of events 4 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	2.6% 1/38 • Number of events 1 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.
Psychiatric disorders Sleep disorder	0.00% 0/38 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	5.3% 2/38 • Number of events 2 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	0.00% 0/38 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.
Respiratory, thoracic and mediastinal disorders Cough	5.3% 2/38 • Number of events 2 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	0.00% 0/38 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	0.00% 0/38 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.00% 0/38 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	0.00% 0/38 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	5.3% 2/38 • Number of events 2 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/38 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	0.00% 0/38 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.	5.3% 2/38 • Number of events 2 • Study duration (Day 1 - Day 100) Coded according to Medical Dictionary for Regulatory Activities (version 22.0), and graded on the basis of the US National Cancer Institute's Common Terminology for Adverse Events (version 5.0). Following a request from the Medicines and Healthcare products Regulatory Authority (MHRA) all serious adverse reactions were considered unexpected and reported as SUSARs, for the purpose of safety reporting in healthy volunteers.

Additional Information

Susana Millan

mAbxience Research SL

Phone: +34917711500

Email: susana.millan@mabxience.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place