HealthyPhase 1NCT03659305
Pharmacokinetic Equivalence and Safety Study of RPH-001 and Avastin®
A Phase 1 study testing RPH-001 and Avastin in people with Healthy, run by R-Pharm at 1 site in Russia.
Trial summary
The purpose of this study is to confirm pharmacokinetic equivalence and compare clinical safety profile of RPH-001 and Avastin®. Read more about this study
- Who is it for?
- Ages 21 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- RPH-001 and Avastin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteRussia
- Study dates
- 10 Jul 2018to 26 Jan 2019
- 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 21 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Voluntarily signed informed consent form prior to any research procedure.
- Body Mass Index (BMI) between 18,5 and 30 kg/m^2, inclusively, and body mass between 60 and 100 kg, inclusively.
- Verified diagnosis "Healthy" according to standard clinical, laboratory and instrumental methods of examination, namely haemodynamic parameters within normal limits: systolic blood pressure in the range of 100 - 130 mm Hg inclusive, diastolic blood pressure in the range of 60 - 90 mm Hg inclusive, heart rate is 60-90 beats/minute inclusive (according to the physical examination); the absence of deviations from the norm in the results of laboratory and instrumental methods of examination, including ECG (normal standard electrocardiogram in 12 leads after 10 minutes of rest in the supine position should meet the following parameters: 120ms < PR < 200 ms, QRS<120 ms, QTc ≤ 430 ms).
- The ability of volunteer, according to the investigator, to comply with the Protocol procedures.
- The willingness of the volunteer and his sexual partner with the preserved reproductive function to use reliable methods of contraception from the day of hospitalization (Day -1) until the end of the follow-up period (Day 100). This requirement does not apply to participants who underwent surgical sterilization. Reliable methods of contraception suggest the use of the 1-st barrier method in combination with one of the following: spermicide, intrauterine device/oral contraceptives in the sexual partner. Willingness to refuse sperm donation during the period of drug taking and until the end of the follow-up period (completion of the visit Day 100).
Who cannot join
- Chronic disease of cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of gastrointestinal tract, kidneys, blood and autoimmune diseases in the past history.
- Acute infections less than 4 weeks prior to the signing inform consent.
- The presence of documented history of malignant diseases.
- Mental illness and other conditions that may affect the volunteer's ability to follow the study protocol.
- Blood and/or plasma donation in excess of 450 mL within 60 days prior to the signing of informed consent and planned blood and/or plasma donation before the end of the study (completion of the visit Day 100).
- Any prior use of anti-VEGF-antibodies or any other drug targeted at the VEGF receptor, in particular Avastin or its biosimilar.
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- The presence of anaphylaxis in the past history to any biological drug.
- Extensive surgical procedures including appendectomy in the last 12 weeks prior to the signing of the informed consent.
- History of drug or alcohol dependence - regular intake of more than 10 units of alcohol per week (1 unit of alcohol is equal to 500 mL of beer, 200 mL of wine or 50 mL of alcohol).
- Smoking more than 5 cigarettes a day or using an equivalent amount of tobacco, inability to stop smoking during the study.
- The use of any drugs (including drugs based on St John's Wort, with the exception of drugs used as topical application, without systemic absorption) for 14 days or for an interval of time equal to 6 half-life prior to the signing of the informed consent (depending on what time interval is longer); any vaccination within the last 28 days prior to the signing of the informed consent; the use of any biological drug (antibody or its derivative) within 4 months prior to the signing of the informed consent.
- Participation in any clinical trials of medicines less than 90 calendar days prior to the signing of the informed consent.
- Previous participation in the study of drug RPH-001.
- Any volunteer who is an investigator or co-investigator, laboratory assistant, pharmacist, research coordinator or other employee directly involved in the conduct of this study.
- A positive result of any of the following tests: hepatitis B surface antigen (HBs Ag), hepatitis C antibodies (anti-HCV), antibodies to human immunodeficiency virus 1 and 2 (anti-HIV1 and anti-HIV2), blood test for syphilis at the Screening visit.
