Healthy VolunteerPhase 1NCT07416955
Pharmacokinetic, Immunogenicity, and Safety Evaluation of Pegfilgrastim TPI-120 in Healthy Adults
A Phase 1 study testing TPI-120 Pre-Filled Syringe 6 mg/0.6 mL in people with Healthy Volunteer, run by Kashiv BioSciences, LLC at 1 site in United States.
Trial summary
The Goal of these study is to assess the comparative pharmacokinetics of Test Product (A): TPI-120 Injection 6 mg/0.6 mL solution in a single dose pre-filled autoinjector, manufactured by Kashiv Biosciences LLC, USA with Reference Product (B): TPI-120 Injection 6 mg/0.6 mL solution in a single dose pre-filled syringe… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer
- What is being tested?
- TPI-120 Pre-Filled Syringe 6 mg/0.6 mL
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2025to 10 Oct 2025
- 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
- Age: 18 to 55 years of age, both inclusive, at the time of consent.
- Gender: Male and/or non-pregnant, non-lactating female.
- Willing to provide written informed consent to participate in the study.
- Able to communicate effectively with study personnel.
- Subject having weight greater than or equal to 50 kg
- BMI: 19.0 to 30.0 kg/m2, both inclusive
Show all 12Show fewer
- Non-smoker and non-tobacco/non-nicotine user (i.e., having no past history of smoking and tobacco/nicotine consuming for at least one year prior to screening).
- Alcohol breathalyzer test result must be negative during screening and prior to Period 1 dosing.
- Negative urine drug screen including amphetamine/methamphetamine, barbiturates, benzodiazepines, cannabinoid, cocaine, opiates, methadone and phencyclidine during screening and prior to Period 1 dosing.
- The subject has a normal ECG (12 leads) as per the investigator judgement, at screening and on admission day (before admission) of period 1.
- Subject complies with injection site evaluation at screening and on admission day (before admission) of period 1.
- The subject result of hemoglobin is within normal range or ± 5% of medical lab reference range at screening
Who cannot join
- History of antibodies or allergic responses to pegfilgrastim, filgrastim or other GCSF stimulant medications or other related drugs, or any of its formulation ingredients.
- Any infection, cough or fever or suffered an acute illness within 1 week prior to first study drug administration.
- Subject having hematologic laboratory abnormalities
- The subject has been hospitalized within three months before the study or during the study
- The subject has been participating in any clinical study (e.g., pharmacokinetics, bioavailability and bioequivalence studies) within the last 30 days prior to the present study
- Clinically significant vital sign abnormalities
Show all 12Show fewer
- Positive hepatitis screen (includes subtypes B \& C) and/or a positive test result for HIV antibody.
- Study participants who have received a known investigational drug within 30 days or within seven elimination half-lives of the administered drug prior to the initial dose of study drug, whichever is greater.
- Study participant who has donated blood and/or had a blood loss of approximately 1 unit or 450 mL within 90 days prior to the initial dosing of the study drug and/or study participant who had blood loss, excluding volume drawn at screening for this study, prior to initial dosing of study drug, whichever is greater
- Study participant who has a condition or is taking or has taken a medication that, in the Investigator's judgment, makes the study participant ineligible or places the study participant at undue risk
- Any food allergy, intolerance, restriction or special diet that, in the opinion of the principal investigator or sub-investigator, could contraindicate the study participant's participation in this study.
- Unavailable for any confinement days or scheduled visits.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Two-treatment, Two Sequence, Two Period, Crossover, Single Dose, Comparative Pharmacokinetic, Immunogenicity and Safety Study of Pegfilgrastim Comparing TPI-120 Pre-Filled Syringe With Auto- Injector 6 mg/0.6 mL (T) and Fylnetra Pre-filled Syringe 6 mg/0.6 mL (R) Administered Through Subcutaneous Route, in Normal, Healthy, Adult Human Subjects Under Fasting Conditions
The Goal of these study is to assess the comparative pharmacokinetics of Test Product (A): TPI-120 Injection 6 mg/0.6 mL solution in a single dose pre-filled autoinjector, manufactured by Kashiv Biosciences LLC, USA with Reference Product (B): TPI-120 Injection 6 mg/0.6 mL solution in a single dose pre-filled syringe manufactured by Kashiv Biosciences LLC, USA in healthy, adult human subjects and also to assess safety and tolerability of investigational product.
Read the detailed description
This study is an open label, randomized, two treatment, two sequence, two period, single dose crossover clinical trial designed to compare the pharmacokinetics, immunogenicity, and safety of Pegfilgrastim TPI 120 (Test) administered via pre filled syringe with auto injector and Fylnetra (Reference) administered via pre filled syringe. The study will be conducted in healthy adult human subjects under fasting conditions.
The study aims to enroll a sufficient number of participants to ensure that 180 healthy subjects complete dosing across both periods. Considering the required procedures and a washout period of at least 34 days between the dosing days of Period I and Period II, the total clinical study duration is approximately 51 days from the first check in. Subjects will be randomized into two treatment sequences and will receive a single subcutaneous dose of either the Test or Reference product in each study period.
