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Symptomatic AnemiaPhase 1NCT02241200

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

A Phase 1 study testing DA3880 and Aranesp in people with Symptomatic Anemia, run by Dong-A ST Co., Ltd. at 1 site in Netherlands.

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

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. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Symptomatic Anemia
What is being tested?
DA3880 and Aranesp
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 siteNetherlands
Study dates
18 Aug 2014to 29 Nov 2014
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 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Gender : male or female
  • Age : 18 - 65 years, inclusive
  • Body Mass Index (BMI) : 18.0 - 30.0 kg/m2, inclusive
  • Weight : 55 - 105 kg, inclusive
  • 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
  • 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.
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  • 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.
  • 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.
  • 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.
  • 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
  • Medical history without major pathology as judged by the PI
  • Normal resting supine blood pressure and pulse showing no clinically relevant deviations as judged by the PI.
  • Computerized (12-lead) electrocardiogram (ECG) recording without signs of clinically relevant pathology or showing no clinically relevant deviations as judged by the PI.
  • 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
  • Willing and able to sign the ICF

Who cannot join

  • Evidence of clinically relevant pathology
  • Mental handicap
  • History of relevant drug and/or food allergies, and/or latex allergy
  • 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.
  • History of alcohol or drug abuse or drug addiction (including soft drugs like cannabis products)
  • Positive drug screen (opiates, methadone, cocaine, amphetamines [including ecstasy], cannabinoids, barbiturates, benzodiazepines, tricyclic antidepressants and alcohol)
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  • 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)
  • 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
  • Positive screen on hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibodies or anti-HIV 1 and 2 antibodies
  • 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
  • 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.
  • Strenuous exercise within 96 hours (4 days) prior to each admission to the clinical research center.
  • 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
  • Vaccination within 30 days prior to entry into the clinical research center or planning a vaccination before the follow-up visit
  • History of a significant respiratory disorder (such as asthma) or significant immune disorder
  • Significant infection within 30 days prior to entry into the clinical research center
  • History of epilepsy; a single febrile convulsion at an age < 6 years is acceptable
  • History of hemoglobinopathy or abnormal Hb in first-degree relatives
  • A previous administration of any erythropoiesis-stimulating agent including EPO or darbepoetin, if known
  • Previous immunoglobulin or iron supplementation within 3 months prior to the screening visit
  • History of hypersensitivity reactions for any EPO, darbepoetin, iron supplements, or excipient of the investigational product

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • PRA

    Zuidlaren, 9471

Other trials in Netherlands

About this study

Official title: 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.

Being tested
DA3880, Aranesp

What participants receive

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

  • DA3880Drug

  • AranespDrug

Study groups in NCT02241200
Study groupRoleWhat they receive
IV AdministrationExperimentalThe iv solutions containing DA-3880 and Aranesp will be indistinguishable in appearance.
Receives: Drug: DA3880; Drug: Aranesp
SC AdministrationExperimentalThe sc solutions containing DA-3880 and Aranesp will be indistinguishable in appearance.
Receives: Drug: DA3880; Drug: Aranesp

What is being measured

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

  1. Pharmacokinetics of DA-3880 and Aranesp via IV Administration

    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.

    Measured: 6 weeks

  2. Pharmacokinetics of DA-3880 and Aranesp via SC Administration

    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

    Measured: 6 weeks

Secondary outcomes (4)

  1. Pharmacodynamic Variables of DA-3880 and Aranesp

    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.

    Measured: 6 weeks

  2. Safety and Tolerability Parameters of DA-3880 and Aranesp

    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.

    Measured: 6 weeks

  3. Pharmacodynamic and Pharmacodynamic Variables of IV and SC Administration

    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.

    Measured: 6 weeks

  4. Safety and Tolerability Parameters of SC and IV Administration

    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.

    Measured: 6 weeks

Timeline

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

  1. First posted16 Sep 2014 (estimated)
  2. Study start18 Aug 2014
  3. Primary completion29 Nov 2014
  4. Study completion29 Nov 2014

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
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02241200
Sponsor's protocol ID
DA3880_ANE_I
Status last verified
Jun 2021
First submitted
29 Aug 2014
Last updated
15 Jun 2021
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing DA3880 and Aranesp in people with Symptomatic Anemia, run by Dong-A ST Co., Ltd. at 1 site in Netherlands.

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 15 inclusion and 21 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 15 Jun 2021. 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 Netherlands. 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?

Pharmacokinetics of DA-3880 and Aranesp via IV Administration (time frame: 6 weeks). The study lists 2 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 NCT02241200.

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 15 Jun 2021.

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