NeutropeniaPhase 1NCT04873765
Biosimilarity Study of Subcutaneous Pegfilgrastim in Healthy Volunteers
A Phase 1 study testing Pegfilgastrim Megalabs and Pegfilgastim Amgen in people with Neutropenia, run by Megalabs at 1 site in Uruguay.
Trial summary
This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between pegfilgrastim formulation, produced by Megalabs (test product) and Neulastim® (reference product) Amgen. 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
- Neutropenia
- What is being tested?
- Pegfilgastrim Megalabs and Pegfilgastim Amgen
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUruguay
- Study dates
- 18 Mar 2022to 18 Sep 2022
- 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 eligible participants able to read, understand and sign the latest version of the Informed Consent Form (ICF) approved by the Research Ethics Committee (CEP)
- Males aged between 18 and 55 years
- Be characterized as a healthy research participant, based on medical history general physical examination and vital signs, laboratory tests and electrocardiogram (ECG),
- Not indicating any evidence of disease
- Body weight between 60-100 kg;
- Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 Kg / m2;
- Negative test for coronavirus
Who cannot join
- Present one or more flu-like symptoms such as: fever (body temperature greater than or equal to 37.8 ° C), cough, dyspnoea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 7 days prior to the hospitalization period (all periods);
- Direct and significant medical contact with people who tested positive for coronavirus testing within 14 days prior to the hospitalization period (all periods);
- Living in the same household as people who are in the risk group with the worst prognosis for coronavirus infection, such as individuals over 60, individuals with respiratory problems, immunosuppressed or those with chronic diseases, such as heart or diabetes (all periods).
- Participants diagnosed with malignant disease in the last 5 years, with the exception of successfully treated basal cell carcinoma;
- Participants with a previous diagnosis of severe asthma, sickle cell anemia, idiopathic urticaria or anaphylaxis;
- Participants with chronic diseases and, therefore, who regularly use medications;
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- Being a smoker or quitting less than 6 months ago;
- Participants who consume more than 5 cups of tea or coffee a day and who cannot abstain during the trial period;
- History of alcohol and illicit drug abuse
- Electrocardiogram (ECG) findings that, at the investigator's discretion, may compromise participation in the trial;
- History or presence of gastrointestinal or liver diseases or any other condition that interferes with the absorption, distribution, excretion or metabolism of the drug;
- Use of lithium 2 weeks before and / or after medication administration;
- Participants who are hypersensitive or contraindicated to use any of the components of the formulation;
- Research participants who have participated in clinical trial protocols in the last 12 (twelve) months (Resolution CNS 251, of August 7, 1997, item III, subitem J);
- Have donated blood (> 500 mL) or have undergone major surgery in the 3 (three) months preceding the date of signing the informed consent form;
- Have received any vaccine in the 3 (three) months preceding the date of signing the informed consent form;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Clinical Trial With Pharmacokinetic and Pharmacodynamic Determination of Subcutaneous Pegfilgrastim in Healthy Subjects
This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between pegfilgrastim formulation, produced by Megalabs (test product) and Neulastim® (reference product) Amgen.
- Conditions
- Neutropenia
- Being tested
- Pegfilgastrim Megalabs, Pegfilgastim Amgen
- Medical subject headings
- Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegfilgastrim MegalabsBiological
Administration of 6 mg of Pegfilgrastim Megalabs subcutaneous single dose
Pegfilgastim AmgenBiological
Administration of 6 mg of Pegfilgrastim Amgen subcutaneous single dose
| Study group | Role | What they receive |
|---|---|---|
| Pegfilgrastim Megalabs | Experimental | Pegfilgrastim injectable 6 mg in a single subcutaneous application. Receives: Biological: Pegfilgastrim Megalabs; Biological: Pegfilgastim Amgen |
| Pegfilgastrim Neulastim | Active comparator | Neulastim injectable 6 mg in a single subcutaneous application. Receives: Biological: Pegfilgastrim Megalabs; Biological: Pegfilgastim Amgen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Cmax in healthy volunteers for test and reference
Measured: 16 days
Evaluation of AUC 0-t of pegfilgrastim in healthy volunteers for test and reference
Measured: 16 days
Evaluation of absolute neutrophil count (ANC) in healthy volunteers for test and reference
Measured: 16 days
Secondary outcomes (1)
Evaluation of CD34+ count for test and reference
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start18 Mar 2022
- Primary completion18 Aug 2022
- Study completion18 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeutropeniaStudies 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
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Megalabs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- José Pedrazzoli Junior, MD, Principal investigator, Unidade Integrada de Farmacologia e Gastroenterologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04873765
- Sponsor's protocol ID
- GIGA
- Status last verified
- Aug 2024
- First submitted
- 25 Apr 2021
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial With Pharmacokinetic and Pharmacodynamic Determination of Subcutaneous Pegfilgrastim in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04873765
- Acronym / sponsor ID
- GIGA
- Conditions
- Neutropenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- MegalabsIndustry (pharma, biotech, devices)
- Study start
- 18 Mar 2022 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 18 Sep 2022 (actual)
- First posted
- 5 May 2021 (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.
