A Comparative Evaluation of Pharmacokinetics and Immunogenicity.

NCT06918587 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: TPI-120 with On Body Injector
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Febrile Neutropenia

Keywords

pegfilgratim; on body injector

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic Parameter

  Cmax

  Baseline to Day 15

• Pharmacokinetic parameter

  AUC0-t

  Baseline to Day 15

• 3. Pharmacokinetic parameter

  AUC0-inf

  Baseline to Day 15

Study Arms (2)

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.

Device: TPI-120 with On body injector

Fylnetra

ACTIVE COMPARATOR

Fylnetra Pre-Filled Syringe 6 mg, manufactured by: Kashiv Biosciences LLC, USA.

Drug: Fylntera

Interventions

TPI-120 with On body injector DEVICE

TPI-120 pre-filled syringe 6 mg co-packaged with on-body injector, manufactured by: Kashiv Biosciences LLC, USA.

Test Product TPI-120 with On body Injector 6 mg

Fylntera DRUG

Fylnetra Pre-Filled Syringe 6 mg, manufactured by: Kashiv Biosciences LLC, USA.

Fylnetra

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• The subject's Cholesterol level is considered clinically acceptable as per PI / SI judgment at screening.
• The subject is fasting for at least 12 hrs before giving the samples required for clinical laboratory examinations as checked at screening .
• 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.
• The subject has a normal ECG (12 leads) as per the investigator judgement, at screening and on admission day (before admission) of period I.
• 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.
• 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 .
• The subject has negative alcohol test at screening and on admission day (before admission) of period I.
• 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":

You may not qualify if:

• 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.
• 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.
• History or presence of significant gastric and/or duodenal ulceration as checked at screening.
• The subject has received any vaccination (including influenza) within 60 days prior to first dosing as checked at screening.
• 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.
• 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.
• 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.
• Difficulty with donating blood as checked at screening or on admission day (before admission) of period I.

Sponsors & Collaborators

• Kashiv BioSciences, LLC: lead

Study Sites (1)

Al-Essra Hospital

Amman, Jordan, 11941, Jordan

Location

MeSH Terms

Conditions

Febrile Neutropenia

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Dr Pallav Bharpoda, MBBS PGDCR

  Kashiv biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: An Open label, randomized, single-dose, two sequences, two-period , two-arm crossover comparative Pharmacokinetic, immunogenicity and safety study under fasting conditions.

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: April 9, 2025
• Study Start: September 5, 2024
• Primary Completion: May 25, 2025
• Study Completion: May 25, 2025
• Last Updated: April 20, 2026

Record last verified: 2026-04

Locations

JO (1)