Pharmacokinetic, Immunogenicity, and Safety Evaluation of Pegfilgrastim TPI-120 in Healthy Adults (NCT07416955) | Clinical Trial Compass
CompletedPhase 1
Pharmacokinetic, Immunogenicity, and Safety Evaluation of Pegfilgrastim TPI-120 in Healthy Adults
United States180 participantsStarted 2025-04-05
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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
✕. 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.