An open-label, parallel-group, single-dose study to evaluate the absolute bioavailability and tolerability of subcutaneous UCB4940 in healthy subjects

Completed

• Conditions: psoriasis; rheumatoid arthritis; 10003816

• Registration Number: NL-OMON41792
• Lead Sponsor: CB Celltech

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: 30

Inclusion Criteria

healthy subjects
40-65 years, inclusive
BMI: 19.0-28.0 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 90 days from the start of the study. In case of donating more than 0.4 liters of blood in the 90 days prior the start of this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To determine the Abs BA of single sc doses of UCB4940, 80mg and 160mg, in<br /><br>healthy subjects</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To evaluate the dose proportionality of UCB4940 pharmacokinetics (PK) when<br /><br>given as 80mg or 160mg sc.<br /><br>- To evaluate the safety and tolerability of UCB4940 when given as 80mg sc or<br /><br>160mg sc or 160mg iv</p><br>