Comparative Immunogenicity Study Comparing TPI-120 to Neulasta® in Healthy Adult Subjects

NCT03202927 | Completed Phase 1 FDA Drug

• 1 other identifier: ADL-CL-112
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 2

Brief Summary

This study will compare treatment emergent incidence rate of ADA between TPI-120 and US licensed Neulasta in normal healthy adult subjects

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Treatment emergent ADA incidence rate

  Treatment emergent ADA levels for TPI-120 and Neulasta® will be estimated and compared to evaluate potential differences between the two products in the incidence of ADA human immune responses

  Pre dose Day 1 (Day 1 of Cycle 1), Day 8 ± 1, Day 21 ± 1, prior to dosing on Day 1 of Cycle 2), Day 29 ± 1, Day 58 ± 1

Secondary Outcomes (2)

• Safety Variable - Tolerability as measured by Injection Site reactions

  0.5, 2, 4, 6, 12 (Day 1), 24 (Day 2) hours post dose in each cycle

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

  Day 1 of Cycle 1, On Study Day 8 ± 1, On Study Day 21 ± 1, Day 1 of Cycle 2), On Study Day 29 ± 1, On Study Day 58 ± 1

Study Arms (2)

TPI-120 (PEGFILGRASTIM)

EXPERIMENTAL

One daily dose of TPI-120 (PEGFILGRASTIM) 6 mg/0.6 ml administered subcutaneously on Day 1 (Study Day 1) of Cycle 1 followed by one daily dose of 6 mg/0.6 ml administered subcutaneously on Day 1 (Study Day 22) of Cycle 2 with a gap of 21 days between two cycles

Drug: PEGFILGRASTIM

Neulasta (PEGFILGRASTIM)

ACTIVE COMPARATOR

One daily dose of Neulasta (PEGFILGRASTIM) 6 mg/0.6 ml administered subcutaneously on Day 1 (Study Day 1) of Cycle 1 followed by one daily dose of 6 mg/0.6 ml administered subcutaneously on Day 1 (Study Day 22) of Cycle 2 with a gap of 21 days between two cycles

Drug: PEGFILGRASTIM

Interventions

PEGFILGRASTIM DRUG

Pegfilgrastim is a covalent conjugate of recombinant methionyl human granulocyte colony-stimulating factor and monomethoxy polyethylene glycol.

Also known as: PEG GCSF, Neulasta

Neulasta (PEGFILGRASTIM); TPI-120 (PEGFILGRASTIM)

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 initial 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) at the time of screening. \[Refer to APPENDIX 1 for normal reference ranges\]
• 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 and willing 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) condom with spermicide, condom with diaphragm or abstinence, subject should also not donate sperm during this time.

You may not qualify if:

• Any positive test for hepatitis B, hepatitis C, or HIV at the time of screening.
• Illicit/illegal drug use as evidenced by a positive 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 signs 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
• Celerion: collaborator

Study Sites (2)

Celerion Inc.

Tempe, Arizona, 85283, United States

Location

Celerion Inc.

Lincoln, Nebraska, 68502, United States

Location

MeSH Terms

Interventions

pegfilgrastim

Study Officials

• Cindy Cui, MD

  Adello Biologics, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: As this is single blind study so study participants would be blinded in the study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Model Details: This is a single blind parallel comparative immunogenicity study

Study Record Dates

• First Submitted: April 25, 2017
• First Posted: June 29, 2017
• Study Start: March 25, 2017
• Primary Completion: March 1, 2018
• Study Completion: April 12, 2018
• Last Updated: July 5, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)