BioequivalencePhase 1NCT03146988
Study to Compare the Pharmacokinetics and Pharmacodynamics of 6 mg RGB-02 to 6 mg Neulasta
A Phase 1 study testing RGB-02 or Neulasta® (pegfilgrastim) in people with Bioequivalence, run by Gedeon Richter Plc. at 1 site in United Kingdom.
Trial summary
Single-centre, double-blind, randomised, two-period, two-way crossover study to investigate the pharmacokinetics and pharmacodynamics of RGB-02 as compared to Neulasta® administered as a single subcutaneous injection in healthy adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- RGB-02 or Neulasta® (pegfilgrastim)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Apr 2017to 4 Oct 2017
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males or non-pregnant, non-lactating healthy females aged 18 to 55 years
- Body mass index ≥19.0 to ≤30.0 kg/m2
- Body weight >55 kg"
Who cannot join
- Prior exposure to filgrastim, pegfilgrastim or lenograstim (Period 1 only)
- Subjects who have received any IMP in a clinical research study within the previous 3 months
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Current smokers who smoke more than 10 cigarettes per day
- Positive drugs of abuse test result
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Clinical
Ruddington, Nottingham, NG11 6JS
About this study
Official title: Randomised, Double-Blind, Single, 6 mg Fixed Dose, Two Treatment, Two-Period, Two-Sequence, Two-Way Crossover Comparative Pharmacokinetic and Pharmacodynamic (Phase I) Study of RGB-02 Compared to Neulasta® in Healthy Adult Subjects
Single-centre, double-blind, randomised, two-period, two-way crossover study to investigate the pharmacokinetics and pharmacodynamics of RGB-02 as compared to Neulasta® administered as a single subcutaneous injection in healthy adult subjects.
- Conditions
- Bioequivalence
- Being tested
- RGB-02 or Neulasta® (pegfilgrastim)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RGB-02 or Neulasta® (pegfilgrastim)Drug
Pre-filled syringe containing 6 mg RGB-02 or Neulasta® in 0.6 mL, administered as subcutaneous injection into the abdominal area
| Study group | Role | What they receive |
|---|---|---|
| RGB-02 6 mg SC (test product) | Experimental | Not described Receives: Drug: RGB-02 or Neulasta® (pegfilgrastim) |
| Neulasta® | Active comparator | Not described Receives: Drug: RGB-02 or Neulasta® (pegfilgrastim) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter: AUC0-inf
Area under the serum concentration vs time curve from dosing to the last measured time point
Measured: 67 days
Pharmacokinetic parameter: Cmax
Measured: 67 days
Pharmacodynamic parameter: ANCmax
Measured: 67 days
Pharmacodynamic parameter: ANC AOBEC0-tlast
Measured: 67 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start10 Apr 2017
- Primary completion14 Sep 2017
- Study completion4 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gedeon Richter Plc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03146988
- Sponsor's protocol ID
- RGB-02-001
- Status last verified
- Nov 2017
- First submitted
- 26 Apr 2017
- Last updated
- 22 Nov 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-Blind, Single, 6 mg Fixed Dose, Two Treatment, Two-Period, Two-Sequence, Two-Way Crossover Comparative Pharmacokinetic and Pharmacodynamic (Phase I) Study of RGB-02 Compared to Neulasta® in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03146988
- Acronym / sponsor ID
- RGB-02-001
- Conditions
- Bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Gedeon Richter Plc.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2017 (actual)
- Primary completion
- 14 Sep 2017 (actual)
- Study completion
- 4 Oct 2017 (actual)
- First posted
- 10 May 2017 (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.
Single-centre, double-blind, randomised, two-period, two-way crossover study to investigate the pharmacokinetics and pharmacodynamics of RGB-02 as compared to Neulasta® administered as a single subcutaneous injection in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RGB-02 6 mg SC (test product) | Experimental | Drug: RGB-02 or Neulasta® (pegfilgrastim) |
| Neulasta® | Active comparator | Drug: RGB-02 or Neulasta® (pegfilgrastim) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males or non-pregnant, non-lactating healthy females aged 18 to 55 years
- Body mass index ≥19.0 to ≤30.0 kg/m2
- Body weight >55 kg"
Key exclusion criteria (7 listed)
- Prior exposure to filgrastim, pegfilgrastim or lenograstim (Period 1 only)
- Subjects who have received any IMP in a clinical research study within the previous 3 months
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Current smokers who smoke more than 10 cigarettes per day
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 |
|---|---|---|
| RGB-02 or Neulasta® (pegfilgrastim)Pre-filled syringe containing 6 mg RGB-02 or Neulasta® in 0.6 mL, administered as subcutaneous injection into the abdominal area | Drug | Neulasta®, RGB-02 6 mg SC (test product) |
Primary outcome
Pharmacokinetic parameter: AUC0-inf
Time frame: 67 days
Area under the serum concentration vs time curve from dosing to the last measured time point
Pharmacokinetic parameter: Cmax
Time frame: 67 days
Pharmacodynamic parameter: ANCmax
Time frame: 67 days
Pharmacodynamic parameter: ANC AOBEC0-tlast
Time frame: 67 days
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 22 Nov 2017.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 RGB-02 or Neulasta® (pegfilgrastim) in people with Bioequivalence, run by Gedeon Richter Plc. at 1 site in United Kingdom.
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 3 inclusion and 7 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 22 Nov 2017. 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 United Kingdom. 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?
Pharmacokinetic parameter: AUC0-inf (time frame: 67 days). The study lists 4 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 22 Nov 2017.