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

Completed

• Conditions: autoimmune diseases; including rheumatoid arthritis and psoriasis; 10003816

• Registration Number: NL-OMON42002
• Lead Sponsor: Hexal AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 108

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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