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HealthyPhase 1NCT02469987

Phase I - Pharmacokinetic Comparability Study in Healthy Male Volunteers

A Phase 1 study testing MYL-1402O, US marketed Avastin(R) and EU marketed Avastin(R) in people with Healthy, run by Mylan Inc. at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
MYL-1402O, US marketed Avastin(R) and EU marketed Avastin(R)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
111 participants
Where
1 siteNetherlands
Study dates
Apr 2015to Oct 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • PRA Health Sciences - Early Development Services

    Zuidlaren, 9471 GP

Other trials in Netherlands

About this study

Official title: A Single Center, Randomized, Double-blind, 3-arm Parallel Phase1 Study to Assess PK, Safety, and Tolerability of a Single 90 Min iv Infusion of 1 mg/kg MYL-1402O, EU Avastin®, and US Avastin® in Healthy Male Volunteers

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).

Conditions
Healthy
Being tested
MYL-1402O, US marketed Avastin(R), EU marketed Avastin(R)
Keywords
safety, tolerability, immunogenicity, MYL-1402O, PK, Avastin®, biosimilarity, male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MYL-1402ODrug

    Also called Bevacizumab

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

  • US marketed Avastin(R)Drug

    Also called Bevacizumab

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

  • EU marketed Avastin(R)Drug

    Also called Bevacizumab

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

Study groups in NCT02469987
Study groupRoleWhat they receive
MYL-1402OExperimentalMYL-1402O (bevacizumab), single 1mg/kg i.v. infusion over 90 minutes.
Receives: Drug: MYL-1402O
US Marketed Avastin (R)Active comparatorUS Marketed Avastin(R) (bevacizumab), single 1mg/kg i.v. infusion over 90 minutes.
Receives: Drug: US marketed Avastin(R)
EU Marketed Avastin(R)Active comparatorEU Marketed Avastin(R) (bevacizumab), single 1mg/kg i.v. infusion over 90 minutes.
Receives: Drug: EU marketed Avastin(R)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 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)

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

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

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionOct 2015
  4. Study completionOct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02469987
Sponsor's protocol ID
MYL-1402O-1002
Other IDs
2014-005621-12, 2014
Status last verified
Mar 2022
First submitted
3 Jun 2015
Last updated
25 Mar 2022
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MYL-1402O, US marketed Avastin(R) and EU marketed Avastin(R) in people with Healthy, run by Mylan Inc. at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02469987, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.

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