HealthyPhase 1NCT04651036
A Phase 1 Study to Assess the Immunogenicity of QL0605 Compared to US Neulasta in Healthy Subjects
A Phase 1 study testing QL0605 and US Neulasta in people with Healthy, run by Qilu Pharmaceutical Co., Ltd. at 2 sites in 2 countries.
Trial summary
The study was an assessor-blind, balanced, parallel, randomized, two-treatment, comparative immunogenicity study of multiple doses of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6 mL; Qilu Pharmaceutical Co., Ltd. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- QL0605 and US Neulasta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Nov 2020to 30 Nov 2022
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must give written informed consent before any assessment is performed;
- Subjects must be a healthy male or female aged 18 to 55 years (both inclusive) at the time of informed consent;
- Body weight ≥60 kg (males) or ≥50 kg (females) at the Screening Visit;
- The Body Mass Index (BMI) between 18.5 to 29.9 kg/m2 (inclusive) at the Screening Visit (BMI = Body weight (kg)/[Height (m)]2);
- Absolute neutrophil count and total leukocyte count are within the normal laboratory reference ranges; platelet count, hematocrit, and haemoglobin results are not below the lower limit of laboratory reference ranges; reticulocyte count is not above the upper limit of laboratory reference ranges; all other laboratory parameters within reference ranges or showing no clinically relevant deviations as judged by the Investigator. If the results of the laboratory parameters (other than total leukocyte count, platelet count, neutrophil count, hematocrit, reticulocyte count and hemoglobin) are outside the normal reference ranges, the subject may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate for the population under study;
- Female subjects must either be:
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- of non-childbearing potential:
- Postmenopausal (defined as at least 1 year without any menses) prior to the Screening Visit, and the follicle stimulating hormone levels indicative of menopause according to local laboratory reference ranges at Screening, or
- Documented permanent surgically sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) since at least 6 weeks before the Screening Visit
- or, if of childbearing potential:
- Agree not to try to become pregnant during the clinical study and for 49 days after the last IMP administration and
- Must have a negative serum pregnancy test at screening and
- If heterosexually active, agree to consistently use 2 forms of birth control (1 of which is a highly effective method† and 1 must be a barrier method‡) from screening and throughout the study period, and for 49 days after last IMP administration. The highly effective method of contraception should be stable for at least 28 days prior to first IMP administration.
- Highly effective forms of birth control include (i.e., less than 1% failure rate per year when used consistently and correctly):
- Consistent and correct usage of established oral contraception (this is considered highly effective, because it is used in combination with a barrier method)
- Injected or implanted hormonal methods of contraception
- Established (with a failure rate < 1%) intrauterine device (IUD) or intrauterine system (IUS)
- Bilateral tubal ligation
- Any male partner that has undergone effective surgical sterilization, provided that the partner is the sole sexual partner of the female study participant
- Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments and complies with the preferred and usual lifestyle of the subject.
- ‡ Barrier methods of birth control include for males and females:
- Condom without spermicidal foam/gel/film/cream/suppository or fat- or oil containing lubricant.
- Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- Female subjects must agree not to breastfeed starting at the Screening Visit and throughout the clinical study period, and for 49 days after last IMP administration;
- Female subjects must not donate ova starting at the Screening Visit and throughout the clinical study period, until the final Follow-up Visit;
- Male subjects and their female spouse/partners who are of childbearing potential must be using 2 forms of birth control (1 of which is a highly effective method† and 1 must be a barrier method‡) starting at the Screening Visit and throughout the study period and for 49 days after the last IMP administration. A condom is required to be used also by vasectomized men to prevent delivery of the drug via seminal fluid;
- Subjects must be non-smoker, or light smokers who smoke not more than 5 cigarettes or 1 cigar or 1 pipe per day and who agree to abstain from smoking while resident at the clinical unit.
Who cannot join
- Known previous exposure to filgrastim, pegfilgrastim, granulocyte colony stimulating factor (G-CSF) or any analogue of these;
- Positive test results for anti-PEG-GCSF-antibodies at the Screening Visit or based on historical data (not older than 3 months);
- Known hypersensitivity to the study drug or any of its constituents (e.g., fructose intolerance), hypersensitivity to Escherichia coli derived proteins;
- History of an acute severe allergic reaction (e.g., anaphylaxis; delayed hypersensitivity reaction); concurrent or history of moderate to severe allergy requiring medical treatment (including moderate seasonal allergies); concurrent or history of clinically significant latex allergy;
- Current evidence of atopic eczema or allergic bronchial asthma;
- History or current evidence of any clinically significant condition that might interfere with the distribution, metabolism or excretion of the any of the investigational drugs;
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- Concurrent or history of cardiac, hepatic, renal, gastrointestinal, respiratory, neurological, central nervous, mental disorders and/or hematological function disorders, which, in the judgment of the Investigator or any of the Sub-Investigators, may affect participation in this clinical study;
- Clinically significant vital sign abnormalities or systolic blood pressure [BP] < 90 or > 139 mmHg, diastolic BP < 50 or > 89 mmHg, and/or pulse < 50 or > 90 beats per minute [bpm] at the Screening Visit (mean of triplicate measurements);
- Subjects with abnormal 12-lead Electrocardiograms (ECGs) (QTcF >450 ms in males and 470 ms in females, signs of ischemia, sinus tachycardia [heart rate, HR >90] or sinus bradycardia [HR <50], ventricular conduct delay [QRS >120 ms] or others) which, in the judgment of the Investigator or any of the Sub-investigators, may be clinically relevant;
- Renal impairment with estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73 m2, based on creatinine clearance calculation by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula.
