Pharmacokinetic, Immunogenicity, and Safety Evaluation of Pegfilgrastim TPI-120 in Healthy Adults
NCT07416955
Phase
Phase 1
Recruitment status
Completed
Participants
Lead sponsor
Kashiv BioSciences, LLC
Start date
2025-04-05
Number of sites
- 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 manufactured by Kashiv Biosciences LLC, USA in healthy, adult human subjects and also to assess safety and tolerability of investigational product.
- Short title
- Pharmacokinetic, Immunogenicity, and Safety Evaluation of Pegfilgrastim TPI-120 in Healthy Adults
- 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
- Control arm
- Active comparator
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2025-10-10
- First posted
- 2026-02-18
- Registry last updated
- 2026-02-18
- Primary completion date
- 2025-10-10
- Start date
- 2025-04-05
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Kashiv BioSciences, LLC
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07416955
- ClinicalTrials.gov ID
- NCT07416955
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Crossover
- Purpose
- Treatment
- Masking
- No masking
Sources for study design
Pharmacokinetic parameter
Timeframe: Baseline to Day 15
Cmax,
Pharmacokinetic parameter
Timeframe: Time Frame: Baseline to Day 15
AUCt
Pharmacokinetic parameter
Timeframe: Time Frame: Baseline to Day 15
AUC0-inf
Sources for outcomes
- Sex
- All
- Age groups
- Adults
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Healthy volunteers
- Yes
- 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
- 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
- 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
- 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.
Sources for eligibility
- Cliantha ResearchSt. Petersburg, United States
Sources for sites
Related records
Drugs (1)
Collaborators (1)
- Cliantha Research