Febrile NeutropeniaPhase 1NCT06918587
A Comparative Evaluation of Pharmacokinetics and Immunogenicity.
A Phase 1 study testing TPI-120 with On body injector and Fylntera in people with Febrile Neutropenia, run by Kashiv BioSciences, LLC at 1 site in Jordan.
Trial summary
The Goal of these study is to evaluate and To compare the pharmacokinetics (PK) of the Test product (T) getting administered through prefilled syringe with on-body injector with Reference product as prefilled syringe following a single 6 mg dose administered through subcutaneous route in healthy adult Human subjects. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Febrile Neutropenia
- What is being tested?
- TPI-120 with On body injector and Fylntera
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteJordan
- Study dates
- 5 Sep 2024to 25 May 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects are physically and mentally healthy adults aged between 18 and 50 years (both inclusive) at screening.
- Subject's weight within normal range according to normal values for Body Mass Index (18.5 to 30.0 kg/m2) (both inclusive) with minimum of 50 kg weight at screening.
- The findings of the subject are within the range of clinical acceptability in medical history, medication history, clinical examination, and laboratory examinations "other than RBC indices (MCH, MCV and MCHC) and hemoglobin" are within "normal ranges" or abnormalities considered insignificant and justified by the principal/clinical sub- Investigator at screening.
- The subject results of all RBC indices (MCH, MCV and MCHC) and hemoglobin are within normal range or ± 5% of medical lab reference range at screening.
- The subject's kidney function tests (Serum Creatinine, Potassium, Sodium) are within the medical lab reference range, and kidney function tests (urea, and chloride) are considered clinically acceptable as per the investigator judgment at screening. If creatinine is below the lower normal limit while the other parameters are normal, it will be considered as clinically not significant unless otherwise judged by the investigator.
- The subject's Liver function tests (AST, ALT, GGT, and total bilirubin) results are within the medical lab reference ranges and liver function tests (Alkaline phosphatase, total protein, and albumin) are considered clinically acceptable as per PI / SI judgment at screening.
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- 7.The subject's Cholesterol level is considered clinically acceptable as per PI / SI judgment at screening.
- 8.The subject is fasting for at least 12 hrs before giving the samples required for clinical laboratory examinations as checked at screening .
- 9.Subject having vital signs parameters (blood pressure, body temperature, pulse rate and respiratory rate) are within the following ranges at screening, and on admission day (before admission) of period I: Blood Pressure: Systolic: (90- 140) mmHg, Diastolic: (60-90) mmHg Body Temperature: (36.1 - 37.2) ºC Pulse rate: 60 to 100 beat per minute. Respiratory rate: 12-18 bpm. 10.Subject complies with Injection site evaluation at screening and on admission day (before admission) of period I.
- 11.The subject has a normal ECG (12 leads) as per the investigator judgement, at screening and on admission day (before admission) of period I.
- 12.The subject has normal abdominal ultrasonography (no signs of spleen rupture or splenomegaly) as checked at screening 13.The subject has clinically acceptable chest x-ray (PA view) as per the investigator judgment as checked at screening.
- 14.The subject has having negative urine screen for drugs of abuse (amphetamine, barbiturates, benzodiazepines, cocaine, opiates, marijuana, methadone, methamphetamine, phencyclidine, and Tricyclic antidepressants) at screening and on admission day (before admission) of period I .
- 15.The subject has negative alcohol test at screening and on admission day (before admission) of period I.
- 16.The subject (available for entire study duration) is willing to adhere to the protocol requirements and to provide signed informed consent (by applying his / her signature or fingerprint) as confirmed at screening and on admission day (before admission) of period I.
- Females of non-childbearing potential must have undergone sterilization procedures, at least 6 months prior to the first dose or be postmenopausal with amenorrhea for at least 1 year prior to the first dose and follicle-stimulating hormone (FSH) serum levels consistent with postmenopausal status 18.For Female Subjects "who have the potential to become pregnant":
- •The subject has negative serum pregnancy test at screening and on admission day (before admission) of period I.