- Any clinically relevant laboratory findings that, in the opinion of the Investigator, would preclude inclusion in the trial; including alanine aminotransferase (ALT), aspartate aminotransferase (AST), and bilirubin (total) > upper limit of normal (ULN). If any of these tests are out-of-range, the tests can be repeated once;
- Previous or concurrent malignancy;
- First degree relatives with hematological malignancy;
- Clinically significant active infection within 4 weeks before IMP administration;
- Any past or concurrent medical conditions that potentially increase the subject's risks or affect the evaluation of any study results, like medical history with evidence of clinically relevant pathology e.g., sickle cell disorders, spleen pathologies, hematologic malignancies or myelodysplastic disorders, and pulmonary illnesses such as Acute Respiratory Distress Syndrome, interstitial pneumonia, pulmonary edema, pulmonary infiltrates and pulmonary fibrosis;
- Subject exhibiting spleen enlargement (as determined by ultrasound assessment) or other relevant abnormality which is, at the discretion of the Investigator, a contraindication for treatment with pegfilgrastim;
- Presence of any clinically significant finding that, in the opinion of the Investigator, would preclude continuation in the study;
- Participation (last dosing) in a previous clinical trial with an experimental drug within 3 months before the first administration of the IMP or five half lives of the drug, whichever is longer, prior to dosing;
- Use of depot injectable solutions within 6 months before IMP administration. Hormonal depot injections for contraception or hormonal replacement therapy are allowed;
- Intake of drugs and/or drugs with a long half-life within 4 weeks before IMP administration;
- Positive test results for hepatitis B surface antigen (HbsAg), anti hepatitis B core (anti-HBc) antibodies indicative of active hepatitis, hepatitis A virus antibodies (immunoglobulin M [IgM]), hepatitis C virus (HCV) antibodies or human immunodeficiency virus (HIV) type-1 and/or type-2 antibodies at the Screening Visit;
- Has a history of chronic drug or alcohol abuse in the last 5 years before the date of administration of the IMP and/or positive urine drugs of abuse tests (phencyclidines, benzodiazepines, cocaine, amphetamines/ methamphetamines, cannabinoids, opiates, barbiturates, and tricyclic antidepressant drugs) and / or positive alcohol urine test at screening and admission;
- Subjects who regularly consume large quantities of alcohol.
- For Berlin unit: drinking > 168 g (males) and > 84 g (females) pure alcohol per week (10 g pure alcohol = 250 mL of beer [5%] or 35 mL of spirits [35%] or 125 mL of wine [10%]) within 3 months prior to admission to the clinical unit;
- For London unit: drinking > 21 units (males) and > 14 units (females) of alcohol per week (beer 5%, 259 ml = 10.36 g , wine 10% 100 ml = 8 g and Spirits 40% 35 ml = 11.20 g);
- Not willing to abstain from xanthine-containing products from 24 hours prior to the Screening Visit and prior to the admission visit [Day -1] and during the in-house stay, and at all other times, to limit the consumption of caffeinated beverages or xanthine-containing products to no more than 6 units per day (1 unit = 120 mg of caffeine);
- Plasma donation within 1 month before the Screening Visit or any blood donation / blood loss > 500 mL during the 3 months before the Screening Visit, or any planned blood donation during the time the subject is on study;
- Use of any prescription drug (excluding hormonal contraceptives, hormone replacement therapy, and topical medications used for local treatment) or any over-the-counter drug (except ibuprofen and paracetamol) within the 2 weeks (or less than 5 x the half-life of that medication, whichever is longer) before the Baseline Visit in Period 1, which, in the judgment of the Investigator or Sub-Investigators, may affect participation in this clinical study; vitamins, minerals and nutritional supplements may be taken at the discretion of the Investigator;
- Subjects being on a special diet or with significant weight loss from a weight reduction diet (e.g. more than approx. 5 kg within 1 month) before the Screening Visit or unwilling to maintain the same weight for the duration of the study;
- Not willing to avoid poppy seeds and foods containing them for 72 hours prior to Screening and Day -1 visits;
- A current (suspected or confirmed) pregnancy or currently nursing (women only);
- Vulnerable subjects (i.e., persons under any administrative or legal supervision or persons kept in detention);
- Subjects who are employees of Sponsor, clinical research organization (CRO) or who is the Investigator or any sub-Investigator, research assistant, pharmacist, study coordinator, other site staff or relative thereof directly involved in the conduct of the clinical study;
- Subjects who are not able to read, speak and understand the German language (Berlin unit) or the English language (London unit);
- Any psychological or emotional problems/disorders or resultant therapy that is likely to invalidate informed consent, or limit the ability of the subject to comply with the protocol requirements.
