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CompletedNCT02469987Updated Mar 25, 2022

Phase I - Pharmacokinetic Comparability Study in Healthy Male Volunteers

A Phase 1 interventional study of MYL-1402O and US marketed Avastin(R) in Healthy, sponsored by Mylan Inc.. Completed at 1 site in Netherlands. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-25.

Sponsored by Mylan Inc. (part of Viatris Inc.) · Phase 1, Interventional, and Other

Phase
Phase 1
Study type
Interventional
Enrollment
111
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study summary

Double-blind, single-dose, three-treatment, parallel group design PK comparability study of MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution (bevacizumab).

Read the detailed description

Double-blind, single-dose, three-treatment, parallel group design PK comparability study of MYL-1402O solution manufactured for Mylan compared to US and EU marketed Avastin® solution (bevacizumab) in a total of 111 healthy, adult male volunteers (37 subjects per treatment arm). After randomization, subjects will receive one of the following treatments: A single 1 mg/kg dose administered by i.v. infusion (25 mL over approximately 90 minutes) of MYL-1402O, an equivalent i.v. infusion of US marketed Avastin® (1 mg/kg), or an equivalent i.v. infusion of EU marketed Avastin® (1 mg/kg).

02

Conditions studied

  • Healthy

Keywords

  • safety
  • tolerability
  • immunogenicity
  • MYL-1402O
  • PK
  • Avastin®
  • biosimilarity
  • male
03

In context

Lead sponsor

Mylan Inc. is the lead sponsor of 44 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 9 (100%) have results posted.

First submitted before Mylan Inc. became part of Viatris Inc..

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Males aged 18-55 yrs. (inclusive)
  • BMI: 19.0 to 30.0 kg/m2 (inclusive)
  • Weight: ≥ 60kg and ≤100kg
  • Subjects should be willing to use adequate contraception and not donate sperm from admission to clinical research center until 6 months post dosing.
  • All intermittent medications should have be stopped at least 14days prior to admission to the clinical research center.
  • All intermittent non topical medication must be stopped at least 30days prior to admission to the clinical research center.
  • Ability and willingness to abstain from ETOH 48hrs prior to admission to the clinical research center.
  • Medical history without significant findings per the PI
  • Resting supine systolic BP of ≤140mmHg and diastolic BP of ≤90mmHg
  • ECGs (via 12 lead) showing NCS findings per PI
  • All clinical laboratory tests of blood and urine, WNL and/or without clinically significant findings
  • Willing/able to sign ICF
  • Normal bowel habits
  • Negative medical history regarding fecal blood positivity
  • Normal and/or NCS spot protein/creatinine (PCR) ratio.

Exclusion criteria

Exclusion Criteria:

  • Previous participation in the current study
  • History of prior exposure to bevacizumab
  • Evidence of clinically significant findings
  • Cognitive and / or mentally impaired handicaps that would affect ability to make an informed consent and/or remain compliant to the requirements of this trial.
  • History of relevant drug and/or food related allergies.
  • History of or known hypersensitivity to bevacizumab or other recombinant human or humanized antibodies or inactive ingredients.
  • Tobacco product use w/I 1 yr. prior to drug administration.
  • History of ETOH and or drug abuse/addiction
  • Positive urine drug and ETOH screen for opiates, methadone, cocaine, amphetamines including XTC, cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and ETOH.
  • Average intake of more than 24 units of ETOH / wk. (1 unit of ETOH equals \~250mL of beer, 100mL of wine or 35mL of spirits).
  • Consumption of any foods containing poppy seeds w/I 48 hrs. prior to screening and admission to the clinical research center
  • Positive screen for Hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies.
  • Participation in a drug study w/I 60days or 5 half-lives of the previous drug.
  • Participation in more than 3 other drug studies in the 10months prior to drug administration in the current protocol.
  • Donation or loss of more than 100mL of blood w/I 60days prior to drug administration. Donation or loss of more than 1.5liters of blood w/I the 10months prior to drug administration.
  • Strenuous exercise w/I 96 hrs. Prior to admission to the clinical research center.
  • Significant or acute illness w/I 5days prior to drug administration that may impact safety assessments per the judgement of the PI.
  • Unsuitable veins for infusion and/or venepuncture
  • Surgery including surgery with suturing via a dental procedure or would dehiscence w/I 28days of dosing. Any planned surgery or dental procedures during the study and for at least 30days after follow up.
  • Presence of a non-healing wound or fracture.
  • History of bleeding disorders
  • History of thromboembolic conditions
  • History of gastrointestinal perforations or any fistulae.
  • History of orthostatic hypotension, fainting spells, blackouts for any reasons.
  • History of hypertension
  • Medically significant dental disease or dental neglect with signs and or symptoms of local or systemic infection that would likely require a dental procedure during the course of study.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
111 participants (actual)