- Positive urine test result for drugs on Screening visit and visit Day -1 (cannabis, amphetamines, methamphetamine, cocaine, morphine, barbiturates, benzodiazepines).
- Positive test result for alcohol on Screening visit and visit Day -1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Double-blind Randomized Comparative, in Parallel Groups, Clinical Study of Pharmacokinetics and Safety of Drugs RPH-001 (JSC R-Pharm, Russia) and Avastin® (F. Hoffmann-La Roche Ltd, Switzerland) in Single Intravenous Administration in Healthy Volunteers
The purpose of this study is to confirm pharmacokinetic equivalence and compare clinical safety profile of RPH-001 and Avastin®.
Read the detailed description
The study will be conducted in one specialized clinical site in Russia. It is planned to randomize 80 healthy male volunteers in this study. After screening period, not exceeding 15 days, all eligible subjects will be hospitalized to the site and randomized to receive RPH-001 or Avastin in 1:1 ratio. After a single-dose of investigational drugs administration subjects will remain under the observation in clinical site for 8 days and then will be discharged. The out-patient follow up period will include at least 8 scheduled subject's visits to the site. The study will consider completed for each subject at Day 100 visit after all clinical study procedures completion.
- Conditions
- Healthy
- Being tested
- RPH-001, Avastin
- Keywords
- Bevacizumab, oncology, VEGF receptor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RPH-001Biological
Also called Bevacizumab
Concentrate for preparation solution for infusion in ampules, 25 mg/mL
AvastinBiological
Also called Bevacizumab
Concentrate for preparation solution for infusion in ampules, 25 mg/mL
| Study group | Role | What they receive |
|---|---|---|
| RPH-001 | Experimental | Humanized recombinant monoclonal anti-VEGF antibody. 5 mg/kg single intravenous infusion (for no less than 90 minutes) Receives: Biological: RPH-001 |
| Avastin | Active comparator | Humanized recombinant monoclonal anti-VEGF antibody. 5 mg/kg single intravenous infusion (for no less than 90 minutes) Receives: Biological: Avastin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum concentration of investigational drug achieved during sampling
Measured: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion
AUC(0-t)
Area Under the Concentration-time curve from time 0 to the time of the last sample with measurable concentration
Measured: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion
AUC(0-∞)
Area Under the Concentration-time curve from time 0 extrapolated to infinite time
Measured: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion
Secondary outcomes (4)
tmax
Time at which Cmax is attained
Measured: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion
t1/2
The terminal half-life
Measured: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after after the start of investigational product infusion
λz
Elimination rate constant
Measured: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion
Vz
Apparent Volume of Distribution
Measured: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start10 Jul 2018
- Primary completion26 Jan 2019
- Study completion26 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- R-Pharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Almedis
- Responsible party
- Sponsor
- Investigators
- Mikhail Samsonov, Study director, R-Pharm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03659305
- Sponsor's protocol ID
- СL01011063
- Status last verified
- Feb 2019
- First submitted
- 3 Sep 2018
- Last updated
- 5 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Randomized Comparative, in Parallel Groups, Clinical Study of Pharmacokinetics and Safety of Drugs RPH-001 (JSC R-Pharm, Russia) and Avastin® (F. Hoffmann-La Roche Ltd, Switzerland) in Single Intravenous Administration in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03659305
- Acronym / sponsor ID
- СL01011063
- Conditions
- Healthy
- Keywords
- Bevacizumab, oncology, VEGF receptor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- R-PharmIndustry (pharma, biotech, devices)
- Collaborators
- Almedis
- Study start
- 10 Jul 2018 (actual)
- Primary completion
- 26 Jan 2019 (actual)
- Study completion
- 26 Jan 2019 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to confirm pharmacokinetic equivalence and compare clinical safety profile of RPH-001 and Avastin®.
