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Healthy VolunteersPhase 1TPI-120NCT03206229

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

A Phase 1 study testing PEG-rhG-CSF and Neulasta (PEG-rhG-CSF) in people with Healthy Volunteers, run by Adello Biologics, LLC at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
PEG-rhG-CSF and Neulasta (PEG-rhG-CSF)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
13 Feb 2017to 18 Jan 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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
  • Donation of plasma within 7 days of dosing; blood donation or significant loss of blood within 30 days of dosing.
  • Participation in a clinical trial involving the administration of an investigational drug or marketed drug within 30 days prior to initial dosing (90 days for biologics) or concomitant participation in an investigational study involving no drug administration.
  • Females who are breast-feeding or lactating.
  • 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 of cancer
  • Subjects who are on a special diet or who have self-reported a weight loss of more than 15 pounds within 1 month prior to initial dosing.
  • Acute viral or bacterial infection within 1 month prior to initial dosing only if considered clinically significant in the opinion of the Principal Investigator/designee.
  • History of any clinically significant disease or condition that, in the opinion of the Principal Investigator/designee, would render them unsuitable for inclusion in the study.
  • Any vaccination (including influenza) within 90 days prior to initial dosing.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • WCCT Global Inc.

    Cypress, California, 90630

Other trials in United States

About this study

Official title: A Randomized, Double Blind, Single-Dose, Two-Period Crossover Comparative Pharmacology Study Comparing TPI-120 and Neulasta® Administered Through Subcutaneous Route in Healthy Adult Subjects

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.

Read the detailed description

The current study design was prepared to assess and compare the PK, PD, safety, tolerability of the Adello biosimilar candidate, TPI-120 and the US-licensed reference product, Neulasta® after administering a single subcutaneous 2 mg dose in healthy adult subjects in a crossover design. The primary PK parameters are AUC0-t, AUC0-inf, and Cmax, and the primary PD parameters are baseline-corrected AUEC0-t and Emax for ANC.

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.

Being tested
PEG-rhG-CSF, Neulasta (PEG-rhG-CSF)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PEG-rhG-CSFDrug

    Also called PEGFILGRASTIM

    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

  • Neulasta (PEG-rhG-CSF)Drug

    Also called PEGFILGRASTIM

    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

Study groups in NCT03206229
Study groupRoleWhat they receive
TPI-120 (PEG-rhG-CSF)ExperimentalPEG-rhG-CSF (recombinant granulocyte-colony stimulating factor conjugated with monomethoxypolyethylene glycol) Adello Biologics, LLC, Chicago, IL
Receives: Drug: PEG-rhG-CSF
Neulasta (PEG-rhG-CSF)Active comparatorNeulasta®, (PEG-rhG-CSF) Amgen, Thousand Oaks, CA
Receives: Drug: Neulasta (PEG-rhG-CSF)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum observed concentration (Cmax)

    To evaluate the pharmacokinetics

    Measured: 56 days

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

    To evaluate the pharmacokinetics

    Measured: 56 days

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

    To evaluate the pharmacokinetics

    Measured: 56 days

Secondary outcomes (2)

  1. Safety Variable - Tolerability as measured by Injection Site reactions

    Tolerability as measured by Injection Site reactions

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

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

    Immunogenicity as measured by presence of Anti Drug Antibodies

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2017
  2. Study start13 Feb 2017
  3. Primary completion2 Jun 2017
  4. Study completion18 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
This study is a Randomized, Double Blind, Single-Dose, Two-Period Crossover Comparative Pharmacology Study
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03206229
Sponsor's protocol ID
TPI-CL-109-A
Acronym
TPI-120
Status last verified
Jul 2018
First submitted
12 Apr 2017
Last updated
3 Jul 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Later on management will decide whether to share the data or not

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PEG-rhG-CSF and Neulasta (PEG-rhG-CSF) in people with Healthy Volunteers, run by Adello Biologics, LLC at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum observed concentration (Cmax) (time frame: 56 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03206229.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2018; AzTrials last refreshed its copy on 30 Oct 2026.

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