Study Comparing TPI-120 and Neulasta Administered Through Subcutaneous Route in Healthy Adult Subjects

NCT03206229 | Completed Phase 1 FDA Drug

• 1 other identifier: TPI-CL-109-A
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single or up to 2 centers, double-blind, randomized, single-dose, two-way, crossover study comparing the Test (T) and Reference (R) products following subcutaneous administration. Subjects will be randomly assigned to one of two treatments sequences (TR or RT). All subjects will be dosed at the CRO's designated clinical site(s) and the same protocol requirements and procedures will be followed within each group.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

• Maximum observed concentration (Cmax)

  To evaluate the pharmacokinetics

  56 days

• Area under the concentration-time curve from time zero to the time of the last non-zero concentration (AUC0-t)

  To evaluate the pharmacokinetics

  56 days

• Area under the concentration-time curve from time zero to infinity (extrapolated AUC0-inf)

  To evaluate the pharmacokinetics

  56 days

Secondary Outcomes (2)

• Safety Variable - Tolerability as measured by Injection Site reactions

  1, 2, 4, and 24 hours postdose during each study period

• Safety Variable - Immunogenicity as measured by presence of Anti Drug Antibodies

  Day 1 of each study period & Day 22 of each study period

Study Arms (2)

TPI-120 (PEG-rhG-CSF)

EXPERIMENTAL

PEG-rhG-CSF (recombinant granulocyte-colony stimulating factor conjugated with monomethoxypolyethylene glycol) Adello Biologics, LLC, Chicago, IL

Drug: PEG-rhG-CSF

Neulasta (PEG-rhG-CSF)

ACTIVE COMPARATOR

Neulasta®, (PEG-rhG-CSF) Amgen, Thousand Oaks, CA

Drug: Neulasta (PEG-rhG-CSF)

Interventions

PEG-rhG-CSF DRUG

PEG-rhG-CSF is going to be administered 2 mg/0.2 ml subcutaneously single dose in each study period as per the randomization schedule

Also known as: PEGFILGRASTIM

TPI-120 (PEG-rhG-CSF)

Neulasta (PEG-rhG-CSF) DRUG

PEG-rhG-CSF is going to be administered 2 mg/0.2 ml subcutaneously single dose in each study period as per the randomization schedule

Also known as: PEGFILGRASTIM

Neulasta (PEG-rhG-CSF)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female, non-smoker (no use of tobacco or nicotine products within 3 months prior to dosing), 19 - 55 years of age (inclusive), with body mass index (BMI) ≥ 19 and ≤ 30 kg/m2, and body weight not \< 50 kg or \> 100 kg at the time of screening.
• Healthy as defined by:
• The absence of clinically significant (in the opinion of the PI/designee) illness or surgery within 4 weeks prior to dosing.
• The absence of a clinically significant (in the opinion of the PI/designee) history of disease.
• WBC (white blood cell) \> 4.0 x 109/L and \< 1.5 times the upper limit of normal (ULN), ANC (absolute neutrophil count) \> 2.0 x 109/L and \< 1.5 times the upper limit of normal (ULN), Platelet count \> 150 x 109/L, AST (aspartate aminotransferase) \< 2.5 time the upper limit of normal (ULN), ALT (alanine aminotransferase) \< 2.5 time the upper limit of normal (ULN), Serum bilirubin \< 1.5 time the upper limit of normal (ULN) and Serum creatinine \< 1.5 time the upper limit of normal (ULN). \[Refer to APPENDIX 1 for normal reference ranges\]
• The absence of febrile (defined by a documented oral temperature of 101.5 °F or greater) or infectious illness within 1 week of first dosing.
• The absence of a clinically significant history of skin disorders, including psoriasis.
• Females of childbearing potential must be willing to use acceptable contraceptive methods throughout the study, and for 30 days thereafter.
• 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.
• Capable of consent.
• Male subjects willing to follow approved birth control method for the duration of the study, and for 30 days thereafter, such as (a double barrier method) vasectomy, condom with spermicide, condom with diaphragm or abstinence, subject should also not donate sperm during this time.

You may not qualify if:

• Positive test for hepatitis B, hepatitis C, or HIV.
• Illicit/illegal drug use as evidenced by a positive test for alcohol or drug screen at screening or check -in.
• Positive result for urine alcohol test at screening or check-in
• Tobacco use as evidenced by a positive cotinine result at screening or check-in.
• History of allergic reactions to pegfilgrastim, filgrastim, Escherichia coli (E. coli)-derived proteins, or other related drugs. History of allergic reactions or hypersensitivity to acetate/acetic acid, polysorbate 20, or sorbitol.
• Hereditary fructose intolerance.
• Females with positive pregnancy tests at screening or check-in.
• Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study or completing follow-up activities.
• Clinically significant ECG or vital sign abnormalities at screening.
• History of significant alcohol abuse within one year prior to initial dosing or regular use of alcohol (more than 14 units of alcohol per week) within six months prior to initial dosing.
• History of drug abuse or use of illicit/illegal drugs within 1 year prior to initial dosing.
• No medications are permitted during the study. Exceptions are:
• Hormonal contraceptives and Hormone Replacement Therapy (HRT),
• Thyroid replacement therapy i.e., liothyronine (T3) or levothyroxine (T4).
• Acetaminophen

Sponsors & Collaborators

• Adello Biologics, LLC: lead
• inVentiv Health Clinical: collaborator

Study Sites (1)

WCCT Global Inc.

Cypress, California, 90630, United States

Location

MeSH Terms

Interventions

pegylated granulocyte colony-stimulating factor; pegfilgrastim

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is double blind study so participat healthy subjects and investigators both would be blinded
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: This study is a Randomized, Double Blind, Single-Dose, Two-Period Crossover Comparative Pharmacology Study

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: July 2, 2017
• Study Start: February 13, 2017
• Primary Completion: June 2, 2017
• Study Completion: January 18, 2018
• Last Updated: July 3, 2018

Record last verified: 2018-07

Locations

US (1)