- Subject has a positive PCR test result for SARS-CoV-2 before randomization.
- Subject has clinical signs and symptoms consistent with COVID-19, e.g., fever, dry cough, dyspnea, sore throat, fatigue or confirmed current infection by appropriate laboratory test within the last 4 weeks prior to or at screening or on admission.
- Subject who had severe course of COVID-19 (extracorporeal membrane oxygenation [ECMO], mechanically ventilated).
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site, 1 recruiting
- Not yet recruiting
Parexel International GmbH Early Phase Clinical Unit Berlin
Berlin
Thomas Koernicke
Thomas Koernicke
United Kingdom1 site, 1 recruiting
- Recruiting
Parexel Early Phase Clinical Unit
London
Jana Wolfova
About this study
Official title: A Randomized, Double-blind, 2-period Parallel-arm Study to Assess the Immunogenicity of 2 Subcutaneous Doses of QL0605 (6 mg) Compared to 2 Subcutaneous Doses of US Neulasta P®P (6 mg) in Healthy Male and Female Subjects
The study was an assessor-blind, balanced, parallel, randomized, two-treatment, comparative immunogenicity study of multiple doses of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6 mL; Qilu Pharmaceutical Co., Ltd. proposed biosimilar QL0605 compared to innovator product, US-Neulasta) in healthy, adult, human subjects.
Read the detailed description
This is a multi-center, randomized, double-blind, single-dose, 2-period parallel-arm study designed to assess the immunogenicity of QL0605 and US-Neulasta.
A total of 300 healthy male and female subjects aged 18-55 years (inclusive) will be included and randomized to receive either 2 s.c. doses of QL0605 or US-NeulastaP®P in a ratio of 1:1. After the Screening Period of up to 4 weeks the subject will be randomly allocated to one of the 2 parallel treatment arms. All subjects will receive 1 s.c. injection of 6 mg QL0605 or 6 mg NeulastaP®P (US) in Treatment Period 1 and 1 s.c. injection of 6 mg QL0605 or 6 mg NeulastaP®P in Treatment Period 2. The interval between doses is ≥ 42 days.
- Conditions
- Healthy
- Being tested
- QL0605, US Neulasta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL0605Drug
Also called pegfilgrastim
a pegfilgrastim biosimilar to US Neulasta.
US NeulastaDrug
Also called pegfilgrastim
US Neulasta
| Study group | Role | What they receive |
|---|---|---|
| Pegfilgrastim biosimilar product | Experimental | QL0605 subcutaneously at a dose of 6 mg/0.6 mL. Receives: Drug: QL0605 |
| US Neulasta | Active comparator | US Neulasta subcutaneously at a dose of 6 mg/0.6 mL. Receives: Drug: US Neulasta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence (absolute and percentage) of ADA by treatment
Incidence (absolute and percentage) of anti-drug antibody by treatment
Measured: 91 days
Secondary outcomes (6)
AUC0-t
Area under the concentration-time curve (AUC) from time zero to last quantifiable concentration
Measured: 91 days
AUCinf
Area under the concentration-time curve (AUC) from time zero to infinity
Measured: 91 days
Cmax
Maximum serum concentration
Measured: 91 days
tmax
time corresponding to the occurrence of Cmax
Measured: 91 days
AUEC(0-Day41)
Area under the ANC-time curve (AUC) from time zero to day41
Measured: 41 days
ANC Emax
Maximum ANC concentration
Measured: 91 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start6 Nov 2020
- Primary completion30 Nov 2021 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Koernicke, MD, Principal investigator, Parexel International GmbH Early Phase Clinical Unit Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04651036
- Sponsor's protocol ID
- QL0605-OVE-002
- Status last verified
- Nov 2020
- First submitted
- 9 Nov 2020
- Last updated
- 3 Dec 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, 2-period Parallel-arm Study to Assess the Immunogenicity of 2 Subcutaneous Doses of QL0605 (6 mg) Compared to 2 Subcutaneous Doses of US Neulasta P®P (6 mg) in Healthy Male and Female Subjects
- ClinicalTrials.gov ID
- NCT04651036
- Acronym / sponsor ID
- QL0605-OVE-002
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 3 Dec 2020 (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.
