An open-label, single-dose, parallel-arm study to evaluate the pharmacokinetics and absolute bioavailability of GBR 830 following single dose administration by the subcutaneous (SC) route

Completed

• Conditions: autoimmune disease; 10003816

• Registration Number: NL-OMON42954
• Lead Sponsor: Glenmark Pharmaceuticals SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

healthy volunteers
18-55 years, inclusive
BMI: 18.5-32.0 kg/m2, inclusive

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 0.45 liters of blood in the 3 months prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine absolute bioavailability of GBR 830 administered by the SC route<br /><br>in healthy adult subjects.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To evaluate the PK of GBR 830 in healthy adult subjects following single dose<br /><br>SC and IV administration.<br /><br>To evaluate the immunogenicity after single doses of GBR 830 in healthy adult<br /><br>subjects following SC and IV administration.<br /><br>To evaluate the safety and tolerability of single doses of GBR 830 in healthy<br /><br>adult subjects.</p><br>