The primary objective is to assess the pharmacokinetic (PK) comparability of the two Pegfilgrastim formulations by evaluating PK parameters including Cmax, AUCt, AUCi, Tmax, Kel, AUC%Extrap_obs, and tHalf. PK parameters will be calculated using Phoenix® WinNonlin® (Version 8.1.1 or higher) or SAS® (Version 9.4 or higher). Secondary objectives include assessment of safety and tolerability, as well as immunogenicity through anti drug antibody (ADA) evaluations.
Comprehensive safety assessments will be performed throughout the study. A complete physical examination will be conducted at screening and at the end of the study or early termination, while abbreviated physical examinations will occur during admission of each period, on Day 15 of Period I, and prior to discharge in each period. Clinical laboratory evaluations will include hematology, including absolute neutrophil count (ANC), coagulation (PT/INR), clinical chemistry, and urinalysis, performed at defined time points: screening, check in of Period 1, two days prior to Period 2 check in, Day 15 of Period I, and end of study or early termination.
A 12 lead ECG will be performed at screening, on Day 15 of Period I post dose, and at the end of the study or early termination. Safety screening also includes urine drug screens for drugs of abuse (amphetamine/methamphetamine, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, methadone, and phencyclidine) and alcohol breathalyzer testing at screening and prior to admission of each study period.
Subjects will be closely monitored for adverse events (AEs), serious adverse events (SAEs), changes in laboratory parameters, vital signs, and any clinically significant abnormalities. Immunogenicity evaluations will be performed at protocol specified time points to assess the presence of ADAs and potential neutralizing antibodies.
This study is designed to generate robust comparative PK, safety, and immunogenicity data to support the evaluation of biosimilar comparability between Pegfilgrastim TPI 120 and Fylnetra under fasting conditions in healthy adult subjects.
- Conditions
- Healthy Volunteer
- Being tested
- TPI-120 Pre-Filled Syringe 6 mg/0.6 mL
- Keywords
- Pegfilgrastim
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPI-120 Pre-Filled Syringe 6 mg/0.6 mLBiological
TPI-120 Pre-Filled Syringe 6 mg/0.6 mL with auto injector - Manufactured/supplied by: Kashiv Biosciences LLC, USA
| Study group | Role | What they receive |
|---|---|---|
| TPI-120 Pre-Filled Syringe 6 mg/0.6 mL with auto injector | Experimental | Intervention Group Receives: Biological: TPI-120 Pre-Filled Syringe 6 mg/0.6 mL |
| Fylnetra Pre-Filled Syringe 6 mg/0.6 mL | Active comparator | Comparator Group Receives: Biological: TPI-120 Pre-Filled Syringe 6 mg/0.6 mL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameter
Cmax,
Measured: Baseline to Day 15
Pharmacokinetic parameter
AUCt
Measured: Time Frame: Baseline to Day 15
Pharmacokinetic parameter
AUC0-inf
Measured: Time Frame: Baseline to Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start5 Apr 2025
- Primary completion10 Oct 2025
- Study completion10 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kashiv BioSciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cliantha Research
- Responsible party
- Sponsor
- Investigators
- Tamatha F Zemzars, MD, Principal investigator, Cliantha Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07416955
- Sponsor's protocol ID
- C1C04946
- Status last verified
- Feb 2026
- First submitted
- 6 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Two-treatment, Two Sequence, Two Period, Crossover, Single Dose, Comparative Pharmacokinetic, Immunogenicity and Safety Study of Pegfilgrastim Comparing TPI-120 Pre-Filled Syringe With Auto- Injector 6 mg/0.6 mL (T) and Fylnetra Pre-filled Syringe 6 mg/0.6 mL (R) Administered Through Subcutaneous Route, in Normal, Healthy, Adult Human Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT07416955
- Acronym / sponsor ID
- C1C04946
- Conditions
- Healthy Volunteer
- Keywords
- Pegfilgrastim
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Kashiv BioSciences, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Cliantha Research
- Study start
- 5 Apr 2025 (actual)
- Primary completion
- 10 Oct 2025 (actual)
- Study completion
- 10 Oct 2025 (actual)
- First posted
- 18 Feb 2026 (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 Goal of these study is to assess the comparative pharmacokinetics of Test Product (A): TPI-120 Injection 6 mg/0.6 mL solution in a single dose pre-filled autoinjector, manufactured by Kashiv Biosciences LLC, USA with Reference Product (B): TPI-120 Injection 6 mg/0.6 mL solution in a single dose pre-filled syringe manufactured by Kashiv Biosciences LLC, USA in healthy, adult human subjects and also to assess safety and tolerability of investigational product.
Detailed description
This study is an open label, randomized, two treatment, two sequence, two period, single dose crossover clinical trial designed to compare the pharmacokinetics, immunogenicity, and safety of Pegfilgrastim TPI 120 (Test) administered via pre filled syringe with auto injector and Fylnetra (Reference) administered via pre filled syringe. The study will be conducted in healthy adult human subjects under fasting conditions.