The study was an assessor-blind, balanced, parallel, randomized, two-treatment, comparative immunogenicity study of multiple doses of subcutaneous (SC) Pegfilgrastim injection (6 mg/0.6 mL; Qilu Pharmaceutical Co., Ltd. proposed biosimilar QL0605 compared to innovator product, US-Neulasta) in healthy, adult, human subjects.
Detailed description
This is a multi-center, randomized, double-blind, single-dose, 2-period parallel-arm study designed to assess the immunogenicity of QL0605 and US-Neulasta.
A total of 300 healthy male and female subjects aged 18-55 years (inclusive) will be included and randomized to receive either 2 s.c. doses of QL0605 or US-NeulastaP®P in a ratio of 1:1. After the Screening Period of up to 4 weeks the subject will be randomly allocated to one of the 2 parallel treatment arms. All subjects will receive 1 s.c. injection of 6 mg QL0605 or 6 mg NeulastaP®P (US) in Treatment Period 1 and 1 s.c. injection of 6 mg QL0605 or 6 mg NeulastaP®P in Treatment Period 2. The interval between doses is ≥ 42 days.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Pegfilgrastim biosimilar product | Experimental | Drug: QL0605QL0605 subcutaneously at a dose of 6 mg/0.6 mL. |
| US Neulasta | Active comparator | Drug: US NeulastaUS Neulasta subcutaneously at a dose of 6 mg/0.6 mL. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (27 listed)
- Subjects must give written informed consent before any assessment is performed;
- Subjects must be a healthy male or female aged 18 to 55 years (both inclusive) at the time of informed consent;
- Body weight ≥60 kg (males) or ≥50 kg (females) at the Screening Visit;
- The Body Mass Index (BMI) between 18.5 to 29.9 kg/m2 (inclusive) at the Screening Visit (BMI = Body weight (kg)/[Height (m)]2);
- Absolute neutrophil count and total leukocyte count are within the normal laboratory reference ranges; platelet count, hematocrit, and haemoglobin results are not below the lower limit of laboratory reference ranges; reticulocyte count is not above the upper limit of laboratory reference ranges; all other laboratory parameters within reference ranges or showing no clinically relevant deviations as judged by the Investigator. If the results of the laboratory parameters (other than total leukocyte count, platelet count, neutrophil count, hematocrit, reticulocyte count and hemoglobin) are outside the normal reference ranges, the subject may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate for the population under study;
Key exclusion criteria (38 listed)
- Known previous exposure to filgrastim, pegfilgrastim, granulocyte colony stimulating factor (G-CSF) or any analogue of these;
- Positive test results for anti-PEG-GCSF-antibodies at the Screening Visit or based on historical data (not older than 3 months);
- Known hypersensitivity to the study drug or any of its constituents (e.g., fructose intolerance), hypersensitivity to Escherichia coli derived proteins;
- History of an acute severe allergic reaction (e.g., anaphylaxis; delayed hypersensitivity reaction); concurrent or history of moderate to severe allergy requiring medical treatment (including moderate seasonal allergies); concurrent or history of clinically significant latex allergy;
- Current evidence of atopic eczema or allergic bronchial asthma;
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 |
|---|---|---|
| QL0605Also: pegfilgrastima pegfilgrastim biosimilar to US Neulasta. | Drug | Pegfilgrastim biosimilar product |
| US NeulastaAlso: pegfilgrastimUS Neulasta | Drug | US Neulasta |
Primary outcome
Incidence (absolute and percentage) of ADA by treatment
Time frame: 91 days
Incidence (absolute and percentage) of anti-drug antibody by treatment
6 secondary outcomes
AUC0-t
Time frame: 91 days
AUCinf
Time frame: 91 days
Cmax
Time frame: 91 days
tmax
Time frame: 91 days
AUEC(0-Day41)
Time frame: 41 days
ANC Emax
Time frame: 91 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2020.
- Individual participant dataSharing planned: Undecided
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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.
Thomas Koernicke, MD principal investigator
Parexel International GmbH Early Phase Clinical Unit Berlin
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QL0605 and US Neulasta in people with Healthy, run by Qilu Pharmaceutical Co., Ltd. at 2 sites in 2 countries.
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 27 inclusion and 38 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: status not confirmed, as of the sponsor's last update on 3 Dec 2020. 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 Germany, United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Koernicke, MD (+49 (0)30 30685 9676, Thomas.Koernicke@parexel.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence (absolute and percentage) of ADA by treatment (time frame: 91 days). 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 3 Dec 2020.