This study will compare the pharmacokinetics and pharmacodynamics, after single subcutaneous application, in healthy men, between pegfilgrastim formulation, produced by Megalabs (test product) and Neulastim® (reference product) Amgen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pegfilgrastim Megalabs | Experimental | Biological: Pegfilgastrim Megalabs, Biological: Pegfilgastim AmgenPegfilgrastim injectable 6 mg in a single subcutaneous application. |
| Pegfilgastrim Neulastim | Active comparator | Biological: Pegfilgastrim Megalabs, Biological: Pegfilgastim AmgenNeulastim injectable 6 mg in a single subcutaneous application. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy eligible participants able to read, understand and sign the latest version of the Informed Consent Form (ICF) approved by the Research Ethics Committee (CEP)
- Males aged between 18 and 55 years
- Be characterized as a healthy research participant, based on medical history general physical examination and vital signs, laboratory tests and electrocardiogram (ECG),
- Not indicating any evidence of disease
- Body weight between 60-100 kg;
Key exclusion criteria (16 listed)
- Present one or more flu-like symptoms such as: fever (body temperature greater than or equal to 37.8 ° C), cough, dyspnoea, myalgia and fatigue, respiratory symptoms, gastrointestinal symptoms (such as diarrhea) within 7 days prior to the hospitalization period (all periods);
- Direct and significant medical contact with people who tested positive for coronavirus testing within 14 days prior to the hospitalization period (all periods);
- Living in the same household as people who are in the risk group with the worst prognosis for coronavirus infection, such as individuals over 60, individuals with respiratory problems, immunosuppressed or those with chronic diseases, such as heart or diabetes (all periods).
- Participants diagnosed with malignant disease in the last 5 years, with the exception of successfully treated basal cell carcinoma;
- Participants with a previous diagnosis of severe asthma, sickle cell anemia, idiopathic urticaria or anaphylaxis;
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 |
|---|---|---|
| Pegfilgastrim MegalabsAdministration of 6 mg of Pegfilgrastim Megalabs subcutaneous single dose | Biological | Pegfilgastrim Neulastim, Pegfilgrastim Megalabs |
| Pegfilgastim AmgenAdministration of 6 mg of Pegfilgrastim Amgen subcutaneous single dose | Biological | Pegfilgastrim Neulastim, Pegfilgrastim Megalabs |
Primary outcome
Evaluation of Cmax in healthy volunteers for test and reference
Time frame: 16 days
Evaluation of AUC 0-t of pegfilgrastim in healthy volunteers for test and reference
Time frame: 16 days
Evaluation of absolute neutrophil count (ANC) in healthy volunteers for test and reference
Time frame: 16 days
1 secondary outcome
Evaluation of CD34+ count for test and reference
Time frame: 6 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 16 Aug 2024.
- Individual participant dataSharing planned: No
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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.
José Pedrazzoli Junior, MD principal investigator
Unidade Integrada de Farmacologia e Gastroenterologia
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 Pegfilgastrim Megalabs and Pegfilgastim Amgen in people with Neutropenia, run by Megalabs at 1 site in Uruguay.
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 7 inclusion and 16 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 16 Aug 2024. 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 Uruguay. 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?
Evaluation of Cmax in healthy volunteers for test and reference (time frame: 16 days). 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 16 Aug 2024.