Healthy VolunteersPhase 1TPI-120NCT03202927
Comparative Immunogenicity Study Comparing TPI-120 to Neulasta® in Healthy Adult Subjects
A Phase 1 study testing PEGFILGRASTIM in people with Healthy Volunteers, run by Adello Biologics, LLC at 2 sites in United States.
Trial summary
This study will compare treatment emergent incidence rate of ADA between TPI-120 and US licensed Neulasta in normal healthy adult subjects 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?
- PEGFILGRASTIM
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 2 sitesUnited States
- Study dates
- 25 Mar 2017to 12 Apr 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 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.
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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 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.
Who cannot join
- 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.
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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 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
- Donation of plasma within 7 days of initial dosing; blood donation or significant loss of blood within 30 days of initial 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
2 sites in 1 country.
United States2 sites
Celerion Inc.
Lincoln, Nebraska, 68502
Celerion Inc.
Tempe, Arizona, 85283
About this study
Official title: A Randomized, Single Blind, Repeat-dose, Two Cycle, Parallel-Arm Comparative Immunogenicity Study Comparing TPI-120 to Neulasta® in Healthy Adult Subjects
This study will compare treatment emergent incidence rate of ADA between TPI-120 and US licensed Neulasta in normal healthy adult subjects
Read the detailed description
Healthy subjects have been selected as the study population for this comparative study because this population is more homogenous with respect to immune response and offers significant advantages with regards to recruitment and logistical aspects. This study will comprise of two cycles with each cycles will have a single dose of PEG FILGRASTIM administration to all study subjects as per the randomization schedule. Subjects will be confined from at least 10 hours prior to dosing, at the time indicated by the CRU, until 36 hours post-dose on day 2 in each Cycle. Dosing in each Cycle are separated by 21 days.
Subjects will return for all subsequent blood draws and ADA assessments, as indicated in The Schedule of Event
- Conditions
- Healthy Volunteers
- Being tested
- PEGFILGRASTIM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEGFILGRASTIMDrug
Also called PEG GCSF, Neulasta
Pegfilgrastim is a covalent conjugate of recombinant methionyl human granulocyte colony-stimulating factor and monomethoxy polyethylene glycol.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: PEGFILGRASTIM |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Tolerability as measured by Injection Site reactions
Measured: 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
Immunogenicity as measured by presence of Anti Drug Antibodies
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2017
- Study start25 Mar 2017
- Primary completion1 Mar 2018
- Study completion12 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Model description
- This is a single blind parallel comparative immunogenicity study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adello Biologics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Celerion
- Responsible party
- Principal investigator, Dr. Prayag Shah, Adello Biologics, LLC
- Investigators
- Cindy Cui, MD, Study director, Adello Biologics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03202927
- Sponsor's protocol ID
- ADL-CL-112
- Acronym
- TPI-120
- Status last verified
- Jul 2018
- First submitted
- 25 Apr 2017
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Sponsor will decide later on
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single Blind, Repeat-dose, Two Cycle, Parallel-Arm Comparative Immunogenicity Study Comparing TPI-120 to Neulasta® in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT03202927
- Acronym / sponsor ID
- TPI-120 / ADL-CL-112
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Adello Biologics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Celerion
- Study start
- 25 Mar 2017 (actual)
- Primary completion
- 1 Mar 2018 (actual)
- Study completion
- 12 Apr 2018 (actual)
- First posted
- 29 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare treatment emergent incidence rate of ADA between TPI-120 and US licensed Neulasta in normal healthy adult subjects
Detailed description
Healthy subjects have been selected as the study population for this comparative study because this population is more homogenous with respect to immune response and offers significant advantages with regards to recruitment and logistical aspects. This study will comprise of two cycles with each cycles will have a single dose of PEG FILGRASTIM administration to all study subjects as per the randomization schedule. Subjects will be confined from at least 10 hours prior to dosing, at the time indicated by the CRU, until 36 hours post-dose on day 2 in each Cycle. Dosing in each Cycle are separated by 21 days.
Subjects will return for all subsequent blood draws and ADA assessments, as indicated in The Schedule of Event
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a single blind parallel comparative immunogenicity study
| Arm | Type | Receives |
|---|---|---|
| TPI-120 (PEGFILGRASTIM) | Experimental | Drug: PEGFILGRASTIMOne 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 |
| Neulasta (PEGFILGRASTIM) | Active comparator | Drug: PEGFILGRASTIMOne 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 |
Who may qualify
- Ages
- 19 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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:
- 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.
Key exclusion criteria (25 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PEGFILGRASTIMAlso: PEG GCSF, NeulastaPegfilgrastim is a covalent conjugate of recombinant methionyl human granulocyte colony-stimulating factor and monomethoxy polyethylene glycol. | Drug | Neulasta (PEGFILGRASTIM), TPI-120 (PEGFILGRASTIM) |
Primary outcome
Treatment emergent ADA incidence rate
Time frame: 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
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
2 secondary outcomes
Safety Variable - Tolerability as measured by Injection Site reactions
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Individual participant dataSharing planned: No. Sponsor will decide later on
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy Cui, MD study director
Adello Biologics, LLC
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PEGFILGRASTIM in people with Healthy Volunteers, run by Adello Biologics, LLC at 2 sites 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 5 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 2 sites 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?
Treatment emergent ADA incidence rate (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2018.