- Female of child bearing potential agrees to practice for the duration of the study an acceptable method of birth control as judged by the investigator(s), such as intrauterine device (IUD), abstinence or double barrier contraception, i.e., condom + diaphragm, condom + spermicidal or foam prior to the start of the study and through the study and for 30 days after last dosing in study as checked at screening and on admission day (before admission) of period I.
- 19.The male subject agrees, at screening and on admission day (before admission) of period I, to use a condom for the duration of the study, and for 30 days after last dosing in study if: He is engaged in sexual activity with a woman of childbearing potential.
- A condom is required along with another medically acceptable contraceptive method. Medically acceptable methods of contraception include non-hormonal intrauterine device or double barrier method (condom with foam or vaginal spermicidal suppository, diaphragm with spermicide).
- Not to donate sperms during the study and for 30 days after last dosing in study
Who cannot join
- Subjects will be excluded from the study, if they meet any one of the following criteria:
- The subject has history of allergy or hypersensitivity to study drug or adhesive material or related class of drugs or to the inactive ingredients (acetate/acetic acid, polysorbate 20, or sorbitol) of the test and reference formulation as checked at screening.
- The subject has history or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological disease, or disorder as checked at screening or on admission day (before admission) of period I.
- The subject has an evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of the consent to participation in the study or limit the ability to comply with the protocol requirements, as determined by the principal investigator/clinical sub-investigator at screening or on admission day (before admission) of period I.
- The subject has a clinically significant history of skin disorders, including psoriasis or any clinically significant skin abnormality at injection site as checked at screening or on admission day (before admission) of period I.
- The subject has a history of any of the following, as checked at screening: Autoimmune disease.
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- Splenic Rupture or Splenomegaly. Acute respiratory distress syndrome Sickle Cell Disorders Glomerulonephritis Leukocytosis Thrombocytopenia Capillary Leak Syndrome History of cancer; or malignant Cells. Aortitis History of pulmonary infiltrate or pneumonia (radiologically confirmed) within 6 months prior to initial dosing.
- Any past exposure to recombinant human G-CSF products and/or a known history of prior treatment with blood-cell colony stimulating factors, interleukins or interferons.
- History or presence of asthma, urticaria or other significant allergic reactions as checked at screening.
- 7.History or presence of significant gastric and/or duodenal ulceration as checked at screening.
- 8.The subject has received any vaccination (including influenza) within 60 days prior to first dosing as checked at screening.
- 9.The subject used any treatment which could bring about induction or inhibition of hepatic microsomal enzyme system within 1 month prior to dosing of Period I as checked at screening or on admission day (before admission) of period I.
- 10.The subject is a moderate smoker (more than 10 cigarettes per day) as checked at screening or on admission day (before admission) of period I 11.History or presence of drug abuse in the past one year as checked at screening.
- 12.History or presence of alcohol abuse in the past one year [alcohol abuse will be >14 drinks per week (1 drink = 360 mL beer, 150 mL wine, or 45 mL hard liquor)] as checked at screening.
- 13.Difficulty with donating blood as checked at screening or on admission day (before admission) of period I.
- 14.Use of any prescribed medication or OTC medication including vitamins and herbal remedies during last 14 days prior to dosing in period I as checked at screening or on admission day (before admission) of period I.
- 15.Major illness or hospitalization within past 3 months as checked at screening or on admission day (before admission) of period I.
- 16.Volunteer/s who have donated 1 unit blood (≥ 300 mL) or participated in a clinical study involving blood sampling within 80 days prior to the first dose of the study drug as checked at screening or on admission day (before admission) of period I.
- 17.Consumption of grapefruit juice, caffeine, poppy seeds, within 72 hours prior to dosing and other xanthine-containing products, tobacco containing products or any alcoholic products within 48 hours prior to dosing as checked on admission day (before admission) of period I .
