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HealthyPhase 1NCT03131700

Bioequivalence and Safety Study of Bevacizumab-biosimilar (RPH-001) Compared to Bevacizumab-innovator

A Phase 1 study testing RPH001 and Avastin® in people with Healthy, run by TRPHARM.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this to assess pharmacokinetic bioequivalence between two bevacizumab products, RPH-001 (TRPHARM) and EU sourced Avastin® (Roche), after single IV administration at 5 mg/kg fixed dose. 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?
RPH001 and Avastin®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Dec 2017to Jan 2018
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

  • Healthy male subjects aged 18 to 55 years inclusive.
  • Adult healthy male subjects between 18.0 and 30.0 kg/m2 body mass index (inclusive) and body weight ≥ 60 kg and ≤ 100 kg (inclusive).

Who cannot join

  • Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, osteomuscular, articular, psychiatric, systemic, ocular, or infectious disease, or signs of acute illness.
  • Positive result on any of the following tests: hepatitis B surface (HBs Ag) antigen, anti hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus 1 and 2 antibodies (anti-HIV1 and anti HIV2 Ab).
  • Positive result on urine drug screen (amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
  • Positive alcohol test at screening or baseline visits

About this study

Official title: Phase I, Double Blind, Randomized, Parallel-Arm, Single-Dose, Bioequivalence and Safety Study of Bevacizumab-biosimilar (RPH-001) Compared to Bevacizumab-innovator (Avastin®, Roche) in Healthy Male Volunteers

The purpose of this to assess pharmacokinetic bioequivalence between two bevacizumab products, RPH-001 (TRPHARM) and EU sourced Avastin® (Roche), after single IV administration at 5 mg/kg fixed dose.

Conditions
Healthy
Being tested
RPH001, Avastin®
Keywords
RPH101, RPH-101, Biosimilar, Bevacizumab, Safety

What participants receive

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

  • RPH001Biological

    Avastin® has been approved for treatment of various cancers in many countries of the world including the USA, EU countries, and Turkey. In Turkey, Avastin® is approved with a different trade name, Altuzan®, for treatment of metastatic colorectal cancer.

  • Avastin®Biological

    Also called Bevacizumab

    R-Pharm created a biological analog of Avastin®, RPH-001. RPH-001 and Avastin® have similar physicochemical properties, pharmacokinetic profile and affinity to human vascular endothelial growth factor, similar toxicity and efficacy confirmed by preclinical study results.

Study groups in NCT03131700
Study groupRoleWhat they receive
RPH-001ExperimentalA single dose of RPH-001 will be administered (IV) 5 mg/kg dose .
Receives: Biological: RPH001
EU sourced Avastin®Active comparatorA single dose of Avastin® will be administered (IV) 5 mg/kg dose .
Receives: Biological: Avastin®

What is being measured

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

  1. Maximum plasma concentration

    Cmax

    Measured: Until 100 days after administration

  2. Area under concentration-time curve from time zero to the last sampling time

    Area Under the Curve - AUC(0-t)

    Measured: Until 100 days after administration

  3. Area under concentration-time curve from time zero to infinity

    Area Under the Curve - AUC(0-∞)

    Measured: Until 100 days after administration

Secondary outcomes (18)

  1. Concentration-time profiles

    RPH-001 and Avastin®

    Measured: Until 100 days after administration

  2. Time to maximum concentration (Tmax)

    RPH-001 and Avastin®

    Measured: Until 100 days after administration

  3. Terminal elimination half-life (t½)

    RPH-001 and Avastin®

    Measured: Until 100 days after administration

  4. Terminal elimination rate constant (λz)

    RPH-001 and Avastin®

    Measured: Until 100 days after administration

  5. Apparent volume of distribution (Vz)

    RPH-001 and Avastin®

    Measured: Until 100 days after administration

  6. Clearance (CL)

    Measured: Until 100 days after administration

  7. Volume of distribution at steady state (Vss)

    Measured: Until 100 days after administration

  8. Nature, frequency, severity and relationship to study drug of recorded adverse events

    Measured: Until 100 days after administration

  9. Physical examination

    Measured: Until 100 days after administration

  10. Heart rate

    Measured: Until 100 days after administration

  11. Blood Pressure

    Measured: Until 100 days after administration

  12. Respiratory rate

    Measured: Until 100 days after administration

  13. Oxygen saturation

    Measured: Until 100 days after administration

  14. Body temperature

    Measured: Until 100 days after administration

  15. ECG

    Measured: Until 100 days after administration

  16. Clinical laboratory tests

    Measured: Until 100 days after administration

  17. Anti-drug-antibody (ADA)

    Measured: Until 100 days after administration

  18. Neutralizing antibody (NAb)

    Measured: Until 100 days after administration

Timeline

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

  1. First posted27 Apr 2017
  2. Study startDec 2017 (estimated)
  3. Primary completionJan 2018 (estimated)
  4. Study completionJan 2018 (estimated)

Why it stopped: Decision of the Sponsor

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03131700
Sponsor's protocol ID
RPH001BEV01
Status last verified
Sep 2017
First submitted
19 Apr 2017
Last updated
12 Apr 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RPH001 and Avastin® in people with Healthy, run by TRPHARM.

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 2 inclusion and 4 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: withdrawn, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Maximum plasma concentration (time frame: Until 100 days after administration). The study lists 3 primary outcomes in all. 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 NCT03131700.

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 12 Apr 2018.

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