A Phase 1 Study to Assess the Immunogenicity of QL0605 Compared to US Neulasta in Healthy Subjects

NCT04651036 | Unknown Phase 1

• 1 other identifier: QL0605-OVE-002
• Study Type: interventional
• Target: 300
• Locations: 2 countries
• Sites: 2

Brief 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. proposed biosimilar QL0605 compared to innovator product, US-Neulasta) in healthy, adult, human subjects.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence (absolute and percentage) of ADA by treatment

  Incidence (absolute and percentage) of anti-drug antibody by treatment

  91 days

Secondary Outcomes (6)

• AUC0-t

  91 days

• AUCinf

  91 days

• Cmax

  91 days

• tmax

  91 days

• AUEC(0-Day41)

  41 days

Study Arms (2)

Pegfilgrastim biosimilar product

EXPERIMENTAL

QL0605 subcutaneously at a dose of 6 mg/0.6 mL.

Drug: QL0605

US Neulasta

ACTIVE COMPARATOR

US Neulasta subcutaneously at a dose of 6 mg/0.6 mL.

Drug: US Neulasta

Interventions

QL0605 DRUG

a pegfilgrastim biosimilar to US Neulasta.

Also known as: pegfilgrastim

Pegfilgrastim biosimilar product

US Neulasta DRUG

US Neulasta

Also known as: pegfilgrastim

US Neulasta

Eligibility Criteria

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

You may qualify if:

• 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:
• 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)

You may not qualify if:

• 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;
• 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.
• 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;

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (2)

Parexel International GmbH Early Phase Clinical Unit Berlin

Berlin, Germany

NOT YET RECRUITING

Parexel Early Phase Clinical Unit

London, United Kingdom

RECRUITING

MeSH Terms

Interventions

pegfilgrastim

Study Officials

• Thomas Koernicke, MD

  Parexel International GmbH Early Phase Clinical Unit Berlin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Koernicke, MD

CONTACT

+49 (0)30 30685 9676; Thomas.Koernicke@parexel.com

Jana Wolfova, MD

CONTACT

+44 (0)1895 614249; Jana.Wolfova@parexel.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: November 9, 2020
• First Posted: December 3, 2020
• Study Start: November 6, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2022
• Last Updated: December 3, 2020

Record last verified: 2020-11

Locations

DE (1); GB (1)