A randomized, open-label, single-dose parallel-group trial to determine the pharmacokinetics and safety of GP2017 following a single subcutaneous injection by an autoinjector or by a pre-filled syringe in healthy male subjects

A randomized, open-label, single-dose parallel-group trial to determine the pharmacokinetics and safety of GP2017 following a single subcutaneous injection by an autoinjector or by a pre-filled syringe in healthy male subjects - GP2017 biosimilar study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42002

Enrollment

108

Registered

2014-12-01

Start date

2015-01-19

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

autoimmune diseases including rheumatoid arthritis and psoriasis

Interventions

The study will consist of 1 period during which the volunteer will receive one single subcutaneous injection of 40 mg GP2017 diluted in 0.8 ml solution on Day 1.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - healthy male volunteers - age 18 - 55 inclusive - BMI between 18.0 and 49.9 kilograms/meter2 - weight between 50.0 and 140.0 kg

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 12 weeks from the start of the study.

Design outcomes

Primary

Measure	Time frame
To describe pharmacokinetics of GP2017 administered by an autoinjector (delta-GP2017_40) or a PFS as a single subcutaneous injection of 40 mg to healthy adult male subjects with body weights between 50.0 * 94.9 kg in terms of the pharmacokinetic parameters AUC0*360h and Cmax.	—

Secondary

Measure	Time frame
* Pharmacokinetic parameters in subjects with body weights between 50.0 * 94.9kg in terms of AUC0last, AUC0* * Pharmacokinetic parameters in subjects with body weights between 50.0 * 94.9kg in terms of %AUCextrap, tmax, CL0last, kel and t1/2. All pharmacokinetic parameters within following weight categories (50.0-64.9 kg, 65.0-79.9 kg, 80.0-94.9 kg, 95.0- 140.0 kg) * Overall safety, immunogenicity, tolerability and local tolerance	—

Measure

Time frame

* Pharmacokinetic parameters in subjects with body weights between 50.0 * 94.9kg in terms of AUC0*last, AUC0** * Pharmacokinetic parameters in subjects with body weights between 50.0 * 94.9kg in terms of %AUCextrap, tmax, CL0*last, kel and t1/2. * All pharmacokinetic parameters within following weight categories (50.0-64.9 kg, 65.0-79.9 kg, 80.0-94.9 kg, 95.0- 140.0 kg) * Overall safety, immunogenicity, tolerability and local tolerance

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)