Study arms

  • Experimental
    MYL-1402O

    MYL-1402O (bevacizumab), single 1mg/kg i.v. infusion over 90 minutes.

    Drug: MYL-1402O

  • Active comparator
    US Marketed Avastin (R)

    US Marketed Avastin(R) (bevacizumab), single 1mg/kg i.v. infusion over 90 minutes.

    Drug: US marketed Avastin(R)

  • Active comparator
    EU Marketed Avastin(R)

    EU Marketed Avastin(R) (bevacizumab), single 1mg/kg i.v. infusion over 90 minutes.

    Drug: EU marketed Avastin(R)

Interventions

  • DrugMYL-1402O

    Treatment A - single 1mg/kg dose of MYL-14020 IV infusion over 90 mins.

    Also known as: Bevacizumab

  • Treatment B - single 1mg/kg dose of US marketed Avastin® IV infusion over 90mins

    Also known as: Bevacizumab

  • Treatment C - single 1mg/kg dose of EU marketed Avastin® IV infusion over 90mins.

    Also known as: Bevacizumab

06

What researchers measure

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC) for bevacizumab.

    Area under the plasma concentration versus time curve (AUC) for bevacizumab

    Time frame: pre-dose and 0.33, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, and 2352 hours after start of infusion.

Secondary outcomes

  1. Area under the plasma concentration versus time curve (AUC) for bevacizumab

    Area under the plasma concentration versus time curve (AUC) for bevacizumab

    Time frame: pre-dose and 0.33, 1, 1.5, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 120, 144, 168, 192, 264, 336, 504, 672, 1008, 1344, 1680, 2016, and 2352 hours after start of infusion.

Other outcomes

  1. Number of Participants with Adverse Events

    Number of Participants with Adverse Events

    Time frame: up to 99 days.

  2. Safety variable - immunogenicity

    Immunogenicity

    Time frame: Predose day 1, and days 15, 43, 71, and 99 post infusion

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Study locations

1 site
  • PRA Health Sciences - Early Development Services
    Zuidlaren, 9471 GP, Netherlands
08

References and documents

Publications

  • Hummel M, Bosje T, Shaw A, Liu MS, Barve A, Kothekar M, Socinski MA, Waller CF. A pharmacokinetics study of proposed bevacizumab biosimilar MYL-1402O vs EU-bevacizumab and US-bevacizumab. J Cancer Res Clin Oncol. 2022 Feb;148(2):487-496. doi: 10.1007/s00432-021-03628-0. Epub 2021 Apr 17. PubMed 33866430 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02469987
Lead sponsor
Mylan Inc.
Collaborators
Mylan GmbH
Responsible party
Sponsor
First posted
Jun 12, 2015
Start date
Apr 2015
Primary completion
Oct 2015
Completion
Oct 2015
Last update
Mar 25, 2022

Study contacts

Matthew A. Hummel, PhD
study director · Mylan Pharmaceuitcals Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.

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