A randomized, 2 part, 4-treatment, 2-way cross-over study in healthy volunteers to compare the pharmacokinetic and pharmacodynamics profiles of 1 *g/kg of DA-3880 and EU sourced AND EU Aranesp® (AMGEN) after single intravenous or subcutaneous administration

A randomized, 2 part, 4-treatment, 2-way cross-over study in healthy volunteers to compare the pharmacokinetic and pharmacodynamics profiles of 1 *g/kg of DA-3880 and EU sourced AND EU Aranesp® (AMGEN) after single intravenous or subcutaneous administration - DA-3880 bio-similarity study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41044

Enrollment

Registered

2014-07-01

Start date

2014-07-31

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

anemia

Interventions

During the study the volunteer will receive DA-3880 or Aranesp® after a breakfast, starting 30 minutes before medication administration and which has to be completed before administration of the stu

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy volunteers 18-65 years, inclusive BMI: 18.0-30.0 kg/m2, inclusive

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.

Design outcomes

Primary

Measure	Time frame
To demonstrate bioequivalence of DA-3880, and EU sourced Aranesp® (Amgen) after administration of 1 µg/kg as a single iv dose in terms of PK parameters To demonstrate bioequivalence of DA-3880, and EU sourced Aranesp® (Amgen) after administration of 1 µg/kg as a single sc dose in terms of PK parameters	—

Secondary

Measure	Time frame
To compare the PD of DA-3880 and EU sourced Aranesp® after administration of 1 µg/kg as a single iv dose and as a single sc dose To compare the safety, tolerability and immunogenicity of DA-3880 and EU sourced Aranesp® after administration of 1 µg/kg as a single iv dose and as a single sc dose To compare the PK and PD of DA-3880 (1 µg/kg) and EU sourced Aranesp® (1 µg/kg) after iv administration with those after sc administration To compare the safety, tolerability and immunogenicity of DA-3880 (1 µg/kg) and EU sourced Aranesp® (1 µg/kg) after iv administration with those after sc administration	—

Measure

Time frame

To compare the PD of DA-3880 and EU sourced Aranesp® after administration of 1 µg/kg as a single iv dose and as a single sc dose To compare the safety, tolerability and immunogenicity of DA-3880 and EU sourced Aranesp® after administration of 1 µg/kg as a single iv dose and as a single sc dose To compare the PK and PD of DA-3880 (1 µg/kg) and EU sourced Aranesp® (1 µg/kg) after iv administration with those after sc administration To compare the safety, tolerability and immunogenicity of DA-3880 (1 µg/kg) and EU sourced Aranesp® (1 µg/kg) after iv administration with those after sc administration

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)