- 18.Positive test for one or more: HIV, Hepatitis B and Hepatitis C at screening.
- 19.History or presence of significant easy bruising or bleeding as checked at screening.
- History or presence of significant recent trauma as checked at screening. 21.Female volunteer who has used implanted or injected hormonal contraceptives anytime during the 6 months prior to study or used hormonal contraceptives within 14 days before dosing as checked at screening or on admission day (before admission) of period I.
- 22.Female subjects who are currently breast feeding as checked at screening or on admission day (before admission) of period I.
- 23.Pregnant female volunteers as checked at screening or on admission day (before admission) of period I.
- 24.Known allergies to acrylics (as the on-body injector uses acrylic adhesive) as checked at screening or on admission day (before admission) of period I.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Randomized, Balanced, Two-treatment, Single Period, Parallel, Single Dose, Subcutaneous Administration, Comparative Pharmacokinetic Study Under Fasting Conditions.
The Goal of these study is to evaluate and To compare the pharmacokinetics (PK) of the Test product (T) getting administered through prefilled syringe with on-body injector with Reference product as prefilled syringe following a single 6 mg dose administered through subcutaneous route in healthy adult Human subjects.
Subjects safety and immunogenicity will also be evaluated during these study as follows Safety - monitoring the adverse events , vitals signs, ECG, laboratory parameters, and injection site assessment.
Immunogenicity assessment- detection of ADA (Anti-PEG antibody levels ) and Nab (Neutralizing antibodies) will be done pre-dose and post dose on day 15 of each period.
Read the detailed description
An Open label, randomized, single-dose, two sequences, two-period crossover comparative Pharmacokinetic, immunogenicity and safety study under fasting conditions. Duration of the clinical phase will be approximately 51 days starting from admission of period I until giving the last sample in period II.
A washout period of at least 34 days will be kept between dosing day in period I and dosing day period II.
Approximate volume of blood loss in the study will be 309 mL for both male and female's subjects. A total of Twenty-two (22) blood samples for PK parameters will be collected in SST tubes in each study period. Blood samples (5.0 mL) will be collected at pre-dose (00.00 hr) in the morning of dosing day (day 1) within 01.00 hour prior to dosing and at 00.33, 00.50, 00.75, 01.00, 02.00, 04.00, 06.00, 08.00, 10.00, 12.00,14.00, 16.00, 20.00, 24.00 (day 2), 36.00, 48.00 (day 3), 72.00 (day 4), 120.00 (day 6), 192.00 (day 9), 264.00 (day 12), 336.00 (day 15) hours post-dose during each study period.
Immunogenicity samples for ADA detection (anti-PEG- antibody) and Nab (Neutralizing antibodies) will be collected at pre- dose, and on day 15 (4.0 mL for each sampling time/ test) during each study period, into SST tubes.
Summary Statistics will be calculated for Pegfilgrastim pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf, Tmax, t12, Kel and AUC Extrapolated. Statistical tests like ANOVA, least square means for test and reference products, Two One- Sided Tests for 90% confidence interval limits and power will be calculated for In-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf Geometric least square means of test and reference products, it's ratio, 90% confidence interval for geometric least square means ratio and intra-subject variability will be calculated for pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf for Pegfilgrastim.
Dose normalization for Cmax, AUC0-t and AUC0-inf will be done considering the actual administered dose for each subject (based on the difference in PFS/OBI/AI weight before and after dosing). This is an additional PK analysis dataset.
- Conditions
- Febrile Neutropenia
- Being tested
- TPI-120 with On body injector, Fylntera
- Keywords
- pegfilgratim, on body injector
- Medical subject headings
- Febrile Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPI-120 with On body injectorDevice
TPI-120 pre-filled syringe 6 mg co-packaged with on-body injector, manufactured by: Kashiv Biosciences LLC, USA.
