A randomized, open label, two-way cross-over study to determine the pharmacokinetics and safety of GP2015 following a single subcutaneous injection by an autoinjector and by a pre-filled syringe in healthy male subjects

A randomized, open label, two-way cross-over study to determine the pharmacokinetics and safety of GP2015 following a single subcutaneous injection by an autoinjector and by a pre-filled syringe in healthy male subjects - GP2015 bioequivalence study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON40923

Enrollment

Registered

2014-03-04

Start date

2014-03-12

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 rheumatoid arthritis

Interventions

On day 1 of each period, a single dose of 50mg GP2015 subcutaneous injection via an auto-injector or an syringe is administered.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Subjects must give written informed consent before any assessment is performed;- Male subjects, aged 18 to 55 years inclusive ;- Physically and mentally healthy, as determined by physical examination and safety laboratory;- Body weight between 50 to 140 kg and body mass index (BMI) between 18.5 to 49.9 kg/m2 inclusively;- Non-smoker or ex-smoker, defined as not having smoked for at least 6 months before IMP administration

Exclusion criteria

Exclusion criteria: Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 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
Bioequivalence	—

Secondary

Measure	Time frame
Pharmacokinetics and safety and tolerability.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)