The study aims to enroll a sufficient number of participants to ensure that 180 healthy subjects complete dosing across both periods. Considering the required procedures and a washout period of at least 34 days between the dosing days of Period I and Period II, the total clinical study duration is approximately 51 days from the first check in. Subjects will be randomized into two treatment sequences and will receive a single subcutaneous dose of either the Test or Reference product in each study period.
The primary objective is to assess the pharmacokinetic (PK) comparability of the two Pegfilgrastim formulations by evaluating PK parameters including Cmax, AUCt, AUCi, Tmax, Kel, AUC%Extrap_obs, and tHalf. PK parameters will be calculated using Phoenix® WinNonlin® (Version 8.1.1 or higher) or SAS® (Version 9.4 or higher). Secondary objectives include assessment of safety and tolerability, as well as immunogenicity through anti drug antibody (ADA) evaluations.
Comprehensive safety assessments will be performed throughout the study. A complete physical examination will be conducted at screening and at the end of the study or early termination, while abbreviated physical examinations will occur during admission of each period, on Day 15 of Period I, and prior to discharge in each period. Clinical laboratory evaluations will include hematology, including absolute neutrophil count (ANC), coagulation (PT/INR), clinical chemistry, and urinalysis, performed at defined time points: screening, check in of Period 1, two days prior to Period 2 check in, Day 15 of Period I, and end of study or early termination.
A 12 lead ECG will be performed at screening, on Day 15 of Period I post dose, and at the end of the study or early termination. Safety screening also includes urine drug screens for drugs of abuse (amphetamine/methamphetamine, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates, methadone, and phencyclidine) and alcohol breathalyzer testing at screening and prior to admission of each study period.
Subjects will be closely monitored for adverse events (AEs), serious adverse events (SAEs), changes in laboratory parameters, vital signs, and any clinically significant abnormalities. Immunogenicity evaluations will be performed at protocol specified time points to assess the presence of ADAs and potential neutralizing antibodies.
This study is designed to generate robust comparative PK, safety, and immunogenicity data to support the evaluation of biosimilar comparability between Pegfilgrastim TPI 120 and Fylnetra under fasting conditions in healthy adult subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TPI-120 Pre-Filled Syringe 6 mg/0.6 mL with auto injector | Experimental | Biological: TPI-120 Pre-Filled Syringe 6 mg/0.6 mLIntervention Group |
| Fylnetra Pre-Filled Syringe 6 mg/0.6 mL | Active comparator | Biological: TPI-120 Pre-Filled Syringe 6 mg/0.6 mLComparator Group |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Age: 18 to 55 years of age, both inclusive, at the time of consent.
- Gender: Male and/or non-pregnant, non-lactating female.
- Willing to provide written informed consent to participate in the study.
- Able to communicate effectively with study personnel.
- Subject having weight greater than or equal to 50 kg
Key exclusion criteria (12 listed)
- History of antibodies or allergic responses to pegfilgrastim, filgrastim or other GCSF stimulant medications or other related drugs, or any of its formulation ingredients.
- Any infection, cough or fever or suffered an acute illness within 1 week prior to first study drug administration.
- Subject having hematologic laboratory abnormalities
- The subject has been hospitalized within three months before the study or during the study
- The subject has been participating in any clinical study (e.g., pharmacokinetics, bioavailability and bioequivalence studies) within the last 30 days prior to the present study
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 |
|---|---|---|
| TPI-120 Pre-Filled Syringe 6 mg/0.6 mLTPI-120 Pre-Filled Syringe 6 mg/0.6 mL with auto injector - Manufactured/supplied by: Kashiv Biosciences LLC, USA | Biological | Fylnetra Pre-Filled Syringe 6 mg/0.6 mL, TPI-120 Pre-Filled Syringe 6 mg/0.6 mL with auto injector |
Primary outcome
Pharmacokinetic parameter
Time frame: Baseline to Day 15
Cmax,
Pharmacokinetic parameter
Time frame: Time Frame: Baseline to Day 15
AUCt
Pharmacokinetic parameter
Time frame: Time Frame: Baseline to Day 15
AUC0-inf
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 18 Feb 2026.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteer
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Not yet recruitingObservational study
Establishment of Biobank of Nasal Epithelium Samples From Healthy Volunteers
Healthy
RecruitingObservational study
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
Graft-Versus-Host Disease, Graft-versus-leukemia
Not yet recruitingObservational study
Screening Protocol
Pain
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.
Tamatha F Zemzars, MD principal investigator
Cliantha Research
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 TPI-120 Pre-Filled Syringe 6 mg/0.6 mL in people with Healthy Volunteer, run by Kashiv BioSciences, LLC at 1 site in United States.
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 12 inclusion and 12 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 18 Feb 2026. 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 States. 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 (time frame: Baseline to Day 15). 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 18 Feb 2026.