FylnteraDrug
Fylnetra Pre-Filled Syringe 6 mg, manufactured by: Kashiv Biosciences LLC, USA.
| Study group | Role | What they receive |
|---|---|---|
| Test Product TPI-120 with On body Injector 6 mg | Experimental | TPI-120 pre-filled syringe 6 mg co-packaged with on body injector, manufactured by: Kashiv Biosciences LLC, USA. Receives: Device: TPI-120 with On body injector |
| Fylnetra | Active comparator | Fylnetra Pre-Filled Syringe 6 mg, manufactured by:
Kashiv Biosciences LLC, USA. Receives: Drug: Fylntera |
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
AUC0-t
Measured: Baseline to Day 15
3. Pharmacokinetic parameter
AUC0-inf
Measured: 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 posted9 Apr 2025
- Study start5 Sep 2024
- Primary completion25 May 2025
- Study completion25 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile 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
- Model description
- An Open label, randomized, single-dose, two sequences, two-period , two-arm crossover comparative Pharmacokinetic, immunogenicity and safety study under fasting conditions.
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kashiv BioSciences, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr Pallav Bharpoda, MBBS PGDCR, Study director, Kashiv biosciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06918587
- Sponsor's protocol ID
- TPI-120 with On Body Injector
- Status last verified
- Apr 2026
- First submitted
- 31 Jan 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Randomized, Balanced, Two-treatment, Single Period, Parallel, Single Dose, Subcutaneous Administration, Comparative Pharmacokinetic Study Under Fasting Conditions.
- ClinicalTrials.gov ID
- NCT06918587
- Acronym / sponsor ID
- TPI-120 with On Body Injector
- Conditions
- Febrile Neutropenia
- Keywords
- pegfilgratim, on body injector
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Kashiv BioSciences, LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 25 May 2025 (actual)
- Study completion
- 25 May 2025 (actual)
- First posted
- 9 Apr 2025 (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 evaluate and To compare the pharmacokinetics (PK) of the Test product (T) getting administered through prefilled syringe with on-body injector with Reference product as prefilled syringe following a single 6 mg dose administered through subcutaneous route in healthy adult Human subjects.
Subjects safety and immunogenicity will also be evaluated during these study as follows Safety - monitoring the adverse events , vitals signs, ECG, laboratory parameters, and injection site assessment.
Immunogenicity assessment- detection of ADA (Anti-PEG antibody levels ) and Nab (Neutralizing antibodies) will be done pre-dose and post dose on day 15 of each period.
Detailed description
An Open label, randomized, single-dose, two sequences, two-period crossover comparative Pharmacokinetic, immunogenicity and safety study under fasting conditions. Duration of the clinical phase will be approximately 51 days starting from admission of period I until giving the last sample in period II.
A washout period of at least 34 days will be kept between dosing day in period I and dosing day period II.
Approximate volume of blood loss in the study will be 309 mL for both male and female's subjects. A total of Twenty-two (22) blood samples for PK parameters will be collected in SST tubes in each study period. Blood samples (5.0 mL) will be collected at pre-dose (00.00 hr) in the morning of dosing day (day 1) within 01.00 hour prior to dosing and at 00.33, 00.50, 00.75, 01.00, 02.00, 04.00, 06.00, 08.00, 10.00, 12.00,14.00, 16.00, 20.00, 24.00 (day 2), 36.00, 48.00 (day 3), 72.00 (day 4), 120.00 (day 6), 192.00 (day 9), 264.00 (day 12), 336.00 (day 15) hours post-dose during each study period.
Immunogenicity samples for ADA detection (anti-PEG- antibody) and Nab (Neutralizing antibodies) will be collected at pre- dose, and on day 15 (4.0 mL for each sampling time/ test) during each study period, into SST tubes.
Summary Statistics will be calculated for Pegfilgrastim pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf, Tmax, t12, Kel and AUC Extrapolated. Statistical tests like ANOVA, least square means for test and reference products, Two One- Sided Tests for 90% confidence interval limits and power will be calculated for In-transformed pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf Geometric least square means of test and reference products, it's ratio, 90% confidence interval for geometric least square means ratio and intra-subject variability will be calculated for pharmacokinetic parameters Cmax, AUC0-t and AUC0-inf for Pegfilgrastim.