Detailed description
The study will be conducted in one specialized clinical site in Russia. It is planned to randomize 80 healthy male volunteers in this study. After screening period, not exceeding 15 days, all eligible subjects will be hospitalized to the site and randomized to receive RPH-001 or Avastin in 1:1 ratio. After a single-dose of investigational drugs administration subjects will remain under the observation in clinical site for 8 days and then will be discharged. The out-patient follow up period will include at least 8 scheduled subject's visits to the site. The study will consider completed for each subject at Day 100 visit after all clinical study procedures completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RPH-001 | Experimental | Biological: RPH-001Humanized recombinant monoclonal anti-VEGF antibody. 5 mg/kg single intravenous infusion (for no less than 90 minutes) |
| Avastin | Active comparator | Biological: AvastinHumanized recombinant monoclonal anti-VEGF antibody. 5 mg/kg single intravenous infusion (for no less than 90 minutes) |
Who may qualify
- Ages
- 21 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Voluntarily signed informed consent form prior to any research procedure.
- Body Mass Index (BMI) between 18,5 and 30 kg/m^2, inclusively, and body mass between 60 and 100 kg, inclusively.
- Verified diagnosis "Healthy" according to standard clinical, laboratory and instrumental methods of examination, namely haemodynamic parameters within normal limits: systolic blood pressure in the range of 100 - 130 mm Hg inclusive, diastolic blood pressure in the range of 60 - 90 mm Hg inclusive, heart rate is 60-90 beats/minute inclusive (according to the physical examination); the absence of deviations from the norm in the results of laboratory and instrumental methods of examination, including ECG (normal standard electrocardiogram in 12 leads after 10 minutes of rest in the supine position should meet the following parameters: 120ms < PR < 200 ms, QRS<120 ms, QTc ≤ 430 ms).
- The ability of volunteer, according to the investigator, to comply with the Protocol procedures.
- The willingness of the volunteer and his sexual partner with the preserved reproductive function to use reliable methods of contraception from the day of hospitalization (Day -1) until the end of the follow-up period (Day 100). This requirement does not apply to participants who underwent surgical sterilization. Reliable methods of contraception suggest the use of the 1-st barrier method in combination with one of the following: spermicide, intrauterine device/oral contraceptives in the sexual partner. Willingness to refuse sperm donation during the period of drug taking and until the end of the follow-up period (completion of the visit Day 100).
Key exclusion criteria (17 listed)
- Chronic disease of cardiovascular, bronchopulmonary, neuroendocrine systems, as well as diseases of gastrointestinal tract, kidneys, blood and autoimmune diseases in the past history.
- Acute infections less than 4 weeks prior to the signing inform consent.
- The presence of documented history of malignant diseases.
- Mental illness and other conditions that may affect the volunteer's ability to follow the study protocol.
- Blood and/or plasma donation in excess of 450 mL within 60 days prior to the signing of informed consent and planned blood and/or plasma donation before the end of the study (completion of the visit Day 100).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RPH-001Also: BevacizumabConcentrate for preparation solution for infusion in ampules, 25 mg/mL | Biological | RPH-001 |
| AvastinAlso: BevacizumabConcentrate for preparation solution for infusion in ampules, 25 mg/mL | Biological | Avastin |
Primary outcome
Cmax
Time frame: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion
Maximum concentration of investigational drug achieved during sampling
AUC(0-t)
Time frame: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion
Area Under the Concentration-time curve from time 0 to the time of the last sample with measurable concentration
AUC(0-∞)
Time frame: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion
Area Under the Concentration-time curve from time 0 extrapolated to infinite time
4 secondary outcomes
tmax
Time frame: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion
t1/2
Time frame: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after after the start of investigational product infusion
λz
Time frame: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion
Vz
Time frame: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikhail Samsonov study director
R-Pharm
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RPH-001 and Avastin in people with Healthy, run by R-Pharm at 1 site in Russia.
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 5 inclusion and 17 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 5 Feb 2019. 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 Russia. 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?
Cmax (time frame: 30 minutes before and 90 minutes after the start of investigational product infusion, 4, 24, 48, 96, 168, 336, 504, 672, 1008, 1344, 1512,1680 and 2376 hours after the start of investigational product infusion). 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?
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 5 Feb 2019.