A Study in Healthy Volunteers to Compare the Profiles of DA-3880 and EU Sourced ARANESP® (Amgen)

June 13, 2021 updated by: Dong-A ST Co., Ltd.

A Randomized, 2 Part, 4-treatment, 2-way Cross-over Study in Healthy Volunteers to Compare the Pharmacokinetic and Pharmacodynamic Profiles of 1ug/kg of DA-3880 and EU Sourced ARANESP® (Amgen) After Single Intravenous or Subcutaneous Administration

The main purpose of the study is to determine whether the test product and the reference product are bioequivalent based on the pharmacokinetics after administration of ug/kg as a single intravenous dose and as a single subcutaneous dose of each of the formulations. The study is consisted of randomization, 2 parts, 4 treatments, 2 way cross over.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Gender : male or female
  2. Age : 18 - 65 years, inclusive
  3. Body Mass Index (BMI) : 18.0 - 30.0 kg/m2, inclusive
  4. Weight : 55 - 105 kg, inclusive
  5. Female subjects of childbearing potential must be non-pregnant and non-lactating, and have a negative pregnancy test at screening and (each) admission to the clinical research center
  6. Females of child-bearing potential, with a fertile male sexual partner, should be willing to use adequate contraception from screening until 90 days after the follow-up visit. Adequate contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom.
  7. Males should be willing to use adequate contraception and not donate sperm from first admission to the clinical research center until 90 days after the follow-up visit. Adequate contraception for the male subject and his female partner, is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom.
  8. All non-regular medication (including over the counter medication, health supplements, and herbal remedies such as St. John's Wort extract) must have been stopped at least 14 days prior to (the first) admission to the clinical research center. An exception is made for paracetamol (acetaminophen), which is allowed up to admission to the clinical research center. Other exceptions are multivitamins and vitamin C, which are allowed up to 7 days before admission to the clinical research center.
  9. All regular non-topical medication must have been stopped at least 30 days prior to (the first) admission the clinical research center. An exception is made for hormonal contraceptives, which may be used throughout the study.
  10. Ability and willingness to abstain from alcohol, methylxanthine-containing beverages or food (coffee, tea, cola, chocolate, "powerdrinks"), grapefruit (juice) and tobacco products from 48 h prior to each admission to in the clinical research center
  11. Medical history without major pathology as judged by the PI
  12. Normal resting supine blood pressure and pulse showing no clinically relevant deviations as judged by the PI.
  13. Computerized (12-lead) electrocardiogram (ECG) recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the PI.
  14. All values for clinical laboratory tests of blood and urine within the normal range or showing no clinically relevant deviations as judged by the PI. Hb, Hct, RBC count and thrombocytes should not exceed the upper limit of normal. Minor deviations can be accepted at the discretion of the PI
  15. Willing and able to sign the ICF

Exclusion Criteria:

  1. Evidence of clinically relevant pathology
  2. Mental handicap
  3. History of relevant drug and/or food allergies, and/or latex allergy
  4. Smoking more than 10 cigarettes, 2 cigars or 2 pipes daily; the use of tobacco products in the 48 hours (2 days) prior to each admission to the clinical research center is not allowed.
  5. History of alcohol or drug abuse or drug addiction (including soft drugs like cannabis products)
  6. Positive drug screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol)
  7. Average intake of more than 24 units of alcohol per week: one unit of alcohol equals approximately 250 mL of beer, 100 mL of wine or 35 mL of spirits)
  8. Consumption of any foods containing poppy seeds within 48 hours (2 days) prior to each admission to the clinical research center as this could cause a false positive drug screen result
  9. Positive screen on hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or anti-HIV 1 and 2 antibodies
  10. Participation in a drug study within 60 days prior to the screening visit in the current study. Participation in more than 3 other drug studies (for men) and more than 2 other drug studies (for women) in the 10 months prior to the first drug administration in the current study
  11. Donation or loss of more than 100 mL of blood within 60 days prior to the first drug administration. Donation or loss of more than 1.5 liters of blood (for men) / more than 1.0 liters of blood (for women) in the 10 months prior to the first drug administration in the current study.
  12. Strenuous exercise within 96 hours (4 days) prior to each admission to the clinical research center.
  13. Significant and/or acute illness within 5 days prior to the first drug administration that may impact safety assessments, in the opinion of the PI
  14. Vaccination within 30 days prior to entry into the clinical research center or planning a vaccination before the follow-up visit
  15. History of a significant respiratory disorder (such as asthma) or significant immune disorder
  16. Significant infection within 30 days prior to entry into the clinical research center
  17. History of epilepsy; a single febrile convulsion at an age < 6 years is acceptable
  18. History of hemoglobinopathy or abnormal Hb in first-degree relatives
  19. A previous administration of any erythropoiesis-stimulating agent including EPO or darbepoetin, if known
  20. Previous immunoglobulin or iron supplementation within 3 months prior to the screening visit
  21. History of hypersensitivity reactions for any EPO, darbepoetin, iron supplements, or excipient of the investigational product

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IV Administration
The iv solutions containing DA-3880 and Aranesp will be indistinguishable in appearance.
Experimental: SC Administration
The sc solutions containing DA-3880 and Aranesp will be indistinguishable in appearance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetics of DA-3880 and Aranesp via IV Administration
Time Frame: 6 weeks
AUC0-t, Cmax, Tmax, t½, AUC0-inf, %AUC of DA-3880 and EU sourced Aranesp® (Amgen) after administration of 1 μg/kg as a single iv dose will be assessed.
6 weeks
Pharmacokinetics of DA-3880 and Aranesp via SC Administration
Time Frame: 6 weeks
AUC0-t, Cmax, Tmax, t½, AUC0-inf, %AUC of DA-3880 and EU sourced Aranesp® (Amgen) after administration of 1 μg/kg as a single sc dose will be assessed
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacodynamic Variables of DA-3880 and Aranesp
Time Frame: 6 weeks
AUEC0-t, Emax, Tmax of DA-3880 and EU sourced Aranesp® after administration of 1 μg/kg as a single iv dose and as a single sc dose will be assessed.
6 weeks
Safety and Tolerability Parameters of DA-3880 and Aranesp
Time Frame: 6 weeks
Adverse events, vital signs, 12-lead ECG, clinical laboratory tests, physical examination, immunogenicity (anti-drug antibodies), local tolerability of DA-3880 and EU sourced Aranesp® after administration of 1 μg/kg as a single iv dose and as a single sc dose will be assessed.
6 weeks
Pharmacodynamic and Pharmacodynamic Variables of IV and SC Administration
Time Frame: 6 weeks
AUC0-t, Cmax, Tmax, t½, AUC0-inf, %AUC, AUEC0-t, Emax, Tmax of DA-3880 (1 μg/kg) and EU sourced Aranesp® (1 μg/kg) after iv administration with those after sc administration will be assessed.
6 weeks
Safety and Tolerability Parameters of SC and IV Administration
Time Frame: 6 weeks
Adverse events, vital signs, 12-lead ECG, clinical laboratory tests, physical examination, immunogenicity (anti-drug antibodies), local tolerability of DA-3880 (1 μg/kg) and EU sourced Aranesp® (1 μg/kg) after iv administration with those after sc administration will be compared and assessed.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2014

Primary Completion (Actual)

November 29, 2014

Study Completion (Actual)

November 29, 2014

Study Registration Dates

First Submitted

August 29, 2014

First Submitted That Met QC Criteria

September 12, 2014

First Posted (Estimate)

September 16, 2014

Study Record Updates

Last Update Posted (Actual)

June 15, 2021

Last Update Submitted That Met QC Criteria

June 13, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DA3880_ANE_I

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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