Dose normalization for Cmax, AUC0-t and AUC0-inf will be done considering the actual administered dose for each subject (based on the difference in PFS/OBI/AI weight before and after dosing). This is an additional PK analysis dataset.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- An Open label, randomized, single-dose, two sequences, two-period , two-arm crossover comparative Pharmacokinetic, immunogenicity and safety study under fasting conditions.
| Arm | Type | Receives |
|---|---|---|
| Test Product TPI-120 with On body Injector 6 mg | Experimental | Device: TPI-120 with On body injectorTPI-120 pre-filled syringe 6 mg co-packaged with on body injector, manufactured by: Kashiv Biosciences LLC, USA. |
| Fylnetra | Active comparator | Drug: FylnteraFylnetra Pre-Filled Syringe 6 mg, manufactured by: Kashiv Biosciences LLC, USA. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Subjects are physically and mentally healthy adults aged between 18 and 50 years (both inclusive) at screening.
- Subject's weight within normal range according to normal values for Body Mass Index (18.5 to 30.0 kg/m2) (both inclusive) with minimum of 50 kg weight at screening.
- The findings of the subject are within the range of clinical acceptability in medical history, medication history, clinical examination, and laboratory examinations "other than RBC indices (MCH, MCV and MCHC) and hemoglobin" are within "normal ranges" or abnormalities considered insignificant and justified by the principal/clinical sub- Investigator at screening.
- The subject results of all RBC indices (MCH, MCV and MCHC) and hemoglobin are within normal range or ± 5% of medical lab reference range at screening.
- The subject's kidney function tests (Serum Creatinine, Potassium, Sodium) are within the medical lab reference range, and kidney function tests (urea, and chloride) are considered clinically acceptable as per the investigator judgment at screening. If creatinine is below the lower normal limit while the other parameters are normal, it will be considered as clinically not significant unless otherwise judged by the investigator.
Key exclusion criteria (25 listed)
- The subject has history of allergy or hypersensitivity to study drug or adhesive material or related class of drugs or to the inactive ingredients (acetate/acetic acid, polysorbate 20, or sorbitol) of the test and reference formulation as checked at screening.
- The subject has history or presence of significant cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunological, dermatological, neurological disease, or disorder as checked at screening or on admission day (before admission) of period I.
- The subject has an evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of the consent to participation in the study or limit the ability to comply with the protocol requirements, as determined by the principal investigator/clinical sub-investigator at screening or on admission day (before admission) of period I.
- The subject has a clinically significant history of skin disorders, including psoriasis or any clinically significant skin abnormality at injection site as checked at screening or on admission day (before admission) of period I.
- The subject has a history of any of the following, as checked at screening: Autoimmune disease.
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 with On body injectorTPI-120 pre-filled syringe 6 mg co-packaged with on-body injector, manufactured by: Kashiv Biosciences LLC, USA. | Device | Test Product TPI-120 with On body Injector 6 mg |
| FylnteraFylnetra Pre-Filled Syringe 6 mg, manufactured by: Kashiv Biosciences LLC, USA. | Drug | Fylnetra |
Primary outcome
Pharmacokinetic Parameter
Time frame: Baseline to Day 15
Cmax
Pharmacokinetic parameter
Time frame: Baseline to Day 15
AUC0-t
3. Pharmacokinetic parameter
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 20 Apr 2026.
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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.
Dr Pallav Bharpoda, MBBS PGDCR study director
Kashiv biosciences
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 with On body injector and Fylntera in people with Febrile Neutropenia, run by Kashiv BioSciences, LLC at 1 site in Jordan.
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 20 inclusion and 25 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 20 Apr 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 Jordan. 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 20 Apr 2026.